{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3047-main", "verdict_number": "3047", "title": "Zintoma Ginger 750 mg/day × Rhodes Nausea Subscore Over 4 Days in Early Pregnancy", "view_version": "1.0", "view_created_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "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." }, "claim_context": { "population": "Women with singleton pregnancies before 16 weeks and mild or moderate nausea/vomiting", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which early-pregnancy nausea question does the table cover?", "needed": "The comparison boundary for nausea severity between oral Zintoma capsules and placebo", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original-trial eligibility/endpoint tables and prespecified plans. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The original claim is reduced nausea severity in early pregnancy. Vomiting frequency, admission and pregnancy outcomes remain separate.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Detailed eligibility and the clinical endpoint hierarchy in the external original trial remain unread.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original-trial eligibility/endpoint tables and prespecified plans" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which pregnant population is represented?", "needed": "Eligibility for singleton pregnancy before 16 weeks with mild or moderate nausea/vomiting", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Recruitment/eligibility tables and baseline characteristics. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The retained population is women with singleton pregnancies before 16 weeks and mild or moderate nausea/vomiting.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Recruitment route, age, excluded conditions, baseline risk and detailed eligibility remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment/eligibility tables and baseline characteristics" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Is this the same treatment question as hyperemesis gravidarum?", "needed": "Distinction between mild/moderate nausea and severe hyperemesis gravidarum", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Severity definitions and hyperemesis-comparison results. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The original record states that findings cannot be extended to replacement of hyperemesis treatment.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Direct comparisons for dehydration, admission or severe hyperemesis are not established in the retained summary.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Severity definitions and hyperemesis-comparison results" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Is the ginger formulation and product the same?", "needed": "Manufacturing, extraction and ingredient assays for Zintoma 250 mg capsules", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Product/batch and ingredient-analysis material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The retained product is Zintoma 250 mg capsules; gingerol/shogaol assays and extraction methods remain unverified.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Batch, standardization, assay and extraction material are absent.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product/batch and ingredient-analysis material" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What is the intervention route?", "needed": "Distinction between oral capsules and foods, oils, topical products and combinations", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Intervention-administration records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The selected route is oral. The original record limits interchangeability among foods, powders, standardized extracts, oils, topical products and combinations.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Effects of other routes/formulations are not established by this material.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Intervention-administration records" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What were the dose and intake frequency?", "needed": "Actual administration/adherence for 250 mg, 3 times daily, with a total of 750 mg/day", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Administration and medication-adherence records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The retained dose is 250 mg, 3 times daily, totaling 750 mg/day.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual intake, adherence and dose-change records remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Administration and medication-adherence records" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are duration and measurement times distinguished?", "needed": "Treatment over 4 days and the nausea-measurement schedule", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Visit schedules and endpoint-measurement tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The retained intervention description records treatment over 4 days.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Daily measurement schedules, persistence after treatment and longer follow-up remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit schedules and endpoint-measurement tables" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What was the common dietary advice in the placebo comparison?", "needed": "A comparison retaining the same dietary advice and lactose placebo", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Dietary-advice, concurrent-treatment and rescue-treatment records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The comparator is recorded as the same dietary advice and lactose placebo capsules.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Adherence to dietary advice and group-specific use of other or rescue treatment remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Dietary-advice, concurrent-treatment and rescue-treatment records" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How is the direct report identified?", "needed": "Retained links among the Saberi report title, PMID, PMCID and DOI", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original paper and bibliographic record. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The retained bibliography records Saberi 2014, PMID 25414888, PMCID PMC4228518 and DOI 10.17795/nmsjournal11841.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Current external bibliography, identity of the original file and full text remain unread.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original paper and bibliographic record" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Do a registration number and registration content have the same verification level?", "needed": "Bibliographic IRCT201103192699N4 wording and the actual registration document", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original registration and its history. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The bibliography contains IRCT201103192699N4, while registration status in the original record remains unverified.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "The registration document, timing, change history and correspondence with the original trial remain unread.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration and its history" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Was the nausea-only endpoint prespecified?", "needed": "Prespecified hierarchy, analysis and timing of the Rhodes nausea subscore", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Protocol, statistical analysis plan and registered endpoints. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The original record states that the prespecified hierarchy for the selected nausea-only endpoint was insufficient.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Whether it was a single primary endpoint (1st in the hierarchy), subscore selection and the multiple-endpoint plan remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocol, statistical analysis plan and registered endpoints" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "How was 3-arm randomization performed?", "needed": "Allocation sequence, concealment, arm definitions and recruitment flow", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Allocation methods and arm-specific participant flow. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The direct report is retained as a 3-arm randomized placebo-controlled trial.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Sequence generation, allocation concealment and detailed allocation across all 3 arms remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation methods and arm-specific participant flow" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Were blinding and a similar placebo maintained?", "needed": "Participant/assessor blinding and sensory placebo matching", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Placebo composition, blinding methods and unblinding records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The summary includes placebo capsules and the same dietary advice.