Zintoma Ginger 750 mg/day × Rhodes Nausea Subscore Over 4 Days in Early Pregnancy

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich early-pregnancy nausea question does the table cover?Required	The original claim is reduced nausea severity in early pregnancy. Vomiting frequency, admission and pregnancy outcomes remain separate. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	The comparison boundary for nausea severity between oral Zintoma capsules and placebo	Material needed: Original-trial eligibility/endpoint tables and prespecified plans. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhich pregnant population is represented?Required	The retained population is women with singleton pregnancies before 16 weeks and mild or moderate nausea/vomiting. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Eligibility for singleton pregnancy before 16 weeks with mild or moderate nausea/vomiting	Material needed: Recruitment/eligibility tables and baseline characteristics. This records needed materials; no new research was executed.
3	Unverified	Full text not readStored summary read	N03 · Evidence conditionIs this the same treatment question as hyperemesis gravidarum?Required	The original record states that findings cannot be extended to replacement of hyperemesis treatment. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Distinction between mild/moderate nausea and severe hyperemesis gravidarum	Material needed: Severity definitions and hyperemesis-comparison results. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionIs the ginger formulation and product the same?Required	The retained product is Zintoma 250 mg capsules; gingerol/shogaol assays and extraction methods remain unverified. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Manufacturing, extraction and ingredient assays for Zintoma 250 mg capsules	Material needed: Product/batch and ingredient-analysis material. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat is the intervention route?Required	The selected route is oral. The original record limits interchangeability among foods, powders, standardized extracts, oils, topical products and combinations. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Distinction between oral capsules and foods, oils, topical products and combinations	Material needed: Intervention-administration records. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhat were the dose and intake frequency?Required	The retained dose is 250 mg, 3 times daily, totaling 750 mg/day. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Actual administration/adherence for 250 mg, 3 times daily, with a total of 750 mg/day	Material needed: Administration and medication-adherence records. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre duration and measurement times distinguished?Required	The retained intervention description records treatment over 4 days. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Treatment over 4 days and the nausea-measurement schedule	Material needed: Visit schedules and endpoint-measurement tables. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat was the common dietary advice in the placebo comparison?Required	The comparator is recorded as the same dietary advice and lactose placebo capsules. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	A comparison retaining the same dietary advice and lactose placebo	Material needed: Dietary-advice, concurrent-treatment and rescue-treatment records. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionHow is the direct report identified?Required	The retained bibliography records Saberi 2014, PMID 25414888, PMCID PMC4228518 and DOI 10.17795/nmsjournal11841. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Retained links among the Saberi report title, PMID, PMCID and DOI	Material needed: Original paper and bibliographic record. This records needed materials; no new research was executed.
10	Unverified	Full text not readStored summary read	N10 · Evidence conditionDo a registration number and registration content have the same verification level?Required	The bibliography contains IRCT201103192699N4, while registration status in the original record remains unverified. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Bibliographic IRCT201103192699N4 wording and the actual registration document	Material needed: Original registration and its history. This records needed materials; no new research was executed.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionWas the nausea-only endpoint prespecified?Required	The original record states that the prespecified hierarchy for the selected nausea-only endpoint was insufficient. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Prespecified hierarchy, analysis and timing of the Rhodes nausea subscore	Material needed: Protocol, statistical analysis plan and registered endpoints. This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionHow was 3-arm randomization performed?Required	The direct report is retained as a 3-arm randomized placebo-controlled trial. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Allocation sequence, concealment, arm definitions and recruitment flow	Material needed: Allocation methods and arm-specific participant flow. This records needed materials; no new research was executed.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionWere blinding and a similar placebo maintained?Required	The summary includes placebo capsules and the same dietary advice. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Participant/assessor blinding and sensory placebo matching	Material needed: Placebo composition, blinding methods and unblinding records. This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWhat were the overall 3-arm and main-analysis denominators?Required	The retained denominators are 120 allocated and 106 in the main analysis. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Distinction between 120 allocated and 106 in the main analysis overall	Material needed: Arm-specific flow diagrams and analysis-population definitions. This records needed materials; no new research was executed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhat were the denominators of the selected direct comparison?Required	The retained direct comparison has 80 allocated and 73 analyzed. These are not added to the overall 120 and 106. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Distinction between 80 allocated/73 analyzed in the direct comparison and all 3 arms	Material needed: Arm-specific allocated/analyzed counts for the selected comparison. This records needed materials; no new research was executed.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionWhat were the losses to observation and analysis assumptions?Required	The current summary distinguishes allocated participants from those in the main analysis. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Withdrawal reasons, missing-data handling, ITT and adherence analyses	Material needed: Withdrawal, missing-data handling and analysis plans. This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionHow was the Rhodes subscore measured?Required	The selected endpoint is change in the Rhodes nausea subscore. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Nausea-subscore scale, direction, baseline and measurement times	Material needed: Scale/questionnaire, baseline and measurement tables. This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhat do reductions of 3.86 and 1.26 mean?Required	The retained result is a reduction of 3.86±2.35 versus 1.26±1.57. These values are recorded unchanged without creating a new difference. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Arm-specific reductions, spread values and arm mapping	Material needed: Original result tables and analysis output. This records needed materials; no new research was executed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionIs P=.001 the test of the selected two arms?Required	The original P=.001 is retained as coming from the 3-arm ANOVA. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Distinction between the 3-arm ANOVA and pairwise-comparison P values	Material needed: 3-arm/pairwise analysis tables and analysis plans. This records needed materials; no new research was executed.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionIs an exact interval available for the pairwise effect?Required	The current summary leaves the exact pairwise CI unverified. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Effect estimate and confidence interval for the selected direct comparison	Material needed: Original tables of between-group estimates and 95% CIs. This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionIs the score difference clinically important?Required	The retained material describes a signal of improved nausea scores. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Minimum important difference, responder criteria and patient-important outcomes	Material needed: Important-difference evidence and responder results. This records needed materials; no new research was executed.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionWhich comparison does the pooled meta-analysis result represent?Required	The retained meta-analysis records 13 studies with 1,174 people and nausea versus placebo with SMD 0.821, 95% CI 0.585~1.056 and I²=38.9%. S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	The 13 studies with 1,174 people and SMD for nausea severity versus placebo	Material needed: Original meta-analysis, inclusion tables and pooled models. This records needed materials; no new research was executed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionIs the vitamin B6 comparison the same as placebo?Required	The original record and meta-analysis summary record a null result against B6, distinguished from improvement versus placebo. S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Separation of active-comparator B6 and placebo comparisons	Material needed: Comparator-specific results and B6 administration conditions. This records needed materials; no new research was executed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionHow varied were formulations, doses and scales across pooled trials?Required	The original record describes varied formulations, doses, scales and quality across included trials and retains I²=38.9%. S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	I² and variation in formulations, doses, scales and methodology	Material needed: Trial-specific formulation, dose, scale and methods tables. This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionAre the same original trials counted repeatedly?Required	The original record states that meta-analyses share many original trials. Direct-trial and pooled denominators are not added. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Relationships among reports, trials and meta-analysis inclusion	Material needed: Report-trial mapping and included-trial lists. This records needed materials; no new research was executed.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionWhat scope of information does university funding provide?Required	The retained direct-trial funding is Kashan University grant 8614. The meta-analysis is recorded as having university affiliations and mixed original-trial funding. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Kashan University grant 8614 and research-funding relationships	Material needed: Funding statements, contracts and research-role disclosures. This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionAre product supply, employee authors and COI separately verified?Required	University grant wording and generic English funding wording are retained. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Free product support, company roles, employee authorship and conflicts beyond funding	Material needed: Original product-support, affiliation and COI statements. This records needed materials; no new research was executed.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionHow were short-term discomfort and drug interactions recorded?Supplementary	The retained safety description notes caution about acid reflux, abdominal discomfort, diarrhea and possible drug interactions. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Reflux, abdominal discomfort, diarrhea, concurrent drugs and collection methods	Material needed: Adverse-event tables, collection methods and concurrent-drug records. This records needed materials; no new research was executed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionAre pregnancy outcomes and long-term maternal/fetal safety answered?Supplementary	The original record limits interpretation: nausea-score benefit does not answer long-term maternal/fetal safety. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Pregnancy outcomes, miscarriage, long-term maternal/fetal follow-up and denominators	Material needed: Pregnancy-outcome and exposure/follow-up denominator material. This records needed materials; no new research was executed.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionWhat level of information do references to ACOG, NCCIH and EMA provide?Supplementary	The original record states that ACOG, NCCIH and EMA material was compared and summarizes NCCIH consultation advice and EMA precautionary caution. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Actual agency-specific wording, products and dose material	Material needed: Agency-document versions and original text locations. This records needed materials; no new research was executed.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionCan findings extend to vomiting frequency, admission or hyperemesis treatment?Required	The original record records a null pooled result for vomiting frequency and makes no claim of admission prevention or replacement of hyperemesis treatment. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Direct comparisons and null findings for other endpoints	Material needed: Original endpoint-specific vomiting and admission result tables. This records needed materials; no new research was executed.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionHow are English wording and historical corrections retained?Required	Current English wording and the correction event for 2 fields are preserved unchanged. Some generic English wording in the original evidence summaries does not replace verification of specific values. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Current Korean/English wording and the English placeholder correction of 2026-09-14	Material needed: Original wording before/after correction and translation mapping. This records needed materials; no new research was executed.
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionHow are the C score of 50, axes and historical independent cross-check retained?Required	The current C score of 50, original axes and previous independent cross-check wording are original values. They are not inherited as fulfilled conditions or completed new review in this preparation. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Historical preservation of the original grade, score, axes, verdict date and previous verification wording	Material needed: Additional review comments and future correction material. This records needed materials; no new research was executed.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionWhat was actually read, and what do the dates mean?Required	Preparation read the complete stored summary. The original verdict date is 2026-09-08 and the correction date is 2026-09-14. External originals, registration and plans remain unread. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Distinction between the stored record and external-paper, registration and planning material read	Material needed: Required originals, registration, protocol and SAP material when provided. This records needed materials; no new research was executed.

