# Topical preparation from a 96%-ethanol extract of Nigella sativa seed × Reduced VASI and improved repigmentation in vitiligo

Verdict 3036 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-09-08  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-24

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: The retained record describes 52 participants/adults with vitiligo. Diagnosis, type, activity, baseline lesions, eligibility/exclusions and arm-specific randomized/analysis denominators remain incompletely verified. Participants and lesion counts remain distinct.
- Ingredient, formulation and route: The topical preparation used ground Nigella sativa L. seeds extracted with 96% ethanol, followed by solvent evaporation. The article's oil terminology is not made interchangeable with simply pressed oil, pure fixed oil, creams, oral preparations, purified thymoquinone or combinations. Final composition, residual solvent, batches and quantification remain unverified.
- Dose: The original record describes 2 applications to lesions daily. The 100 g quantity describes the container; the dose for 1 application, per-area amount, actual use, cumulative exposure and adherence remain unverified. Container quantity is not converted into a daily or recommended dose.
- Comparator: The comparator is topical fish oil, an active comparator rather than placebo. Composition, application, shared care, sensory matching and concomitant standard treatment/changes remain unverified. Within-group changes do not establish a placebo-controlled effect or replacement of standard treatment.
- Measured outcome: The endpoint is VASI change with monthly repeated measurement. Scale calculation, body-site contributions, assessor reliability, prospective principal endpoint/timepoint, multiplicity, patient importance, responders and complete repigmentation remain separately unverified.
- Duration: The original record describes 6 months of treatment/follow-up. Detailed monthly schedules, persistence after treatment, relapse and longer follow-up remain unverified. The duration is not converted into another period or presented as establishing persistent effects.
- Questions outside this scope: The selected question compares topical ethanolic seed extract with active fish oil for VASI/repigmentation in vitiligo. Other formulations, routes, placebo comparisons, phototherapy combinations and standard-treatment replacement are different questions.; The original C/46/Caution and B/P/R1/I1/EX/B2/CX are retained. Uncertainty is not converted into absence of effects, and historical cross-checking is not presented as current content review, formal-method execution or independent clinical validation.; The 96% value describes the ethanol used for seed extraction, with solvent evaporation recorded in the original. The 2 daily applications and 100 g container are retained; application, cumulative, daily and recommended doses are not newly calculated.; The original VASI values, 4.98±4.81→3.75±3.91 versus 4.98±4.80→4.62±4.36, are retained. The definition of ± and arm-specific analysis denominators remain unverified. Changes, between-group differences, percentages and effect intervals are not newly calculated.; The retained between-group P<.020 at months 4–6 is not converted into an exact 6-month effect, 95% CI or prospective testing hierarchy. Monthly/site-specific results remain distinct from complete/every-site repigmentation, responders and clinical importance.; The 52 participants and no-dropout statement are retained original descriptions. Arm-specific randomization, analysis, lesion units, missingness and harm denominators remain unverified. The later 33-person/47-lesion uncontrolled, same-team narrative is unlinked to the original bibliography and is not made into a new report, independent replication or participant total.; PMID25068060, PMCID PMC4102993, DOI10.5812/ircmj.4515 and IRCT201201025069N5 are identifiers in the existing bibliography. The registration number is not promoted to actual registration reading or verified prespecification; articles, plans and support disclosures remain unread.; The original evidence date 2026-09-08, correction of 1 English-placeholder field on 2026-09-14 and production date 2026-10-06 remain distinct. Generic English verification/funding wording and precautions are not inherited as current original-source reading, independence, harm collection or overall-safety certification.

