Topical berberine gelatin 5 mg/g × Reduction of pain from minor recurrent aphthous ulcers

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Evidence conditionWhich topical formulation, population and pain comparison does this checklist address?Required (claim identity)	The original claim is reduced pain from minor recurrent aphthous ulcers. The question is limited to topical 5 mg/g gelatin applied 4 times daily for 5 days versus vehicle. S01	Verification concerns the original claim identity and exclusion boundaries. It does not establish precise estimation of the pain effect or clinical confirmation.	Fixed identity of the original claim, application site/formulation/route, population, comparator, pain outcome and time.	Compare the actual intervention, population, outcome, comparator and time in subsequent documents with this question.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionAre diagnosis, eligibility and baseline characteristics of minor recurrent aphthous stomatitis verified?Required (population directness)	The original claim conditions specify adults with minor recurrent aphthous stomatitis, and the evidence table names a trial in a Chinese cohort. S01	Actual diagnostic methods, age range, baseline ulcers/pain by arm and full eligibility criteria were not verified within the retained material.	Diagnostic criteria, age, baseline ulcer/pain values, eligibility criteria and characteristics by arm.	Link eligibility criteria and baseline tables to examine whether the actual analysis population comprises adults with minor recurrent aphthous disease.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionAre the actual batch, composition and manufacturing specifications of purified berberine 5 mg/g gelatin verified?Required (intervention identity)	Gelatin containing 5 mg/g berberine is applied topically to oral ulcers. The plant source of purified berberine is unverified in the original text. S01	Original material on the actual batch, full composition/vehicle, salt form and manufacturing assays was not verified within the retained scope.	Trial-product composition, batch, salt form, manufacturing/assay records and vehicle composition.	Link product/batch documents to the actual trial product to check agreement in ingredient concentration and gelatin composition.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionAre actual amount, adherence and swallowed exposure with 4 daily applications verified?Required (actual exposure)	The original nominal frequency is 4 times daily, and the formulation concentration is 5 mg/g. S01	Actual gelatin amount per application, adherence, oral retention and swallowed exposure remain unverified. Total dose or absorption was not calculated in this work.	Amount per application, use records, returns/adherence and swallowed/retained exposure.	Link use records and administration procedures to distinguish nominal frequency from actual local exposure. Do not convert concentration into a systemic dose.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionAre vehicle composition, matching appearance and additional treatment by arm verified?Required (intervention contribution)	The comparator is vehicle gelatin without berberine, and the original design is recorded as vehicle-placebo controlled. S01	Actual material on detailed vehicle composition/appearance, oral care, rescue treatment and handling of changes by arm remains unverified.	Comparator composition/appearance, concomitant oral treatment, rescue medication and changes by arm.	Compare the vehicle product and additional treatment by arm with intervention-product/adherence records to examine differences beyond the selected ingredient.
6	Met	Full text not readStored summary read	N06 · Evidence conditionWere the original treatment and assessment time boundaries distinguished?Required (time identity)	The original duration is 5 days, with assessments on days 1, 2, 4 and 6. The evidence-table outcome is recorded as a 5-day pain score. S01	Met status applies only to distinguishing attribution of treatment and assessment records. It does not verify between-group values, denominators by assessment day or an integrated time effect.	Original records of treatment duration, assessment days and end of follow-up.	Link subsequent schedules and result tables to distinguish application duration from measurement days and attribute only verified results to their assessment times.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre random-sequence generation, allocation concealment and baseline balance verified?Required (causal comparison)	The original evidence records a randomized double-blind vehicle-placebo trial. S01	Actual sequence generation, allocation concealment and baseline balance by arm are not verified from the retained material alone.	Sequence generation, allocation concealment, recruitment/allocation procedures and baseline tables.	Link methods/allocation records to baseline tables to examine the actual allocation process and its unverified elements.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhose masking and its actual maintenance are verified?Required (subjective pain assessment)	The trial is described as a double-blind vehicle-placebo trial. S01	The actual masking targets, methods, maintenance/testing and assessor/analyst status are not specified in the retained source.	Masking targets, product distinguishability, maintenance/testing and analyst procedures.	Link methods and formulation-comparison material to examine the verified scope of actual masking targets and maintenance.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionAre the pain scale, range, direction and collection method verified?Required (outcome measurement)	The original measured outcome is pain VAS/score across assessment days, and the manuscript describes lower pain scores than vehicle. S01	The exact scale range, units, direction definition, assessors, collection procedures and time-specific between-group results remain unverified.	Scale name/range/units, assessors, collection procedures and time-specific result tables.	Link the scale description and each result table to compare pain variables/units, the meaning of lower scores and agreement in assessment conditions.
10	Unverified	Full text not readStored summary read	N10 · Evidence conditionAre analgesics, oral treatment and handling of adherence/rescue treatment by arm verified?Required (effect of interest)	The retained source describes topical gelatin versus vehicle, but does not separately provide analgesics, oral treatment or rescue-treatment handling by arm. S01	Actual co-interventions/rescue treatment/adherence by arm and their handling in the pain analysis were not verified. This does not establish nonreporting throughout the full paper.	Co-interventions/rescue treatment, adherence, changes/discontinuation and analytical handling by arm.	Link rescue-medication/co-intervention records to pain-assessment days and analysis populations to examine intervention contribution and the impact of treatment changes.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionAre 84 completers and allocation/measurement/analysis denominators by arm verified?Required (denominator attribution)	The original evidence-table sample entry states 84 completers, and the reader answer also describes an 84-completer trial. S01	Total allocation, completers by arm, measurements/analyses at each assessment and ITT/PP denominators were not verified in this work.	Allocation/measurement/completion/analysis flow and denominators by arm/assessment day.	Link participant flow and denominators in each pain-result table without transferring the 84-completer count to another analysis population.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionAre reasons for dropout/missingness and their handling in the pain analysis verified?Required (missingness/selection)	The retained source provides only 84 completers; actual allocation/dropout/missingness flow is not provided. S01	Reasons for dropout/time-specific missingness and their handling in pain analysis were not acquired. Missing-participant counts and bias magnitude were not calculated.	