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34 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-08
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Population: Women with singleton pregnancies before 16 weeks and mild or moderate nausea/vomiting
Ingredient, formulation and route: Oral Zintoma capsules derived from the rhizome of Zingiber officinale Roscoe. Gingerol/shogaol assays, extraction methods, batches and standardization remain unverified.
Dose: A 250 mg capsule 3 times daily, with a retained daily total of 750 mg/day. This is not changed into another formulation or a converted active-ingredient amount.
Comparator: The same dietary advice and lactose placebo capsules. Adherence to dietary advice and details of concurrent and rescue treatment remain unverified.
Measured outcome: Change in the Rhodes nausea subscore. The prespecified hierarchy for nausea alone and details of scale, score direction, assessor, baseline and daily measurements remain unverified.
Duration: Treatment over 4 days. Persistence afterward and long-term maternal/fetal follow-up remain unverified.
Questions outside this scope: Transfer of the same effect to foods, powders, other extracts, oils, topical products or combinations; Extension of nausea-score improvement to vomiting frequency, admission or pregnancy outcomes; Interpretation of placebo comparisons as equivalence or noninferiority against an active comparator; Replacement of hyperemesis treatment or establishment of long-term maternal/fetal safety

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Saberi et al. (2014): Effect of Ginger on Relieving Nausea and Vomiting in Pregnancy: A Randomized, Placebo-Controlled Trial