## Checklist items

### N01 · Which vitiligo/VASI question is addressed?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The original claim concerns reduced VASI and improved repigmentation in vitiligo. Its scope is an active-control comparison of topical ethanolic seed extract.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Placebo-controlled effects, standard-treatment replacement and direct effects of other products remain unverified.
- Required materials and conditions: Topical ethanolic Nigella seed extract versus fish oil for VASI/repigmentation
- Materials to obtain first: Specifications of formulation, population, comparator and endpoint
- Further research: Material needed: Specifications of formulation, population, comparator and endpoint. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N02 · Who participated and what were the baseline vitiligo characteristics?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained use conditions describe 52 participants/adults with vitiligo.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Detailed diagnosis, disease type/activity, history, baseline lesion distribution and exclusions remain unverified.
- Required materials and conditions: The 52 participants/adults with vitiligo, diagnosis, type and lesion distribution
- Materials to obtain first: Eligibility, baseline-characteristic and lesion-distribution material
- Further research: Material needed: Eligibility, baseline-characteristic and lesion-distribution material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N03 · Does the oil terminology identify the actual formulation?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained manuscript describes the article's oil preparation as a 96% ethanolic seed extract, rather than simply pressed oil.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Detailed final composition, residual solvent, extraction yield, quantification and batches remain unverified.
- Required materials and conditions: Ground-seed extraction with 96% ethanol, followed by solvent evaporation
- Materials to obtain first: Extraction, final-composition, batch and quantification material
- Further research: Material needed: Extraction, final-composition, batch and quantification material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N04 · Are other Nigella formulations and routes distinguished?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The selected route is topical skin application. The original restricts interchangeability among other Nigella formulations, purified constituents and combinations.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Equivalent effects of other formulations/routes remain unverified.
- Required materials and conditions: Topical skin use versus seed powder, fixed oil, aqueous extract, purified thymoquinone and combinations
- Materials to obtain first: Direct comparison material separated by formulation and route
- Further research: Material needed: Direct comparison material separated by formulation and route. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N05 · Does the 100 g container specify the dose for 1 application?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained dose description is 2 applications to lesions daily; 100 g is the container quantity, and the dose for 1 application is unverified.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: The dose for 1 application, per-area application, actual use, cumulative exposure and adherence remain unverified. Container quantity is not converted into a daily dose.
- Required materials and conditions: 2 daily applications, the 100 g container quantity and actual use
- Materials to obtain first: Application, area, use-quantity and adherence records
- Further research: Material needed: Application, area, use-quantity and adherence records. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N06 · How are 6 months and monthly measurements distinguished?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained duration is 6 months, with VASI described as monthly repeated measurement.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Detailed measurement schedules, post-treatment persistence, relapse and longer follow-up remain unverified.
- Required materials and conditions: 6 months of treatment/follow-up and monthly VASI measurement
- Materials to obtain first: Monthly measurement and follow-up schedules
- Further research: Material needed: Monthly measurement and follow-up schedules. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N07 · Is fish oil a placebo?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained comparator is topical fish oil, an active comparator. Within-group changes in both arms are not converted into a placebo-controlled effect.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Detailed comparator composition, dose, matched application/shared care and the meaning of active control remain unverified.
- Required materials and conditions: Composition, administration and meaning of the topical fish-oil active comparison
- Materials to obtain first: Fish-oil, administration and shared-care specifications
- Further research: Material needed: Fish-oil, administration and shared-care specifications. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N08 · Does this comparison answer phototherapy add-on or treatment-replacement questions?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The original distinguishes this preparation from pure oil, creams and standard-phototherapy combinations.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Use/changes of concomitant standard treatment and direct treatment-replacement comparisons remain unverified.
- Required materials and conditions: The selected active comparison versus phototherapy/standard-treatment combinations
- Materials to obtain first: Concomitant-treatment, phototherapy and rescue-treatment material
- Further research: Material needed: Concomitant-treatment, phototherapy and rescue-treatment material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N09 · How is the direct report identified?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained bibliography records the 2014 report, PMID 25068060, PMCID PMC4102993 and DOI 10.5812/ircmj.4515.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Current external bibliographic material, article files and full text remain unread in this work.
- Required materials and conditions: Retained links for the Ghorbanibirgani report, PMID, PMCID and DOI
- Materials to obtain first: The direct original article and bibliographic record
- Further research: Material needed: The direct original article and bibliographic record. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N10 · Does an IRCT number verify prospective registration?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained evidence-table registration field and bibliography record IRCT201201025069N5. The identifier is not promoted to actual registration reading.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Registration content, prospective timing, amendments and endpoint correspondence remain unread.
- Required materials and conditions: IRCT201201025069N5 and registration content, timing and history
- Materials to obtain first: Registration content, protocol and amendment history
- Further research: Material needed: Registration content, protocol and amendment history. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N11 · What are the VASI endpoint and prospective testing hierarchy?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The original marks the exact 6-month between-group effect, 95% CI and prospective testing hierarchy as unverified.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: A single prospective primary endpoint, timepoint, body-site/test hierarchy and multiplicity plan remain unverified.