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Ginger taste/smell, placebo matching, assessor blinding and unblinding remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo composition, blinding methods and unblinding records" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What were the overall 3-arm and main-analysis denominators?", "needed": "Distinction between 120 allocated and 106 in the main analysis overall", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific flow diagrams and analysis-population definitions. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The retained denominators are 120 allocated and 106 in the main analysis.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Arm-specific allocation/analysis denominators and analysis-population definitions remain unverified in detail.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific flow diagrams and analysis-population definitions" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What were the denominators of the selected direct comparison?", "needed": "Distinction between 80 allocated/73 analyzed in the direct comparison and all 3 arms", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific allocated/analyzed counts for the selected comparison. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The retained direct comparison has 80 allocated and 73 analyzed. These are not added to the overall 120 and 106.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Individual denominators of the two comparison arms and correspondence with analysis counts absent from the original record remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific allocated/analyzed counts for the selected comparison" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What were the losses to observation and analysis assumptions?", "needed": "Withdrawal reasons, missing-data handling, ITT and adherence analyses", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Withdrawal, missing-data handling and analysis plans. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The current summary distinguishes allocated participants from those in the main analysis.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Withdrawal reasons, arm-specific losses, missing-data handling and ITT status remain unverified. Differences in counts are not newly calculated.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Withdrawal, missing-data handling and analysis plans" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "How was the Rhodes subscore measured?", "needed": "Nausea-subscore scale, direction, baseline and measurement times", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Scale/questionnaire, baseline and measurement tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The selected endpoint is change in the Rhodes nausea subscore.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Scale range, original definition of score direction, assessor, baseline and daily times remain unverified in detail.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Scale/questionnaire, baseline and measurement tables" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What do reductions of 3.86 and 1.26 mean?", "needed": "Arm-specific reductions, spread values and arm mapping", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original result tables and analysis output. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The statistical definition of ±, arm mapping in the original table and the exact between-group change estimate remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original result tables and analysis output" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Is P=.001 the test of the selected two arms?", "needed": "Distinction between the 3-arm ANOVA and pairwise-comparison P values", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: 3-arm/pairwise analysis tables and analysis plans. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The original P=.001 is retained as coming from the 3-arm ANOVA.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The exact pairwise P value for the selected two arms and multiple-comparison adjustment remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "3-arm/pairwise analysis tables and analysis plans" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Is an exact interval available for the pairwise effect?", "needed": "Effect estimate and confidence interval for the selected direct comparison", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original tables of between-group estimates and 95% CIs. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The current summary leaves the exact pairwise CI unverified.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "The between-group estimate and 95% CI are absent. No new CI is calculated from retained means, spread values or denominators.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tables of between-group estimates and 95% CIs" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Is the score difference clinically important?", "needed": "Minimum important difference, responder criteria and patient-important outcomes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Important-difference evidence and responder results. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The retained material describes a signal of improved nausea scores.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Important-difference/responder criteria and perceived change for the Rhodes nausea subscore remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Important-difference evidence and responder results" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Which comparison does the pooled meta-analysis result represent?", "needed": "The 13 studies with 1,174 people and SMD for nausea severity versus placebo", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original meta-analysis, inclusion tables and pooled models. This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "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%.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact sign conventions for effect direction, inclusion tables, models, subgroup analyses and product-specific values remain unread in the original paper.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original meta-analysis, inclusion tables and pooled models" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Is the vitamin B6 comparison the same as placebo?", "needed": "Separation of active-comparator B6 and placebo comparisons", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Comparator-specific results and B6 administration conditions. This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The original record and meta-analysis summary record a null result against B6, distinguished from improvement versus placebo.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "B6 doses, comparison-specific estimates/CIs and equivalence/noninferiority designs remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Comparator-specific results and B6 administration conditions" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "How varied were formulations, doses and scales across pooled trials?", "needed": "I² and variation in formulations, doses, scales and methodology", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Trial-specific formulation, dose, scale and methods tables. This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The original record describes varied formulations, doses, scales and quality across included trials and retains I²=38.9%.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Product-specific heterogeneity and a separate pooled estimate for the selected Zintoma conditions remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific formulation, dose, scale and methods tables" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are the same original trials counted repeatedly?", "needed": "Relationships among reports, trials and meta-analysis inclusion", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Report-trial mapping and included-trial lists. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The original record states that meta-analyses share many original trials. Direct-trial and pooled denominators are not added.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Exact inclusion relationships between these reports, shared-trial lists with other reviews and unique trial/participant counts remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-trial mapping and included-trial lists" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What scope of information does university funding provide?", "needed": "Kashan University grant 8614 and research-funding relationships", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Funding statements, contracts and research-role disclosures. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The retained direct-trial funding is Kashan University grant 8614. The meta-analysis is recorded as having university affiliations and mixed original-trial funding.