PubMed

Material type: Report of a 3-arm randomized placebo-controlled trial
Materials actually read: Stored summary and bibliography read; external paper, registration and planning material unread
Findings recorded in the stored summary: Overall 120 allocated and 106 in the main analysis; direct comparison of 80 allocated and 73 analyzed. Reductions of 3.86±2.35 versus 1.26±1.57 are retained. The definition of ± and arm mapping remain unverified. P=.001 is from the 3-arm ANOVA; exact pairwise P and 95% CI remain unverified.
Record level: Reductions and all-arm test in a stored summary; exact pairwise effect unverified
Study overlap and independent replication: The inclusion relationship and overlap between the direct trial and meta-analysis remain unverified. The overall 120 allocated and 106 in the main analysis, selected direct comparison of 80 allocated and 73 analyzed, and pooled 13 studies with 1,174 people are not added together. Unique trials, participant totals and independent replications matching the product conditions remain unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Existing stored summary acquired	Stored summary	Stored summary read	The stored existing evidence and bibliography summary was read. Saberi F et al. Nurs Midwifery Stud. 2014. PMID: 25414888. PMCID: PMC4228518. DOI: 10.17795/nmsjournal11841. IRCT201103192699N4. Bibliographic IRCT201103192699N4 and PMC4228518 are distinguished from unverified registration status in the original record. Identifiers do not establish current reading of registration content, prospective timing, endpoints, changes or full text. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
External article, abstract and full text	Original bibliography link only; external content unread	Unread; no access attempt	Unread	Only the bibliographic article/abstract/full-text link is retained. External content is unread, with no access attempt. Bibliographic IRCT201103192699N4 and PMC4228518 are distinguished from unverified registration status in the original record. Identifiers do not establish current reading of registration content, prospective timing, endpoints, changes or full text. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Registration material	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	Original registration/changes and prespecified endpoints remain unread. Bibliographic IRCT201103192699N4 and PMC4228518 are distinguished from unverified registration status in the original record. Identifiers do not establish current reading of registration content, prospective timing, endpoints, changes or full text. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Protocol	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	The original protocol and its changes remain unread. Bibliographic IRCT201103192699N4 and PMC4228518 are distinguished from unverified registration status in the original record. Identifiers do not establish current reading of registration content, prospective timing, endpoints, changes or full text. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Statistical analysis plan (SAP)	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	The original prespecified statistical analysis plan and multiplicity plan remain unread. Bibliographic IRCT201103192699N4 and PMC4228518 are distinguished from unverified registration status in the original record. Identifiers do not establish current reading of registration content, prospective timing, endpoints, changes or full text. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Funding, product-support and conflict material	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	Original funding, product-support, employee-authorship and conflict disclosures remain unread. Bibliographic IRCT201103192699N4 and PMC4228518 are distinguished from unverified registration status in the original record. Identifiers do not establish current reading of registration content, prospective timing, endpoints, changes or full text. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.

S02 · Hu et al. (2022): Effect of ginger in the treatment of nausea and vomiting compared with vitamin B6 and placebo during pregnancy: a meta-analysis

PubMed

Material type: Report of a meta-analysis of randomized trials
Materials actually read: Stored summary and bibliography read; external paper, registration and planning material unread
Findings recorded in the stored summary: In 13 studies with 1,174 people, nausea versus placebo had SMD 0.821, 95% CI 0.585~1.056 and I²=38.9%. The null comparison against B6 is distinguished from placebo and does not prove equivalence. Formulations, doses, scales and methods vary; product-specific effects and exact sign conventions remain unverified.
Record level: Retained pooled nausea result and active-comparator boundary; not a product-specific effect
Study overlap and independent replication: The inclusion relationship and overlap between the direct trial and meta-analysis remain unverified. The overall 120 allocated and 106 in the main analysis, selected direct comparison of 80 allocated and 73 analyzed, and pooled 13 studies with 1,174 people are not added together. Unique trials, participant totals and independent replications matching the product conditions remain unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Existing stored summary acquired	Stored summary	Stored summary read	The stored existing evidence and bibliography summary was read. Hu Y et al. J Matern Fetal Neonatal Med. 2022;35:187-196. PMID: 31937153. DOI: 10.1080/14767058.2020.1712714. Registration status in the original record remains unverified and no full-text copy is retained. Shared historical review wording is not inherited as current external reading of this report. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
External article, abstract and full text	Original bibliography link only; external content unread	Unread; no access attempt	Unread	Only the bibliographic article/abstract/full-text link is retained. External content is unread, with no access attempt. Registration status in the original record remains unverified and no full-text copy is retained. Shared historical review wording is not inherited as current external reading of this report. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Registration material	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	Original registration/changes and prespecified endpoints remain unread. Registration status in the original record remains unverified and no full-text copy is retained. Shared historical review wording is not inherited as current external reading of this report. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Protocol	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	The original protocol and its changes remain unread. Registration status in the original record remains unverified and no full-text copy is retained. Shared historical review wording is not inherited as current external reading of this report. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Statistical analysis plan (SAP)	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	The original prespecified statistical analysis plan and multiplicity plan remain unread. Registration status in the original record remains unverified and no full-text copy is retained. Shared historical review wording is not inherited as current external reading of this report. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Funding, product-support and conflict material	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	Original funding, product-support, employee-authorship and conflict disclosures remain unread. Registration status in the original record remains unverified and no full-text copy is retained. Shared historical review wording is not inherited as current external reading of this report. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.

Report counts versus independent study counts

The inclusion relationship and overlap between the direct trial and meta-analysis remain unverified. The overall 120 allocated and 106 in the main analysis, selected direct comparison of 80 allocated and 73 analyzed, and pooled 13 studies with 1,174 people are not added together. Unique trials, participant totals and independent replications matching the product conditions remain unverified.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which early-pregnancy nausea question does the table cover?

Required materials and conditions: The comparison boundary for nausea severity between oral Zintoma capsules and placebo
Conditions for verification: Original material and analysis scope on The comparison boundary for nausea severity between oral Zintoma capsules and placebo must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on The comparison boundary for nausea severity between oral Zintoma capsules and placebo is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N02 · Which pregnant population is represented?

Required materials and conditions: Eligibility for singleton pregnancy before 16 weeks with mild or moderate nausea/vomiting
Conditions for verification: Original material and analysis scope on Eligibility for singleton pregnancy before 16 weeks with mild or moderate nausea/vomiting must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Eligibility for singleton pregnancy before 16 weeks with mild or moderate nausea/vomiting is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N03 · Is this the same treatment question as hyperemesis gravidarum?

Required materials and conditions: Distinction between mild/moderate nausea and severe hyperemesis gravidarum
Conditions for verification: Original material and analysis scope on Distinction between mild/moderate nausea and severe hyperemesis gravidarum must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Distinction between mild/moderate nausea and severe hyperemesis gravidarum is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N04 · Is the ginger formulation and product the same?

Required materials and conditions: Manufacturing, extraction and ingredient assays for Zintoma 250 mg capsules
Conditions for verification: Original material and analysis scope on Manufacturing, extraction and ingredient assays for Zintoma 250 mg capsules must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Manufacturing, extraction and ingredient assays for Zintoma 250 mg capsules is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N05 · What is the intervention route?