- Required materials and conditions: Prospective hierarchy of VASI change, monthly timepoints and body-site results
- Materials to obtain first: Registration, protocol and SAP
- Further research: Material needed: Registration, protocol and SAP. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N12 · How were randomization and concealment performed?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained design description is a randomized, double-blind, active-controlled trial.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Detailed sequence generation, concealment, arm-specific recruitment and eligibility application remain unverified.
- Required materials and conditions: Allocation sequence, concealment and arm-specific recruitment flow
- Materials to obtain first: Allocation, concealment and participant-flow material
- Further research: Material needed: Allocation, concealment and participant-flow material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N13 · Were formulation-specific masking and assessor measurement maintained?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The report is retained as describing double blinding.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Detailed sensory matching, who was masked, unmasking and VASI-assessor procedures remain unverified.
- Required materials and conditions: Topical-preparation appearance/scent, participant/assessor masking and unmasking
- Materials to obtain first: Preparation, masking and assessment methods
- Further research: Material needed: Preparation, masking and assessment methods. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N14 · Which denominators are described by 52 participants and no dropouts?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained sample description is 52 participants with no dropouts. Participant and lesion counts are not interchanged.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Detailed arm-specific allocation, VASI analysis counts, analysis-population definitions and lesion-clustering treatment remain unverified.
- Required materials and conditions: Participants, arm-specific allocation, analysis, completion and lesion units
- Materials to obtain first: Arm-specific flow, endpoint denominators and lesion-analysis material
- Further research: Material needed: Arm-specific flow, endpoint denominators and lesion-analysis material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N15 · What are the missing-data rules and repeated-measures model assumptions?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The original describes repeated-measures analysis as reporting differences at months 4–6.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Missing-data handling, ITT, correlation structure, lesion clustering, adjustment variables and model assumptions remain unverified.
- Required materials and conditions: Monthly repeated measurement, missingness, ITT, clustering and adjusted models
- Materials to obtain first: SAP, repeated-measures and missing-data analysis material
- Further research: Material needed: SAP, repeated-measures and missing-data analysis material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N16 · How is VASI calculated and interpreted?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The selected endpoint is VASI change, recorded as monthly repeated measurement.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Detailed scale calculation, body-site contributions, assessor reliability and repigmentation interpretation remain unverified.
- Required materials and conditions: VASI calculation, baseline body sites, assessors and repigmentation interpretation
- Materials to obtain first: VASI methods, baseline lesions and assessment material
- Further research: Material needed: VASI methods, baseline lesions and assessment material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N17 · What are the before/after VASI values in each arm?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained result is 4.98±4.81→3.75±3.91 versus 4.98±4.80→4.62±4.36. Order and values are retained.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: The statistical meaning of ±, original tables, arm-specific denominators and exact between-group change remain unverified. Within-group and between-group differences are not newly calculated.
- Required materials and conditions: Nigella/fish-oil means and variation values with arm correspondence
- Materials to obtain first: Original arm-specific VASI tables, denominators and analysis definitions
- Further research: Material needed: Original arm-specific VASI tables, denominators and analysis definitions. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N18 · Which test does P<.020 at months 4–6 refer to?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained result is between-group P<.020 at months 4–6. The original describes reported differences from month 4 onward.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Exact monthly tests, P values, adjustment and prospective hierarchy remain unverified.
- Required materials and conditions: Monthly between-group results, prospective testing and exact timepoints
- Materials to obtain first: Monthly repeated measurement, between-group tests and SAP
- Further research: Material needed: Monthly repeated measurement, between-group tests and SAP. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N19 · Is the exact 6-month between-group effect and interval available?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The original marks the exact 6-month between-group effect and 95% CI as unverified.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Between-group estimates, intervals and adjusted models are absent from the retained material. No new CI is calculated from retained means, variation values or the 52 participants.
- Required materials and conditions: The 6-month between-group estimate, 95% CI and effect type
- Materials to obtain first: The 6-month between-group estimate, 95% CI and model output
- Further research: Material needed: The 6-month between-group estimate, 95% CI and model output. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N20 · Was multiplicity across body sites and timepoints addressed?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The original records multiplicity concerns across body-site tests and timepoints.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: The full set of tests, adjustment, prospective hierarchy and unreported results remain unverified.
- Required materials and conditions: Body-site/monthly tests, multiplicity and selective reporting
- Materials to obtain first: Results for all body sites/timepoints and SAP
- Further research: Material needed: Results for all body sites/timepoints and SAP. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N21 · Does repigmentation establish an effect at every body site?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The original states that complete repigmentation and efficacy at every body site were not established.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Exact site-specific effects, responder criteria, complete-repigmentation denominators and CIs remain unverified.
- Required materials and conditions: VASI, body-site effects, complete repigmentation and responders
- Materials to obtain first: Body-site, responder and repigmentation results
- Further research: Material needed: Body-site, responder and repigmentation results. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N22 · Is the 33-person/47-lesion follow-up narrative independent confirmation?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The original supplementary summary describes the 33-person/47-lesion follow-up as uncontrolled and from the same team, and did not count it as independent confirmation. The current bibliography identifies the direct trial, rather than linking the follow-up report.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: The follow-up report title/bibliography, exact formulation, original-cohort overlap and lesion analysis remain unverified in this input.