Dropout/missingness reasons, timing, handling and sensitivity analyses by arm.	Link participant flow to time-specific pain data to examine missingness-related selection and limitations in interpreting the effect of interest.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionAre between-arm/within-arm contrasts, analytical models and effects of interest at each assessment verified?Required (meaning of the estimate)	The manuscript describes lower pain scores than vehicle, but does not provide an exact estimate combining all follow-up days or a single prespecified primary outcome. S01	Actual time-specific contrasts, final values/changes, analysis populations and repeated-measures/adjustment models were not verified.	Contrast definitions, time-specific original results, models, ITT/PP and adjustment/repeated-measures handling.	Compare arm order, assessment time and analysis populations in pain-result tables with model descriptions to establish the actual estimated effect.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionAre the reported lower pain scores and actual time-specific between-group values verified?Required (result attribution)	The original evidence result and cited result summary retain lower scores than vehicle and P<.05. S01	Exact pain values by arm at each assessment, differences, denominators and test definitions were not verified within this retained scope.	Pain values by arm at each assessment, denominators, actual contrasts and P-test definitions.	Attribute each result to the same assessment time, scale, comparison and denominator to compare the original favorable direction with actual magnitude.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionAre between-group pain differences, variance, denominators and 95% CI verified?Required (precise effect)	The retained record describes an unreported/unverified exact between-group difference and 95% CI, retaining only lower pain scores and P<.05. S01	Only the historical bibliographic/abstract summary was read in this work; actual contrasts, variance, denominators and CI were not verified. Do not extend this limited status to nonreporting throughout the paper.	Effect, variance type, denominators, 95% CI and analytical explanations for each actual contrast.	Link original contrasts, variance, denominators and reported intervals to establish which effect the uncertainty concerns. Do not back-calculate in this work.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionAre prespecified hierarchy and multiplicity handling across outcomes and assessment days verified?Required (selective-reporting review)	The original core description distinguishes pain, size, erythema and exudation, and the rationale states that a single prespecified primary outcome is not provided. S01	Multiple outcomes are known, but actual material on a single prespecified primary outcome, assessment-day hierarchy, multiplicity and reasons for changes remains unverified.	Outcome/time hierarchy, multiplicity and reasons for changes in the protocol, registration and SAP.	Link prespecified plans and original result tables to compare pain selection/assessment times, analytical changes and multiplicity handling.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionAre a justified important difference for aphthous pain and the actual interval verified?Required (interpretation of pain magnitude)	The manuscript states that the P value alone does not establish magnitude and records that exact effects and CI were not verified. S01	A scale-appropriate important-difference basis and actual between-group effects/intervals for comparison remain unverified.	Scale-specific important-difference basis, actual contrasts/CI and patient-relevant interpretation.	Compare the important-difference basis with actual between-group estimates/intervals for the same scale, population and period to examine the interpretable scope.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionAre the actual identity and specifications of trial registration, protocol and SAP verified?Required (plan comparison)	The original registration field states that it could not be verified, and the reader answer also states that registration was not verified. S01	Actual registration/protocol/SAP identity and specifications were not acquired in the retained input. This does not establish that the trial was unregistered.	Registration number, original registration/protocol/SAP, registration date and change history.	Once identity is acquired, compare original outcomes/results/times with prespecified specifications and changes. Do not equate currently unverified registration with nonregistration.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionAre the family link for this report and other direct independent replication materials verified?Required (replication/duplication boundary)	1 evidence entry and 1 citation link Jiang 2013, PMID 23246229 and DOI 10.1016/j.oooo.2012.09.009; the original manuscript describes one trial and unverified independent replication. S01	Retained report identity is verified, but comparison of unique families through registration/recruitment cohorts and actual material on other direct independent replications remains unverified.	Report/trial-family map, registration links and identity of replication material for the same question.	Compare the relationships among PMID/DOI/registration, recruitment cohorts and assessment times to distinguish repeat citations from independent replication. Do not conduct a new exhaustive search or sum participants.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre all assessment times and null or unfavorable results for the same pain question verified?Required (result selection)	The retained summary describes lower pain scores/P<.05 and a consistent direction, but does not provide all time-specific values. S01	The summary read in this work does not verify all null/unfavorable pain results or the scope of selective reporting.	Complete pain-result tables, assessment times/denominators, supplementary material and selection criteria.	Compare all pain results by assessment time, scale and contrast to examine favorable-result selection without treating different outcomes as conflicts.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionAre government support, product provision, author employment and full COI material verified?Required (comparison with original independence records)	The original funding record describes Chinese non-US government research support and unverified product/COI details. S01	Actual funding details, product provision, author-specific employment/COI and design/analysis control remain unverified.	Funding details, product provision, author employment/disclosures and design/analysis roles.	Link funding, product and author documents to design/analysis roles to examine actual disclosure levels and remaining uncertainty.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre the short-term report on 84 people, actual safety denominators, event definitions and collection verified?Supplementary; required for safety claims	The original safety explanation states that no obvious adverse effects occurred in a short trial involving 84 people. S01	Actual exposure/safety denominators, event counts by arm, diagnosis/collection and detailed dropout/discontinuation information remain unverified. Do not convert this to 0 total events in 84 people.	All exposed/safety denominators, event/person counts by arm, collection methods and discontinuation reasons.	Link exposure by arm with safety tables/collection procedures to compare the scope of the completer-sample description with all actually exposed participants.