Required materials and conditions: Distinction between oral capsules and foods, oils, topical products and combinations
Conditions for verification: Original material and analysis scope on Distinction between oral capsules and foods, oils, topical products and combinations must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Distinction between oral capsules and foods, oils, topical products and combinations is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N06 · What were the dose and intake frequency?

Required materials and conditions: Actual administration/adherence for 250 mg, 3 times daily, with a total of 750 mg/day
Conditions for verification: Original material and analysis scope on Actual administration/adherence for 250 mg, 3 times daily, with a total of 750 mg/day must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Actual administration/adherence for 250 mg, 3 times daily, with a total of 750 mg/day is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N07 · Are duration and measurement times distinguished?

Required materials and conditions: Treatment over 4 days and the nausea-measurement schedule
Conditions for verification: Original material and analysis scope on Treatment over 4 days and the nausea-measurement schedule must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Treatment over 4 days and the nausea-measurement schedule is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N08 · What was the common dietary advice in the placebo comparison?

Required materials and conditions: A comparison retaining the same dietary advice and lactose placebo
Conditions for verification: Original material and analysis scope on A comparison retaining the same dietary advice and lactose placebo must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on A comparison retaining the same dietary advice and lactose placebo is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N09 · How is the direct report identified?

Required materials and conditions: Retained links among the Saberi report title, PMID, PMCID and DOI
Conditions for verification: Original material and analysis scope on Retained links among the Saberi report title, PMID, PMCID and DOI must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Retained links among the Saberi report title, PMID, PMCID and DOI is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N10 · Do a registration number and registration content have the same verification level?

Required materials and conditions: Bibliographic IRCT201103192699N4 wording and the actual registration document
Conditions for verification: Original material and analysis scope on Bibliographic IRCT201103192699N4 wording and the actual registration document must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Bibliographic IRCT201103192699N4 wording and the actual registration document is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N11 · Was the nausea-only endpoint prespecified?

Required materials and conditions: Prespecified hierarchy, analysis and timing of the Rhodes nausea subscore
Conditions for verification: Original material and analysis scope on Prespecified hierarchy, analysis and timing of the Rhodes nausea subscore must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Prespecified hierarchy, analysis and timing of the Rhodes nausea subscore is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N12 · How was 3-arm randomization performed?

Required materials and conditions: Allocation sequence, concealment, arm definitions and recruitment flow
Conditions for verification: Original material and analysis scope on Allocation sequence, concealment, arm definitions and recruitment flow must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Allocation sequence, concealment, arm definitions and recruitment flow is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N13 · Were blinding and a similar placebo maintained?

Required materials and conditions: Participant/assessor blinding and sensory placebo matching
Conditions for verification: Original material and analysis scope on Participant/assessor blinding and sensory placebo matching must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Participant/assessor blinding and sensory placebo matching is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N14 · What were the overall 3-arm and main-analysis denominators?

Required materials and conditions: Distinction between 120 allocated and 106 in the main analysis overall
Conditions for verification: Original material and analysis scope on Distinction between 120 allocated and 106 in the main analysis overall must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Distinction between 120 allocated and 106 in the main analysis overall is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N15 · What were the denominators of the selected direct comparison?

Required materials and conditions: Distinction between 80 allocated/73 analyzed in the direct comparison and all 3 arms
Conditions for verification: Original material and analysis scope on Distinction between 80 allocated/73 analyzed in the direct comparison and all 3 arms must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Distinction between 80 allocated/73 analyzed in the direct comparison and all 3 arms is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N16 · What were the losses to observation and analysis assumptions?

Required materials and conditions: Withdrawal reasons, missing-data handling, ITT and adherence analyses
Conditions for verification: Original material and analysis scope on Withdrawal reasons, missing-data handling, ITT and adherence analyses must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Withdrawal reasons, missing-data handling, ITT and adherence analyses is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N17 · How was the Rhodes subscore measured?

Required materials and conditions: Nausea-subscore scale, direction, baseline and measurement times
Conditions for verification: Original material and analysis scope on Nausea-subscore scale, direction, baseline and measurement times must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Nausea-subscore scale, direction, baseline and measurement times is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N18 · What do reductions of 3.86 and 1.26 mean?

Required materials and conditions: Arm-specific reductions, spread values and arm mapping
Conditions for verification: Original material and analysis scope on Arm-specific reductions, spread values and arm mapping must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Arm-specific reductions, spread values and arm mapping is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N19 · Is P=.001 the test of the selected two arms?

Required materials and conditions: Distinction between the 3-arm ANOVA and pairwise-comparison P values
Conditions for verification: Original material and analysis scope on Distinction between the 3-arm ANOVA and pairwise-comparison P values must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Distinction between the 3-arm ANOVA and pairwise-comparison P values is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N20 · Is an exact interval available for the pairwise effect?

Required materials and conditions: Effect estimate and confidence interval for the selected direct comparison
Conditions for verification: Original material and analysis scope on Effect estimate and confidence interval for the selected direct comparison must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Effect estimate and confidence interval for the selected direct comparison is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N21 · Is the score difference clinically important?

Required materials and conditions: Minimum important difference, responder criteria and patient-important outcomes
Conditions for verification: Original material and analysis scope on Minimum important difference, responder criteria and patient-important outcomes must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Minimum important difference, responder criteria and patient-important outcomes is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N22 · Which comparison does the pooled meta-analysis result represent?

Required materials and conditions: The 13 studies with 1,174 people and SMD for nausea severity versus placebo
Conditions for verification: Original material and analysis scope on The 13 studies with 1,174 people and SMD for nausea severity versus placebo must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on The 13 studies with 1,174 people and SMD for nausea severity versus placebo is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N23 · Is the vitamin B6 comparison the same as placebo?

Required materials and conditions: Separation of active-comparator B6 and placebo comparisons
Conditions for verification: Original material and analysis scope on Separation of active-comparator B6 and placebo comparisons must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Separation of active-comparator B6 and placebo comparisons is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N24 · How varied were formulations, doses and scales across pooled trials?

Required materials and conditions: I² and variation in formulations, doses, scales and methodology
Conditions for verification: Original material and analysis scope on I² and variation in formulations, doses, scales and methodology must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on I² and variation in formulations, doses, scales and methodology is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N25 · Are the same original trials counted repeatedly?

