{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Topical preparation from a 96%-ethanol extract of Nigella sativa seed × Reduced VASI and improved repigmentation in vitiligo",
  "language": "en",
  "translation_date": "2026-10-24",
  "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 vitiligo/VASI question is addressed?",
      "needed": "Topical ethanolic Nigella seed extract versus fish oil for VASI/repigmentation",
      "role": "Required",
      "role_reason": "Material on Topical ethanolic Nigella seed extract versus fish oil for VASI/repigmentation is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Topical ethanolic Nigella seed extract versus fish oil for VASI/repigmentation must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Specifications of formulation, population, comparator and endpoint. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Who participated and what were the baseline vitiligo characteristics?",
      "needed": "The 52 participants/adults with vitiligo, diagnosis, type and lesion distribution",
      "role": "Required",
      "role_reason": "Material on The 52 participants/adults with vitiligo, diagnosis, type and lesion distribution is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on The 52 participants/adults with vitiligo, diagnosis, type and lesion distribution must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Eligibility, baseline-characteristic and lesion-distribution material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Does the oil terminology identify the actual formulation?",
      "needed": "Ground-seed extraction with 96% ethanol, followed by solvent evaporation",
      "role": "Required",
      "role_reason": "Material on Ground-seed extraction with 96% ethanol, followed by solvent evaporation is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Ground-seed extraction with 96% ethanol, followed by solvent evaporation must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Extraction, final-composition, batch and quantification material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Are other Nigella formulations and routes distinguished?",
      "needed": "Topical skin use versus seed powder, fixed oil, aqueous extract, purified thymoquinone and combinations",
      "role": "Required",
      "role_reason": "Material on Topical skin use versus seed powder, fixed oil, aqueous extract, purified thymoquinone and combinations is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Topical skin use versus seed powder, fixed oil, aqueous extract, purified thymoquinone and combinations must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Direct comparison material separated by formulation and route. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Does the 100 g container specify the dose for 1 application?",
      "needed": "2 daily applications, the 100 g container quantity and actual use",
      "role": "Required",
      "role_reason": "Material on 2 daily applications, the 100 g container quantity and actual use is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on 2 daily applications, the 100 g container quantity and actual use must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Application, area, use-quantity and adherence records. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "How are 6 months and monthly measurements distinguished?",
      "needed": "6 months of treatment/follow-up and monthly VASI measurement",
      "role": "Required",
      "role_reason": "Material on 6 months of treatment/follow-up and monthly VASI measurement is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on 6 months of treatment/follow-up and monthly VASI measurement must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Monthly measurement and follow-up schedules. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Is fish oil a placebo?",
      "needed": "Composition, administration and meaning of the topical fish-oil active comparison",
      "role": "Required",
      "role_reason": "Material on Composition, administration and meaning of the topical fish-oil active comparison is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Composition, administration and meaning of the topical fish-oil active comparison must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Fish-oil, administration and shared-care specifications. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Does this comparison answer phototherapy add-on or treatment-replacement questions?",
      "needed": "The selected active comparison versus phototherapy/standard-treatment combinations",
      "role": "Required",
      "role_reason": "Material on The selected active comparison versus phototherapy/standard-treatment combinations is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on The selected active comparison versus phototherapy/standard-treatment combinations must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Concomitant-treatment, phototherapy and rescue-treatment material. 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 for the Ghorbanibirgani report, PMID, PMCID and DOI",
      "role": "Required",
      "role_reason": "Material on Retained links for the Ghorbanibirgani report, PMID, PMCID and DOI is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Retained links for the Ghorbanibirgani report, PMID, PMCID and DOI must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The direct original article and bibliographic record. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Does an IRCT number verify prospective registration?",
      "needed": "IRCT201201025069N5 and registration content, timing and history",
      "role": "Required",
      "role_reason": "Material on IRCT201201025069N5 and registration content, timing and history is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on IRCT201201025069N5 and registration content, timing and history must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Registration content, protocol and amendment history. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What are the VASI endpoint and prospective testing hierarchy?",
      "needed": "Prospective hierarchy of VASI change, monthly timepoints and body-site results",
      "role": "Required",
      "role_reason": "Material on Prospective hierarchy of VASI change, monthly timepoints and body-site results is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Prospective hierarchy of VASI change, monthly timepoints and body-site results must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Registration, protocol and SAP. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "How were randomization and concealment performed?",