- Required materials and conditions: 33 participants, 47 lesions, uncontrolled design and same-team follow-up
- Materials to obtain first: Follow-up bibliography, participant/lesion and cohort-linkage material
- Further research: Material needed: Follow-up bibliography, participant/lesion and cohort-linkage material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N23 · What are the unique-trial/participant and independent-replication counts?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The direct active-control report remains distinct from the narrative follow-up reference. The 52 participants, 33 participants and 47 lesions are not newly summed into participant totals or independent replication.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Exact report–trial–cohort relationships, unique participants and independent-replication counts remain unverified.
- Required materials and conditions: Connections among the direct trial, narrative follow-up reference and multiple results
- Materials to obtain first: A report–trial–cohort–lesion linkage table
- Further research: Material needed: A report–trial–cohort–lesion linkage table. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N24 · Does no specific funding mean independent funding?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained funding description reports no specific research funding; the original restricts claims of independently funded strengths as unverified.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Funding sources, cost coverage and design/analysis/publication roles remain unverified.
- Required materials and conditions: The no-specific-research-funding statement versus actual funding and roles
- Materials to obtain first: Research-funding, role and cost disclosures
- Further research: Material needed: Research-funding, role and cost disclosures. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N25 · Does a Giah Essence preparation establish product support or employee authorship?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained funding record names a Giah Essence Phytopharm preparation. A manufacturer name does not replace separate verification of support, employee authorship or conflicts.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Individual material on free product provision, manufacturer involvement, employee authorship and declared conflicts remains unverified.
- Required materials and conditions: Manufacturer, product provision, author employment and conflicts
- Materials to obtain first: Original product-support, author-affiliation and conflict disclosures
- Further research: Material needed: Original product-support, author-affiliation and conflict disclosures. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N26 · How were topical adverse events collected?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The original states that small trials cannot exclude rare adverse events or establish long-term safety.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Detailed skin adverse events, collection methods, arm-specific events, exposure/lesion denominators and discontinuation remain unverified.
- Required materials and conditions: Skin reactions, event definitions, arm-specific collection and exposure denominators
- Materials to obtain first: Skin-event, collection and exposure-denominator material
- Further research: Material needed: Skin-event, collection and exposure-denominator material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N27 · Are extraction methods, product composition and safety interchangeable?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The original states that constituent quantities can vary by product and extraction method.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Product-specific constituents, skin exposure, longer-term events and safety correspondence with other formulations remain unverified.
- Required materials and conditions: Product, extraction, constituent quantities and skin-exposure differences
- Materials to obtain first: Formulation, constituent-quantity, exposure and safety material
- Further research: Material needed: Formulation, constituent-quantity, exposure and safety material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N28 · Are vulnerable groups, concomitant medicines and longer-term harms answered?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained safety wording records precautions for the relevant vulnerable-group/concomitant-medicine situations and limitations of long-term safety evidence.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Direct event comparisons, longer follow-up and exposure denominators by population and concomitant medicine remain unverified.
- Required materials and conditions: Pregnancy, breastfeeding, children, liver/kidney conditions, concomitant medicines and perioperative use
- Materials to obtain first: Vulnerable-group, concomitant-medicine and longer-term harm material
- Further research: Material needed: Vulnerable-group, concomitant-medicine and longer-term harm material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N29 · Can this be extended to standard-treatment replacement, pure oil or creams?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The original restricts standard-treatment replacement, pure oil, creams and phototherapy combinations as different questions.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Direct comparison effects for standard-treatment replacement and other products remain unverified.
- Required materials and conditions: The selected ethanolic topical extract versus other products and treatment replacement
- Materials to obtain first: Direct comparisons of replacement, combinations and other formulations
- Further research: Material needed: Direct comparisons of replacement, combinations and other formulations. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N30 · What are the current Korean/English wording and English correction?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The current Korean/English wording and the 1-field English correction on 2026-09-14 are retained. Generic English verification wording is not inherited as current quantitative or original-source verification.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Before/after English correction texts and detailed original-source correspondence for individual fields remain unread.
- Required materials and conditions: Current Korean/English wording, the 1-field correction and generic English evidence wording
- Materials to obtain first: Before/after correction and language-correspondence material
- Further research: Material needed: Before/after correction and language-correspondence material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N31 · What are the original C/46, axes and historical cross-checking?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: C/46, all original axes and historical cross-check wording are preserved as historical values. Uncertainty is not regraded as no effect or inherited as newly completed content review.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Review of the retained clinical content remains incomplete.
- Required materials and conditions: C/46, EX/CX, all original axes and historical cross-checking
- Materials to obtain first: Feedback and future correction material
- Further research: Material needed: Feedback and future correction material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