Required materials and conditions: Relationships among reports, trials and meta-analysis inclusion
Conditions for verification: Original material and analysis scope on Relationships among reports, trials and meta-analysis inclusion must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Relationships among reports, trials and meta-analysis inclusion is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N26 · What scope of information does university funding provide?

Required materials and conditions: Kashan University grant 8614 and research-funding relationships
Conditions for verification: Original material and analysis scope on Kashan University grant 8614 and research-funding relationships must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Kashan University grant 8614 and research-funding relationships is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N27 · Are product supply, employee authors and COI separately verified?

Required materials and conditions: Free product support, company roles, employee authorship and conflicts beyond funding
Conditions for verification: Original material and analysis scope on Free product support, company roles, employee authorship and conflicts beyond funding must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Free product support, company roles, employee authorship and conflicts beyond funding is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N28 · How were short-term discomfort and drug interactions recorded?

Required materials and conditions: Reflux, abdominal discomfort, diarrhea, concurrent drugs and collection methods
Conditions for verification: Original material and analysis scope on Reflux, abdominal discomfort, diarrhea, concurrent drugs and collection methods must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Reflux, abdominal discomfort, diarrhea, concurrent drugs and collection methods is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N29 · Are pregnancy outcomes and long-term maternal/fetal safety answered?

Required materials and conditions: Pregnancy outcomes, miscarriage, long-term maternal/fetal follow-up and denominators
Conditions for verification: Original material and analysis scope on Pregnancy outcomes, miscarriage, long-term maternal/fetal follow-up and denominators must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Pregnancy outcomes, miscarriage, long-term maternal/fetal follow-up and denominators is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N30 · What level of information do references to ACOG, NCCIH and EMA provide?

Required materials and conditions: Actual agency-specific wording, products and dose material
Conditions for verification: Original material and analysis scope on Actual agency-specific wording, products and dose material must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Actual agency-specific wording, products and dose material is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N31 · Can findings extend to vomiting frequency, admission or hyperemesis treatment?

Required materials and conditions: Direct comparisons and null findings for other endpoints
Conditions for verification: Original material and analysis scope on Direct comparisons and null findings for other endpoints must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Direct comparisons and null findings for other endpoints is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N32 · How are English wording and historical corrections retained?

Required materials and conditions: Current Korean/English wording and the English placeholder correction of 2026-09-14
Conditions for verification: Original material and analysis scope on Current Korean/English wording and the English placeholder correction of 2026-09-14 must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Current Korean/English wording and the English placeholder correction of 2026-09-14 is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N33 · How are the C score of 50, axes and historical independent cross-check retained?

Required materials and conditions: Historical preservation of the original grade, score, axes, verdict date and previous verification wording
Conditions for verification: Original material and analysis scope on Historical preservation of the original grade, score, axes, verdict date and previous verification wording must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Historical preservation of the original grade, score, axes, verdict date and previous verification wording is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

N34 · What was actually read, and what do the dates mean?

Required materials and conditions: Distinction between the stored record and external-paper, registration and planning material read
Conditions for verification: Original material and analysis scope on Distinction between the stored record and external-paper, registration and planning material read must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Why this condition is needed: Material on Distinction between the stored record and external-paper, registration and planning material read is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

What the statuses mean

Partly verified: Partial information from the stored summary is linked; detailed originals and content review remain incomplete.
Unverified: Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.
Review incomplete: Review of existing content remains incomplete.
Met: This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.
Not reported: Unreported within material actually read. Unread external material is not relabeled as unreported.
Inaccessible: This means actual access failure. External access was not attempted in this work, so this state was not assigned.
Not applicable: Used only with an application exception and reason based on the question scope.
Conflicting data: This requires actual comparison of materials; no new conflict judgment was made in this work.
Insufficient evidence for the conditions: This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade.

Change history

2026-10-25 · Public page/material version 1.0

The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which early-pregnancy nausea question does the table cover?

Current findings: The original claim is reduced nausea severity in early pregnancy. Vomiting frequency, admission and pregnancy outcomes remain separate.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Detailed eligibility and the clinical endpoint hierarchy in the external original trial remain unread.
Required materials and conditions: The comparison boundary for nausea severity between oral Zintoma capsules and placebo
Materials to obtain first: Original-trial eligibility/endpoint tables and prespecified plans
Further research: Material needed: Original-trial eligibility/endpoint tables and prespecified plans. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on The comparison boundary for nausea severity between oral Zintoma capsules and placebo must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on The comparison boundary for nausea severity between oral Zintoma capsules and placebo is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01 S02

N02 · Which pregnant population is represented?

Current findings: The retained population is women with singleton pregnancies before 16 weeks and mild or moderate nausea/vomiting.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Recruitment route, age, excluded conditions, baseline risk and detailed eligibility remain unverified.
Required materials and conditions: Eligibility for singleton pregnancy before 16 weeks with mild or moderate nausea/vomiting
Materials to obtain first: Recruitment/eligibility tables and baseline characteristics
Further research: Material needed: Recruitment/eligibility tables and baseline characteristics. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Eligibility for singleton pregnancy before 16 weeks with mild or moderate nausea/vomiting must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Eligibility for singleton pregnancy before 16 weeks with mild or moderate nausea/vomiting is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N03 · Is this the same treatment question as hyperemesis gravidarum?

Current findings: The original record states that findings cannot be extended to replacement of hyperemesis treatment.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Direct comparisons for dehydration, admission or severe hyperemesis are not established in the retained summary.
Required materials and conditions: Distinction between mild/moderate nausea and severe hyperemesis gravidarum
Materials to obtain first: Severity definitions and hyperemesis-comparison results
Further research: Material needed: Severity definitions and hyperemesis-comparison results. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Distinction between mild/moderate nausea and severe hyperemesis gravidarum must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Distinction between mild/moderate nausea and severe hyperemesis gravidarum is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N04 · Is the ginger formulation and product the same?

Current findings: The retained product is Zintoma 250 mg capsules; gingerol/shogaol assays and extraction methods remain unverified.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Batch, standardization, assay and extraction material are absent.
Required materials and conditions: Manufacturing, extraction and ingredient assays for Zintoma 250 mg capsules
Materials to obtain first: Product/batch and ingredient-analysis material
Further research: Material needed: Product/batch and ingredient-analysis material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Manufacturing, extraction and ingredient assays for Zintoma 250 mg capsules must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Manufacturing, extraction and ingredient assays for Zintoma 250 mg capsules is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N05 · What is the intervention route?