      "needed": "Allocation sequence, concealment and arm-specific recruitment flow",
      "role": "Required",
      "role_reason": "Material on Allocation sequence, concealment and arm-specific recruitment flow is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Allocation sequence, concealment and arm-specific recruitment flow must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Allocation, concealment and participant-flow material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Were formulation-specific masking and assessor measurement maintained?",
      "needed": "Topical-preparation appearance/scent, participant/assessor masking and unmasking",
      "role": "Required",
      "role_reason": "Material on Topical-preparation appearance/scent, participant/assessor masking and unmasking is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Topical-preparation appearance/scent, participant/assessor masking and unmasking must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Preparation, masking and assessment methods. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Which denominators are described by 52 participants and no dropouts?",
      "needed": "Participants, arm-specific allocation, analysis, completion and lesion units",
      "role": "Required",
      "role_reason": "Material on Participants, arm-specific allocation, analysis, completion and lesion units is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Participants, arm-specific allocation, analysis, completion and lesion units must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Arm-specific flow, endpoint denominators and lesion-analysis material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What are the missing-data rules and repeated-measures model assumptions?",
      "needed": "Monthly repeated measurement, missingness, ITT, clustering and adjusted models",
      "role": "Required",
      "role_reason": "Material on Monthly repeated measurement, missingness, ITT, clustering and adjusted models is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Monthly repeated measurement, missingness, ITT, clustering and adjusted models must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: SAP, repeated-measures and missing-data analysis material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "How is VASI calculated and interpreted?",
      "needed": "VASI calculation, baseline body sites, assessors and repigmentation interpretation",
      "role": "Required",
      "role_reason": "Material on VASI calculation, baseline body sites, assessors and repigmentation interpretation is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on VASI calculation, baseline body sites, assessors and repigmentation interpretation must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: VASI methods, baseline lesions and assessment material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "What are the before/after VASI values in each arm?",
      "needed": "Nigella/fish-oil means and variation values with arm correspondence",
      "role": "Required",
      "role_reason": "Material on Nigella/fish-oil means and variation values with arm correspondence is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Nigella/fish-oil means and variation values with arm correspondence must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original arm-specific VASI tables, denominators and analysis definitions. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Which test does P<.020 at months 4–6 refer to?",
      "needed": "Monthly between-group results, prospective testing and exact timepoints",
      "role": "Required",
      "role_reason": "Material on Monthly between-group results, prospective testing and exact timepoints is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Monthly between-group results, prospective testing and exact timepoints must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Monthly repeated measurement, between-group tests and SAP. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Is the exact 6-month between-group effect and interval available?",
      "needed": "The 6-month between-group estimate, 95% CI and effect type",
      "role": "Required",
      "role_reason": "Material on The 6-month between-group estimate, 95% CI and effect type is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on The 6-month between-group estimate, 95% CI and effect type must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The 6-month between-group estimate, 95% CI and model output. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Was multiplicity across body sites and timepoints addressed?",
      "needed": "Body-site/monthly tests, multiplicity and selective reporting",
      "role": "Required",
      "role_reason": "Material on Body-site/monthly tests, multiplicity and selective reporting is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Body-site/monthly tests, multiplicity and selective reporting must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Results for all body sites/timepoints and SAP. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Does repigmentation establish an effect at every body site?",
      "needed": "VASI, body-site effects, complete repigmentation and responders",
      "role": "Required",
      "role_reason": "Material on VASI, body-site effects, complete repigmentation and responders is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on VASI, body-site effects, complete repigmentation and responders must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Body-site, responder and repigmentation results. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Is the 33-person/47-lesion follow-up narrative independent confirmation?",
      "needed": "33 participants, 47 lesions, uncontrolled design and same-team follow-up",
      "role": "Required",
      "role_reason": "Material on 33 participants, 47 lesions, uncontrolled design and same-team follow-up is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on 33 participants, 47 lesions, uncontrolled design and same-team follow-up must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Follow-up bibliography, participant/lesion and cohort-linkage material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "What are the unique-trial/participant and independent-replication counts?",