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionAre actual irritation, allergy and swallowed-exposure events, timing and alternative explanations verified?Supplementary; required for the relevant harm	The original safety statement records that safety concerning local irritation, allergy and swallowed exposure is not established. S01	This input lacks actual person/event counts, exposure/timing, discontinuation/recovery and baseline/co-intervention material for those events; risk magnitude and causality were not verified.	Irritation/allergy/swallowing events, exposure amount/timing, baseline/co-interventions and discontinuation/recovery.	Link event records to actual local/swallowed exposure, timing and alternative explanations/comparators to examine the scope of what can be said.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionAre pregnancy/lactation and safety/interaction materials beyond short follow-up verified?Supplementary; required for expanded safety	The original safety explanation specifies that pregnancy/lactation safety is not established; the trial is short term at 5 days. S01	Direct material on these vulnerable populations, long-term/repeated exposure and interactions was not checked in this work. No new personal-use instructions are created.	Direct exposure, events, duration and concomitant-use/interaction material by population.	Compare vulnerable-population/repeated-exposure material by formulation, route, population and follow-up, separating it from short-term general-adult material.
25	Met	Full text not readStored summary read	N25 · Evidence conditionWere the pain effect and safety limitations retained as separate records?Required (description boundary)	Lower pain scores than vehicle/P<.05 are retained separately from the original Caution label and unverified local irritation, allergy, swallowing, pregnancy and lactation. S01	Met status is limited to separating attribution of efficacy and safety records. Actual harm-material criteria remain unverified/partly verified.	Links among pain observations, original safety text, denominators/duration and interpretation boundaries.	When subsequent efficacy/safety material arrives, compare outcome, denominator, period and actual reading scope separately and update the relevant links.
26	Not applicable	Full text not readStored summary read	N26 · Evidence conditionDoes this checklist additionally require verification of optimal dosing or long-term persistence?Supplementary; required for the relevant extension	The original scope is pain with topical 5 mg/g gelatin applied 4 times daily for 5 days. Optimal concentration/frequency and long-term persistence were not selected claims. S01	Do not add optimal dosing or long-term persistence as mandatory extensions to the original claim. This does not establish lack of such effects or complete absence of material.	For an extension claim: direct concentration/dose comparisons and long-term/withdrawal material.	If that extension is separately requested, examine designs comparing concentration/frequency and withdrawal/long-term results using the same pain definition.
27	Not applicable	Full text not readStored summary read	N27 · Evidence conditionDoes the same effect question include size, erythema, exudation, healing, recurrence or infection treatment?Supplementary; required for a separate outcome	The original core description distinguishes four outcomes, and the advertising-limit text restricts extensions to cure, recurrence prevention, infection treatment and oral-systemic effects. S01	These are not direct outcomes of the selected pain question. Nonapplicability does not establish an effect of 0 on other outcomes or worldwide absence of healing/recurrence material.	For an extension: direct outcome definitions, comparisons, denominators, periods and results.	When separately examining an extension, design analyses separating its prespecified definition, direct results, denominators and period from pain.
28	Met	Full text not readStored summary read	N28 · Evidence conditionWere the local summary, historical bibliography/abstract checks and currently unread external material distinguished?Required (reading traceability)	The entire retained summary was actually read in this work. The manuscript records checking the PMID 23246229 bibliography/abstract, but has no individual access-date/level/location records. S01	Verification concerns material-specific actions and historical boundaries. Full paper, registration/protocol and external bibliography/abstract access were not attempted; they remain unread in this work.	Material identity, links/original locations, actual reading scope, dates and original-document SHA.	Link actual access/reading events, locations, dates and SHA for subsequent material, keeping them separate from historical access.
29	Met	Full text not readStored summary read	N29 · Evidence conditionWere the original types and records for C46, axes/flags and corrections retained?Required (original-text identity)	Original C46, B/P/R1/I1/EX/B2/CX, false flags, empty subclaim lists/text fields and the 2026-09-14 English-placeholder correction are preserved in the retained original. S01	This verifies types/original-text preservation, not current revalidation of C46 or calculation of an efficacy score or fulfilment proportion.	Original verdict, score/axes, flags, original decisions/corrections and whole-input SHA.	If changes are requested, preserve the full previous text and case/version records to compare actual differences. This work does not reassess the verdict.
30	Met	Full text not readStored summary read	N30 · Evidence conditionWere the original evidence date, current review date and scope of searches/checks distinguished?Required (scope description)	The original review date is 2026-09-08, the correction date is 2026-09-14 and the review date for the case record is 2026-10-05. No new search, full-text access, clinical calculation or reassessment is performed in this work. S01	Met status is limited to recording dates and authorized scope. It does not verify completeness of all current literature.	Original review date, case-review date, inputs used and actual search/calculation/access events.	When additional events occur, distinguish their performed scope/dates from historical records and link them to the relevant rows.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionWere original search strategies, dates, screening/exclusions and unpublished/correction-check logs acquired?Required (scope of insufficiency/absence statements)	The research-review text describes checking a PMID record/abstract and excluding oral berberine, ulcer size and healing duration. S01	That scope is described, but actual search strategies/dates, screening results/exclusion lists and unpublished/correction logs are not verified in this retained source.	Historical search strategies/dates, search results, screening/exclusions and registration/unpublished/correction-check logs.	If historical logs are acquired, compare formulation/route/population/pain eligibility with search, screening and exclusion reasons. Do not conduct a new search in this work.
32	Met	Full text not readStored summary read	N32 · Evidence conditionWere update criteria distinguishing new material from condition-version changes recorded?Required (record updates)	The checklist provides update rules distinguishing evidence additions from condition revisions and requiring actual material locations, reading, dates and SHA. S01	This is a record rule for this checklist. It does not establish completion of new clinical material, full-text reading, searches or condition updates.	Actual subsequent originals, reading/dates, locations/values/SHA, full previous versions and condition versions/reasons for changes.	Compare actual subsequent material with question eligibility, outcome/time, denominators and comparator, then review the relevant rows. Freeze a separate version before applying condition revisions.