### N32 · What are the dates, empty records and actual reading scope?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.

- Current findings: The retained original material was used for preparation. The original evidence date 2026-09-08, correction date 2026-09-14, empty subsidiary-claim records and empty additional discussion are retained.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: External abstracts, full texts, registration, protocols and SAPs remain unread, with no access attempt. External source links were not access-tested.
- Required materials and conditions: Original evidence/correction dates, empty original values and stored-summary/external-unread scope
- Materials to obtain first: Needed original material and extraction/denominator/timepoint material when supplied
- Further research: Material needed: Needed original material and extraction/denominator/timepoint material when supplied. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
- Referenced methods: 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.
- Related sources: S01

## Evidence and sources

### S01

2014 · Topical Nigella preparation versus fish oil in vitiligo: active-control trial

[PubMed](https://pubmed.ncbi.nlm.nih.gov/25068060/)

Materials actually read: Stored summary read; external material unread  
Findings recorded in the summary: 4.98±4.81→3.75±3.91 versus 4.98±4.80→4.62±4.36; between-group P<.020 at months 4–6  
Record level: These are existing reported values. The 52 participants/no-dropout description remains distinct from arm-specific analysis, lesion and harm denominators. Gaps remain in the definition of ±, the exact 6-month between-group effect/interval and prospective testing hierarchy. Original external material remains unread here.  
Independent replication: The direct active-control report remains distinct from a follow-up narrative unlinked to a separate bibliography. Reports, trials, teams, participants and lesions are not substituted for or added to one another; unique-trial, participant and independent-replication counts remain unrecorded.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored existing review summary | Existing stored summary acquired | Stored summary | Stored summary read | Only the stored summary/bibliography was read for preparation. This is not full-text acquisition/reading or clinical validation. Only existing bibliography is linked; external articles, abstracts, full texts, registration, protocols, analysis plans and support disclosures are unread. A URL, PMCID or registration number alone does not establish acquisition, accessibility, reading, prespecification or fulfilled conditions. The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded. |
| External article material | Original bibliography link only; external content unread | Unread; no access attempt | Unread | The original PubMed link and PMCID PMC4102993 are retained as identifiers. Acquisition, public availability, successful access and actual reading of external articles, abstracts and full texts were not verified here. Only existing bibliography is linked; external articles, abstracts, full texts, registration, protocols, analysis plans and support disclosures are unread. A URL, PMCID or registration number alone does not establish acquisition, accessibility, reading, prespecification or fulfilled conditions. The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded. |
| Registration material | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | IRCT201201025069N5 is the registration identifier in the original bibliography. Registration content, timing, amendments and endpoint correspondence were not read, and prospective registration was not certified. Only existing bibliography is linked; external articles, abstracts, full texts, registration, protocols, analysis plans and support disclosures are unread. A URL, PMCID or registration number alone does not establish acquisition, accessibility, reading, prespecification or fulfilled conditions. The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded. |
| Protocol | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | The protocol is unread. Original plans, principal endpoints, timepoints, comparisons and amendment histories were not verified. Only existing bibliography is linked; external articles, abstracts, full texts, registration, protocols, analysis plans and support disclosures are unread. A URL, PMCID or registration number alone does not establish acquisition, accessibility, reading, prespecification or fulfilled conditions. The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded. |
| Statistical analysis plan | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | Analysis plans are unread. Repeated measurement, lesion structure, missingness, multiplicity and exact between-group effects/intervals were not verified or reverse-calculated. Only existing bibliography is linked; external articles, abstracts, full texts, registration, protocols, analysis plans and support disclosures are unread. A URL, PMCID or registration number alone does not establish acquisition, accessibility, reading, prespecification or fulfilled conditions. The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded. |
| Funding, product-support and conflict material | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | The retained descriptions of no specific research funding and a Giah Essence Phytopharm preparation are preserved. Funding, product-support, employee-authorship and conflict disclosures remain separately unread. A manufacturer name does not establish independent funding, noninvolvement or overall safety. Only existing bibliography is linked; external articles, abstracts, full texts, registration, protocols, analysis plans and support disclosures are unread. A URL, PMCID or registration number alone does not establish acquisition, accessibility, reading, prespecification or fulfilled conditions. The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

## What the statuses mean

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

## Change history

2026-10-24 · Public page/materials 1.0. The public view and materials were prepared from the existing 32 items. No new clinical search, verification-state change or scoring was performed.