Current findings: The selected route is oral. The original record limits interchangeability among foods, powders, standardized extracts, oils, topical products and combinations.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Effects of other routes/formulations are not established by this material.
Required materials and conditions: Distinction between oral capsules and foods, oils, topical products and combinations
Materials to obtain first: Intervention-administration records
Further research: Material needed: Intervention-administration records. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Distinction between oral capsules and foods, oils, topical products and combinations must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Distinction between oral capsules and foods, oils, topical products and combinations is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N06 · What were the dose and intake frequency?

Current findings: The retained dose is 250 mg, 3 times daily, totaling 750 mg/day.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Actual intake, adherence and dose-change records remain unverified.
Required materials and conditions: Actual administration/adherence for 250 mg, 3 times daily, with a total of 750 mg/day
Materials to obtain first: Administration and medication-adherence records
Further research: Material needed: Administration and medication-adherence records. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Actual administration/adherence for 250 mg, 3 times daily, with a total of 750 mg/day must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Actual administration/adherence for 250 mg, 3 times daily, with a total of 750 mg/day is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N07 · Are duration and measurement times distinguished?

Current findings: The retained intervention description records treatment over 4 days.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Daily measurement schedules, persistence after treatment and longer follow-up remain unverified.
Required materials and conditions: Treatment over 4 days and the nausea-measurement schedule
Materials to obtain first: Visit schedules and endpoint-measurement tables
Further research: Material needed: Visit schedules and endpoint-measurement tables. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Treatment over 4 days and the nausea-measurement schedule must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Treatment over 4 days and the nausea-measurement schedule is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N08 · What was the common dietary advice in the placebo comparison?

Current findings: The comparator is recorded as the same dietary advice and lactose placebo capsules.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Adherence to dietary advice and group-specific use of other or rescue treatment remain unverified.
Required materials and conditions: A comparison retaining the same dietary advice and lactose placebo
Materials to obtain first: Dietary-advice, concurrent-treatment and rescue-treatment records
Further research: Material needed: Dietary-advice, concurrent-treatment and rescue-treatment records. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on A comparison retaining the same dietary advice and lactose placebo must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on A comparison retaining the same dietary advice and lactose placebo is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N09 · How is the direct report identified?

Current findings: The retained bibliography records Saberi 2014, PMID 25414888, PMCID PMC4228518 and DOI 10.17795/nmsjournal11841.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Current external bibliography, identity of the original file and full text remain unread.
Required materials and conditions: Retained links among the Saberi report title, PMID, PMCID and DOI
Materials to obtain first: Original paper and bibliographic record
Further research: Material needed: Original paper and bibliographic record. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Retained links among the Saberi report title, PMID, PMCID and DOI must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Retained links among the Saberi report title, PMID, PMCID and DOI is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N10 · Do a registration number and registration content have the same verification level?

Current findings: The bibliography contains IRCT201103192699N4, while registration status in the original record remains unverified.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: The registration document, timing, change history and correspondence with the original trial remain unread.
Required materials and conditions: Bibliographic IRCT201103192699N4 wording and the actual registration document
Materials to obtain first: Original registration and its history
Further research: Material needed: Original registration and its history. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Bibliographic IRCT201103192699N4 wording and the actual registration document must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Bibliographic IRCT201103192699N4 wording and the actual registration document is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N11 · Was the nausea-only endpoint prespecified?

Current findings: The original record states that the prespecified hierarchy for the selected nausea-only endpoint was insufficient.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Whether it was a single primary endpoint (1st in the hierarchy), subscore selection and the multiple-endpoint plan remain unverified.
Required materials and conditions: Prespecified hierarchy, analysis and timing of the Rhodes nausea subscore
Materials to obtain first: Protocol, statistical analysis plan and registered endpoints
Further research: Material needed: Protocol, statistical analysis plan and registered endpoints. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Prespecified hierarchy, analysis and timing of the Rhodes nausea subscore must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Prespecified hierarchy, analysis and timing of the Rhodes nausea subscore is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N12 · How was 3-arm randomization performed?

Current findings: The direct report is retained as a 3-arm randomized placebo-controlled trial.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Sequence generation, allocation concealment and detailed allocation across all 3 arms remain unverified.
Required materials and conditions: Allocation sequence, concealment, arm definitions and recruitment flow
Materials to obtain first: Allocation methods and arm-specific participant flow
Further research: Material needed: Allocation methods and arm-specific participant flow. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Allocation sequence, concealment, arm definitions and recruitment flow must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Allocation sequence, concealment, arm definitions and recruitment flow is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N13 · Were blinding and a similar placebo maintained?

Current findings: The summary includes placebo capsules and the same dietary advice.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Ginger taste/smell, placebo matching, assessor blinding and unblinding remain unverified.
Required materials and conditions: Participant/assessor blinding and sensory placebo matching
Materials to obtain first: Placebo composition, blinding methods and unblinding records
Further research: Material needed: Placebo composition, blinding methods and unblinding records. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Participant/assessor blinding and sensory placebo matching must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Participant/assessor blinding and sensory placebo matching is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N14 · What were the overall 3-arm and main-analysis denominators?

Current findings: The retained denominators are 120 allocated and 106 in the main analysis.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Arm-specific allocation/analysis denominators and analysis-population definitions remain unverified in detail.
Required materials and conditions: Distinction between 120 allocated and 106 in the main analysis overall
Materials to obtain first: Arm-specific flow diagrams and analysis-population definitions
Further research: Material needed: Arm-specific flow diagrams and analysis-population definitions. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Distinction between 120 allocated and 106 in the main analysis overall must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Distinction between 120 allocated and 106 in the main analysis overall is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N15 · What were the denominators of the selected direct comparison?

Current findings: The retained direct comparison has 80 allocated and 73 analyzed. These are not added to the overall 120 and 106.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Individual denominators of the two comparison arms and correspondence with analysis counts absent from the original record remain unverified.
Required materials and conditions: Distinction between 80 allocated/73 analyzed in the direct comparison and all 3 arms
Materials to obtain first: Arm-specific allocated/analyzed counts for the selected comparison
Further research: Material needed: Arm-specific allocated/analyzed counts for the selected comparison. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Distinction between 80 allocated/73 analyzed in the direct comparison and all 3 arms must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Distinction between 80 allocated/73 analyzed in the direct comparison and all 3 arms is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N16 · What were the losses to observation and analysis assumptions?