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32 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-05
Original evidence review date: 2026-09-08
Scope actually checked: Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
Population: Adults with minor recurrent aphthous stomatitis. Actual diagnostic methods, age range, eligibility criteria and baseline ulcers and pain by arm remain unverified.
Ingredient, formulation and route: Gelatin containing 5 mg/g purified berberine was applied topically to oral ulcers. Plant source, salt form, manufacturer/batch and detailed vehicle composition remain unverified.
Dose: The nominal frequency is 4 applications daily. Gelatin amount per application, actual adherence and retained/swallowed exposure remain unverified. This is not an instruction for personal use.
Comparator: Vehicle gelatin without berberine. Detailed composition, appearance, co-interventions/rescue treatment and changes by arm remain unverified.
Measured outcome: Pain VAS/score across assessment days. The retained summary records lower pain scores than vehicle and P<.05 in an 84-completer trial. Exact between-group VAS differences, 95% CI, denominators by assessment day and prespecified hierarchy remain unverified. Retain the original C grade, 46 points and Caution.
Duration: Application lasted 5 days, with assessments recorded on days 1, 2, 4 and 6. Actual results and denominators at each assessment and persistence after treatment remain unverified.
Questions outside this scope: The ingredient name does not make oral tablets, plant extracts, other salts/derivatives, combinations or other topical formulations interchangeable.; Pain, size, erythema and exudation are separate outcomes. This checklist covers pain; do not extend it to cure, healing duration, recurrence prevention, infection treatment or oral-systemic effects.; 84 is the completed-participant count. Do not invent total allocation, arm/time-specific denominators or ITT/PP analyses. P<.05 does not establish effect size or a clinically large effect.; Retain the original Caution label and uncertainty about local irritation, allergy, swallowing, pregnancy/lactation, long-term/repeated exposure and interactions. Do not extend this to optimal application amounts, long-term persistence or personal treatment instructions.