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Details of funding contracts and roles in design, analysis and publication remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding statements, contracts and research-role disclosures" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are product supply, employee authors and COI separately verified?", "needed": "Free product support, company roles, employee authorship and conflicts beyond funding", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original product-support, affiliation and COI statements. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "University grant wording and generic English funding wording are retained.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Specific material on product supply, manufacturer involvement, employee authorship and declared COI remains separately unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original product-support, affiliation and COI statements" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "How were short-term discomfort and drug interactions recorded?", "needed": "Reflux, abdominal discomfort, diarrhea, concurrent drugs and collection methods", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Adverse-event tables, collection methods and concurrent-drug records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The retained safety description notes caution about acid reflux, abdominal discomfort, diarrhea and possible drug interactions.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Arm-specific adverse-event counts, event definitions, collection methods and concurrent-drug records in the direct trial remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event tables, collection methods and concurrent-drug records" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are pregnancy outcomes and long-term maternal/fetal safety answered?", "needed": "Pregnancy outcomes, miscarriage, long-term maternal/fetal follow-up and denominators", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Pregnancy-outcome and exposure/follow-up denominator material. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The original record limits interpretation: nausea-score benefit does not answer long-term maternal/fetal safety.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "A summary of 4-day treatment does not provide material establishing pregnancy outcomes, rare harms or long-term risk.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Pregnancy-outcome and exposure/follow-up denominator material" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What level of information do references to ACOG, NCCIH and EMA provide?", "needed": "Actual agency-specific wording, products and dose material", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Agency-document versions and original text locations. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The original record states that ACOG, NCCIH and EMA material was compared and summarizes NCCIH consultation advice and EMA precautionary caution.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Current agency-document versions, exact locations, products, doses and recommendation scopes remain unread in this work.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Agency-document versions and original text locations" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Can findings extend to vomiting frequency, admission or hyperemesis treatment?", "needed": "Direct comparisons and null findings for other endpoints", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original endpoint-specific vomiting and admission result tables. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "The original record records a null pooled result for vomiting frequency and makes no claim of admission prevention or replacement of hyperemesis treatment.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The exact pooled vomiting estimate/CI and admission/severe-treatment outcomes remain unverified from the current summary alone.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original endpoint-specific vomiting and admission result tables" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "How are English wording and historical corrections retained?", "needed": "Current Korean/English wording and the English placeholder correction of 2026-09-14", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original wording before/after correction and translation mapping. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The complete earlier English wording, individual fields before/after correction and correspondence with external full text are not established from this input alone.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original wording before/after correction and translation mapping" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "How are the C score of 50, axes and historical independent cross-check retained?", "needed": "Historical preservation of the original grade, score, axes, verdict date and previous verification wording", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Additional review comments and future correction material. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Review of existing content remains incomplete.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional review comments and future correction material" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "What was actually read, and what do the dates mean?", "needed": "Distinction between the stored record and external-paper, registration and planning material read", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected Zintoma capsule and early-pregnancy nausea question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Required originals, registration, protocol and SAP material when provided. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "No external access was attempted, so material is not labeled inaccessible or original-source verified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Required originals, registration, protocol and SAP material when provided" } ], "reports": [ { "report_id": "S01", "title": "Saberi et al. (2014): Effect of Ginger on Relieving Nausea and Vomiting in Pregnancy: A Randomized, Placebo-Controlled Trial", "url": "https://pubmed.ncbi.nlm.nih.gov/25414888/", "report_type": "Report of a 3-arm randomized placebo-controlled trial", "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "Stored summary and bibliography read; external paper, registration and planning material unread", "study_family": "Direct Zintoma trial and the selected two-arm comparison", "independent_replication": "The stored direct report is not used as new certification of independent replication.", "observed_result": "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.", "result_level": "Reductions and all-arm test in a stored summary; exact pairwise effect unverified", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Existing stored summary acquired", "access_status": "Stored summary", "acquired": true, "actually_read": "Stored summary read", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "External article, abstract and full text", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Registration material", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Protocol", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Statistical analysis plan (SAP)", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Funding, product-support and conflict material", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/25414888/" } ] }, { "report_id": "S02", "title": "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", "url": "https://pubmed.ncbi.nlm.nih.gov/31937153/", "report_type": "Report of a meta-analysis of randomized trials", "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "Stored summary and bibliography read; external paper, registration and planning material unread", "study_family": "Pooled report across varying ginger conditions; distinguished from product-specific direct replication", "independent_replication": "Pooled values with unverified overlap and product-specific conditions are not certified as independent replication of the selected product.", "observed_result": "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.", "result_level": "Retained pooled nausea result and active-comparator boundary; not a product-specific effect", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Existing stored summary acquired", "access_status": "Stored summary", "acquired": true, "actually_read": "Stored summary read", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "External article, abstract and full text", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Registration material", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Protocol", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Statistical analysis plan (SAP)", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Funding, product-support and conflict material", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/31937153/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-25", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-25" }