{ "schema_version": "chamgap-public-criteria-1.0", "title": "Zintoma Ginger 750 mg/day × Rhodes Nausea Subscore Over 4 Days in Early Pregnancy", "language": "en", "translation_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "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." }, "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ] }