Current findings: The current summary distinguishes allocated participants from those in the main analysis.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Withdrawal reasons, arm-specific losses, missing-data handling and ITT status remain unverified. Differences in counts are not newly calculated.
Required materials and conditions: Withdrawal reasons, missing-data handling, ITT and adherence analyses
Materials to obtain first: Withdrawal, missing-data handling and analysis plans
Further research: Material needed: Withdrawal, missing-data handling and analysis plans. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Withdrawal reasons, missing-data handling, ITT and adherence analyses must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Withdrawal reasons, missing-data handling, ITT and adherence analyses is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N17 · How was the Rhodes subscore measured?

Current findings: The selected endpoint is change in the Rhodes nausea subscore.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Scale range, original definition of score direction, assessor, baseline and daily times remain unverified in detail.
Required materials and conditions: Nausea-subscore scale, direction, baseline and measurement times
Materials to obtain first: Scale/questionnaire, baseline and measurement tables
Further research: Material needed: Scale/questionnaire, baseline and measurement tables. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Nausea-subscore scale, direction, baseline and measurement times must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Nausea-subscore scale, direction, baseline and measurement times is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N18 · What do reductions of 3.86 and 1.26 mean?

Current findings: The retained result is a reduction of 3.86±2.35 versus 1.26±1.57. These values are recorded unchanged without creating a new difference.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: The statistical definition of ±, arm mapping in the original table and the exact between-group change estimate remain unverified.
Required materials and conditions: Arm-specific reductions, spread values and arm mapping
Materials to obtain first: Original result tables and analysis output
Further research: Material needed: Original result tables and analysis output. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Arm-specific reductions, spread values and arm mapping must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Arm-specific reductions, spread values and arm mapping is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N19 · Is P=.001 the test of the selected two arms?

Current findings: The original P=.001 is retained as coming from the 3-arm ANOVA.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: The exact pairwise P value for the selected two arms and multiple-comparison adjustment remain unverified.
Required materials and conditions: Distinction between the 3-arm ANOVA and pairwise-comparison P values
Materials to obtain first: 3-arm/pairwise analysis tables and analysis plans
Further research: Material needed: 3-arm/pairwise analysis tables and analysis plans. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Distinction between the 3-arm ANOVA and pairwise-comparison P values must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Distinction between the 3-arm ANOVA and pairwise-comparison P values is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N20 · Is an exact interval available for the pairwise effect?

Current findings: The current summary leaves the exact pairwise CI unverified.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: The between-group estimate and 95% CI are absent. No new CI is calculated from retained means, spread values or denominators.
Required materials and conditions: Effect estimate and confidence interval for the selected direct comparison
Materials to obtain first: Original tables of between-group estimates and 95% CIs
Further research: Material needed: Original tables of between-group estimates and 95% CIs. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Effect estimate and confidence interval for the selected direct comparison must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Effect estimate and confidence interval for the selected direct comparison is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N21 · Is the score difference clinically important?

Current findings: The retained material describes a signal of improved nausea scores.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Important-difference/responder criteria and perceived change for the Rhodes nausea subscore remain unverified.
Required materials and conditions: Minimum important difference, responder criteria and patient-important outcomes
Materials to obtain first: Important-difference evidence and responder results
Further research: Material needed: Important-difference evidence and responder results. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Minimum important difference, responder criteria and patient-important outcomes must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Minimum important difference, responder criteria and patient-important outcomes is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N22 · Which comparison does the pooled meta-analysis result represent?

Current findings: The retained meta-analysis records 13 studies with 1,174 people and nausea versus placebo with SMD 0.821, 95% CI 0.585~1.056 and I²=38.9%.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Exact sign conventions for effect direction, inclusion tables, models, subgroup analyses and product-specific values remain unread in the original paper.
Required materials and conditions: The 13 studies with 1,174 people and SMD for nausea severity versus placebo
Materials to obtain first: Original meta-analysis, inclusion tables and pooled models
Further research: Material needed: Original meta-analysis, inclusion tables and pooled models. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on The 13 studies with 1,174 people and SMD for nausea severity versus placebo must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on The 13 studies with 1,174 people and SMD for nausea severity versus placebo is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S02

N23 · Is the vitamin B6 comparison the same as placebo?

Current findings: The original record and meta-analysis summary record a null result against B6, distinguished from improvement versus placebo.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: B6 doses, comparison-specific estimates/CIs and equivalence/noninferiority designs remain unverified.
Required materials and conditions: Separation of active-comparator B6 and placebo comparisons
Materials to obtain first: Comparator-specific results and B6 administration conditions
Further research: Material needed: Comparator-specific results and B6 administration conditions. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Separation of active-comparator B6 and placebo comparisons must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Separation of active-comparator B6 and placebo comparisons is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S02

N24 · How varied were formulations, doses and scales across pooled trials?

Current findings: The original record describes varied formulations, doses, scales and quality across included trials and retains I²=38.9%.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Product-specific heterogeneity and a separate pooled estimate for the selected Zintoma conditions remain unverified.
Required materials and conditions: I² and variation in formulations, doses, scales and methodology
Materials to obtain first: Trial-specific formulation, dose, scale and methods tables
Further research: Material needed: Trial-specific formulation, dose, scale and methods tables. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on I² and variation in formulations, doses, scales and methodology must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on I² and variation in formulations, doses, scales and methodology is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S02

N25 · Are the same original trials counted repeatedly?

Current findings: The original record states that meta-analyses share many original trials. Direct-trial and pooled denominators are not added.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Exact inclusion relationships between these reports, shared-trial lists with other reviews and unique trial/participant counts remain unverified.
Required materials and conditions: Relationships among reports, trials and meta-analysis inclusion
Materials to obtain first: Report-trial mapping and included-trial lists
Further research: Material needed: Report-trial mapping and included-trial lists. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Relationships among reports, trials and meta-analysis inclusion must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Relationships among reports, trials and meta-analysis inclusion is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01 S02

N26 · What scope of information does university funding provide?