      "needed": "Connections among the direct trial, narrative follow-up reference and multiple results",
      "role": "Required",
      "role_reason": "Material on Connections among the direct trial, narrative follow-up reference and multiple results is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Connections among the direct trial, narrative follow-up reference and multiple results must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: A report–trial–cohort–lesion linkage table. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Does no specific funding mean independent funding?",
      "needed": "The no-specific-research-funding statement versus actual funding and roles",
      "role": "Required",
      "role_reason": "Material on The no-specific-research-funding statement versus actual funding and roles is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on The no-specific-research-funding statement versus actual funding and roles must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Research-funding, role and cost disclosures. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Does a Giah Essence preparation establish product support or employee authorship?",
      "needed": "Manufacturer, product provision, author employment and conflicts",
      "role": "Required",
      "role_reason": "Material on Manufacturer, product provision, author employment and conflicts is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Manufacturer, product provision, author employment and conflicts must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original product-support, author-affiliation and conflict disclosures. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "How were topical adverse events collected?",
      "needed": "Skin reactions, event definitions, arm-specific collection and exposure denominators",
      "role": "Supplementary",
      "role_reason": "Material on Skin reactions, event definitions, arm-specific collection and exposure denominators is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Skin reactions, event definitions, arm-specific collection and exposure denominators must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Skin-event, collection and exposure-denominator material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are extraction methods, product composition and safety interchangeable?",
      "needed": "Product, extraction, constituent quantities and skin-exposure differences",
      "role": "Supplementary",
      "role_reason": "Material on Product, extraction, constituent quantities and skin-exposure differences is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Product, extraction, constituent quantities and skin-exposure differences must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Formulation, constituent-quantity, exposure and safety material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Are vulnerable groups, concomitant medicines and longer-term harms answered?",
      "needed": "Pregnancy, breastfeeding, children, liver/kidney conditions, concomitant medicines and perioperative use",
      "role": "Supplementary",
      "role_reason": "Material on Pregnancy, breastfeeding, children, liver/kidney conditions, concomitant medicines and perioperative use is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Pregnancy, breastfeeding, children, liver/kidney conditions, concomitant medicines and perioperative use must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Vulnerable-group, concomitant-medicine and longer-term harm material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Can this be extended to standard-treatment replacement, pure oil or creams?",
      "needed": "The selected ethanolic topical extract versus other products and treatment replacement",
      "role": "Required",
      "role_reason": "Material on The selected ethanolic topical extract versus other products and treatment replacement is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on The selected ethanolic topical extract versus other products and treatment replacement must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Direct comparisons of replacement, combinations and other formulations. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "What are the current Korean/English wording and English correction?",
      "needed": "Current Korean/English wording, the 1-field correction and generic English evidence wording",
      "role": "Required",
      "role_reason": "Material on Current Korean/English wording, the 1-field correction and generic English evidence wording is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Current Korean/English wording, the 1-field correction and generic English evidence wording must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Before/after correction and language-correspondence material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "What are the original C/46, axes and historical cross-checking?",
      "needed": "C/46, EX/CX, all original axes and historical cross-checking",
      "role": "Required",
      "role_reason": "Material on C/46, EX/CX, all original axes and historical cross-checking is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on C/46, EX/CX, all original axes and historical cross-checking must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Feedback and future correction material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What are the dates, empty records and actual reading scope?",
      "needed": "Original evidence/correction dates, empty original values and stored-summary/external-unread scope",
      "role": "Required",
      "role_reason": "Material on Original evidence/correction dates, empty original values and stored-summary/external-unread scope is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.",
      "application_exception": "Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.",
      "criterion": "Original records on Original evidence/correction dates, empty original values and stored-summary/external-unread scope must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.",
      "condition_origin": "These existing conditions are linked to the stored vitiligo record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Needed original material and extraction/denominator/timepoint material when supplied. This records needed materials; no new research was executed."
    }
  ]
}