Evidence and sources

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

S01 · Jiang 2013 report of topical berberine gelatin and aphthous-ulcer pain

PubMed

Material type: Retained bibliographic/abstract summary of a randomized double-blind vehicle-placebo trial
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Findings recorded in the stored summary: The retained summary records 84 completers, lower pain scores than vehicle and P<.05. Retain the original description of an unreported/unverified exact between-group difference and 95% CI; external full text remains unread in this work. No new calculations were performed.
Record level: A retained summary of pain as a patient-experienced outcome. Actual scale range, time-specific contrasts/denominators, variance and prespecified plans remain unverified. This is not new verification of original result tables or the reporting scope of the full paper.
Study overlap and independent replication: Evidence and citation are linked for report S01. Its PMID and DOI identify the same report rather than separate independent replications. Unique trial and participant counts and other direct independent replications remain unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Retained bilingual bibliographic/abstract summaries and historical review record	Retained copy acquired; summary read	Retained copy acquired; summary read	Stored existing review summary read	Actual values and locations in the retained summary were read. Distinguish this from external clinical full-text bytes. Historical manuscript descriptions of bibliography/abstract checks are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
PubMed bibliography/abstract entry point	Material type recorded; current public availability unverified	External access not attempted; not acquired	Not read	An entry-point link from the retained bibliography. Current URL response and bibliographic/abstract contents were not checked; access, acquisition and reading were not attempted. Historical manuscript descriptions of bibliography/abstract checks are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
Full paper: direct URL and current access scope unverified	Material type recorded; current public availability unverified	External access not attempted; not acquired	Not read	Direct full-text URL and current availability scope remain unverified. Distinguish the bibliographic entry point from full text; external access, acquisition and reading were not attempted. Historical manuscript descriptions of bibliography/abstract checks are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
Registration/protocol material type: identity unverified	Material type recorded; current public availability unverified	External access not attempted; not acquired	Not read	This identifies a needed material type. Registration number and existence of actual documents remain unverified; external access, acquisition and reading were not attempted. Historical manuscript descriptions of bibliography/abstract checks are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.

Report counts versus independent study counts

Evidence and citation are linked for report S01. Its PMID and DOI identify the same report rather than separate independent replications. Unique trial and participant counts and other direct independent replications remain unverified.

Review criteria

Version 1.0 · Criteria record date 2026-10-05. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which topical formulation, population and pain comparison does this checklist address?