Current findings: The retained direct-trial funding is Kashan University grant 8614. The meta-analysis is recorded as having university affiliations and mixed original-trial funding.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Details of funding contracts and roles in design, analysis and publication remain unverified.
Required materials and conditions: Kashan University grant 8614 and research-funding relationships
Materials to obtain first: Funding statements, contracts and research-role disclosures
Further research: Material needed: Funding statements, contracts and research-role disclosures. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Kashan University grant 8614 and research-funding relationships must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Kashan University grant 8614 and research-funding relationships is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01 S02

N27 · Are product supply, employee authors and COI separately verified?

Current findings: University grant wording and generic English funding wording are retained.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Specific material on product supply, manufacturer involvement, employee authorship and declared COI remains separately unverified.
Required materials and conditions: Free product support, company roles, employee authorship and conflicts beyond funding
Materials to obtain first: Original product-support, affiliation and COI statements
Further research: Material needed: Original product-support, affiliation and COI statements. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Free product support, company roles, employee authorship and conflicts beyond funding must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Free product support, company roles, employee authorship and conflicts beyond funding is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01 S02

N28 · How were short-term discomfort and drug interactions recorded?

Current findings: The retained safety description notes caution about acid reflux, abdominal discomfort, diarrhea and possible drug interactions.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Arm-specific adverse-event counts, event definitions, collection methods and concurrent-drug records in the direct trial remain unverified.
Required materials and conditions: Reflux, abdominal discomfort, diarrhea, concurrent drugs and collection methods
Materials to obtain first: Adverse-event tables, collection methods and concurrent-drug records
Further research: Material needed: Adverse-event tables, collection methods and concurrent-drug records. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Reflux, abdominal discomfort, diarrhea, concurrent drugs and collection methods must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Reflux, abdominal discomfort, diarrhea, concurrent drugs and collection methods is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01

N29 · Are pregnancy outcomes and long-term maternal/fetal safety answered?

Current findings: The original record limits interpretation: nausea-score benefit does not answer long-term maternal/fetal safety.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: A summary of 4-day treatment does not provide material establishing pregnancy outcomes, rare harms or long-term risk.
Required materials and conditions: Pregnancy outcomes, miscarriage, long-term maternal/fetal follow-up and denominators
Materials to obtain first: Pregnancy-outcome and exposure/follow-up denominator material
Further research: Material needed: Pregnancy-outcome and exposure/follow-up denominator material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Pregnancy outcomes, miscarriage, long-term maternal/fetal follow-up and denominators must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Pregnancy outcomes, miscarriage, long-term maternal/fetal follow-up and denominators is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01 S02

N30 · What level of information do references to ACOG, NCCIH and EMA provide?

Current findings: The original record states that ACOG, NCCIH and EMA material was compared and summarizes NCCIH consultation advice and EMA precautionary caution.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Current agency-document versions, exact locations, products, doses and recommendation scopes remain unread in this work.
Required materials and conditions: Actual agency-specific wording, products and dose material
Materials to obtain first: Agency-document versions and original text locations
Further research: Material needed: Agency-document versions and original text locations. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Actual agency-specific wording, products and dose material must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Actual agency-specific wording, products and dose material is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01 S02

N31 · Can findings extend to vomiting frequency, admission or hyperemesis treatment?

Current findings: The original record records a null pooled result for vomiting frequency and makes no claim of admission prevention or replacement of hyperemesis treatment.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: The exact pooled vomiting estimate/CI and admission/severe-treatment outcomes remain unverified from the current summary alone.
Required materials and conditions: Direct comparisons and null findings for other endpoints
Materials to obtain first: Original endpoint-specific vomiting and admission result tables
Further research: Material needed: Original endpoint-specific vomiting and admission result tables. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Direct comparisons and null findings for other endpoints must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Direct comparisons and null findings for other endpoints is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01 S02

N32 · How are English wording and historical corrections retained?

Current findings: Current English wording and the correction event for 2 fields are preserved unchanged. Some generic English wording in the original evidence summaries does not replace verification of specific values.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: The complete earlier English wording, individual fields before/after correction and correspondence with external full text are not established from this input alone.
Required materials and conditions: Current Korean/English wording and the English placeholder correction of 2026-09-14
Materials to obtain first: Original wording before/after correction and translation mapping
Further research: Material needed: Original wording before/after correction and translation mapping. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Current Korean/English wording and the English placeholder correction of 2026-09-14 must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Current Korean/English wording and the English placeholder correction of 2026-09-14 is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01 S02

N33 · How are the C score of 50, axes and historical independent cross-check retained?

Current findings: The current C score of 50, original axes and previous independent cross-check wording are original values. They are not inherited as fulfilled conditions or completed new review in this preparation.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Review of existing content remains incomplete.
Required materials and conditions: Historical preservation of the original grade, score, axes, verdict date and previous verification wording
Materials to obtain first: Additional review comments and future correction material
Further research: Material needed: Additional review comments and future correction material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Historical preservation of the original grade, score, axes, verdict date and previous verification wording must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Historical preservation of the original grade, score, axes, verdict date and previous verification wording is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01 S02

N34 · What was actually read, and what do the dates mean?

Current findings: Preparation read the complete stored summary. The original verdict date is 2026-09-08 and the correction date is 2026-09-14. External originals, registration and plans remain unread.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: No external access was attempted, so material is not labeled inaccessible or original-source verified.
Required materials and conditions: Distinction between the stored record and external-paper, registration and planning material read
Materials to obtain first: Required originals, registration, protocol and SAP material when provided
Further research: Material needed: Required originals, registration, protocol and SAP material when provided. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in product-specific directness, prespecified endpoint hierarchy, exact pairwise effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Distinction between the stored record and external-paper, registration and planning material read must link to product, dose, duration, population, placebo comparison and the nausea endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Distinction between the stored record and external-paper, registration and planning material read is needed to connect the selected product, population, common dietary advice, nausea endpoint, denominators, comparison scope or harm gaps.
Application exceptions: All-arm analysis is distinguished from the selected direct comparison, and allocation, main-analysis and direct-comparison denominators are not interchanged or added. New effects, confidence intervals or withdrawal counts are not calculated. Nausea results are not extended to vomiting, admission, replacement of hyperemesis treatment, pregnancy outcomes or long-term safety.
Referenced methods: Existing principles distinguish population, product, oral dose, duration, dietary advice, nausea endpoint, prespecified hierarchy, all-arm/selected comparisons, denominators, overlapping reports, support and harms in the retained ginger reports.

Related sources S01 S02