Required materials and conditions: Fixed identity of the original claim, application site/formulation/route, population, comparator, pain outcome and time.
Conditions for verification: Link the original claim and exclusion boundaries for 5 mg/g berberine gelatin applied topically to oral ulcers in adults with minor recurrent aphthous disease, over 5 days, for pain versus vehicle.
Requirement and applicability: Required (claim identity)
Application exceptions: Do not automatically create separate new efficacy cases for pain, size, erythema and exudation.
Why this condition is needed: The ingredient name alone does not justify combining oral use or other ulcer outcomes.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N02 · Are diagnosis, eligibility and baseline characteristics of minor recurrent aphthous stomatitis verified?

Required materials and conditions: Diagnostic criteria, age, baseline ulcer/pain values, eligibility criteria and characteristics by arm.
Conditions for verification: Check the adult/minor recurrent aphthous population record against actual diagnostic methods, age, eligibility criteria and baseline ulcer/pain data.
Requirement and applicability: Required (population directness)
Application exceptions: Unverified eligibility criteria do not establish lack of effect in other diseases.
Why this condition is needed: Do not transfer the findings to oral ulcers of other causes, severe disease or children.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N03 · Are the actual batch, composition and manufacturing specifications of purified berberine 5 mg/g gelatin verified?

Required materials and conditions: Trial-product composition, batch, salt form, manufacturing/assay records and vehicle composition.
Conditions for verification: Compare the retained 5 mg/g berberine-gelatin, purified-ingredient and topical-route record with actual batch/salt form/vehicle composition and manufacturing specifications.
Requirement and applicability: Required (intervention identity)
Application exceptions: Do not fill the unverified plant source with an invented plant species or another salt specification.
Why this condition is needed: Do not treat botanical extracts, berberine hydrochloride tablets or derivatives as the same trial product.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N04 · Are actual amount, adherence and swallowed exposure with 4 daily applications verified?

Required materials and conditions: Amount per application, use records, returns/adherence and swallowed/retained exposure.
Conditions for verification: Check the nominal frequency of 4 daily applications against actual gelatin amount per application, adherence and retention/swallowing measurements.
Requirement and applicability: Required (actual exposure)
Application exceptions: Verification of nominal frequency does not establish an optimal application amount or a safe amount to swallow.
Why this condition is needed: Do not convert the 5 mg/g concentration into a total daily dose or systemic absorption.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N05 · Are vehicle composition, matching appearance and additional treatment by arm verified?

Required materials and conditions: Comparator composition/appearance, concomitant oral treatment, rescue medication and changes by arm.
Conditions for verification: Check the vehicle-gelatin comparator without berberine against actual composition/appearance, additional oral care and rescue-treatment material by arm.
Requirement and applicability: Required (intervention contribution)
Application exceptions: The existence of a vehicle comparator does not establish that all co-interventions were identical.
Why this condition is needed: Do not attribute vehicle effects or differences in additional treatment to berberine.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N06 · Were the original treatment and assessment time boundaries distinguished?

Required materials and conditions: Original records of treatment duration, assessment days and end of follow-up.
Conditions for verification: Distinguish the original record of 5-day application from assessments on days 1, 2, 4 and 6; do not add claims that actual results/denominators at each assessment were verified.
Requirement and applicability: Required (time identity)
Application exceptions: Actual time-specific analyses remain unverified in other rows.
Why this condition is needed: Do not turn 5-day treatment into identical analysis across all assessment days or a long-term effect.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N07 · Are random-sequence generation, allocation concealment and baseline balance verified?

Required materials and conditions: Sequence generation, allocation concealment, recruitment/allocation procedures and baseline tables.
Conditions for verification: Check the randomized vehicle-trial record against actual sequence generation, concealment and baseline-balance material by arm.
Requirement and applicability: Required (causal comparison)
Application exceptions: Do not arbitrarily relabel the design as nonrandomized because allocation details remain unverified.
Why this condition is needed: A randomized-trial label alone does not resolve allocation bias or baseline differences.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N08 · Whose masking and its actual maintenance are verified?

Required materials and conditions: Masking targets, product distinguishability, maintenance/testing and analyst procedures.
Conditions for verification: Check the double-blind record against actual masking targets among participants, clinicians, assessors and analysts, and material on maintenance/testing.
Requirement and applicability: Required (subjective pain assessment)
Application exceptions: Unverified masking does not automatically negate the pain effect.
Why this condition is needed: Do not extend the term double-blind to masking of every assessor and analyst.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N09 · Are the pain scale, range, direction and collection method verified?

Required materials and conditions: Scale name/range/units, assessors, collection procedures and time-specific result tables.
Conditions for verification: Check pain VAS/score against the actual scale range, direction, assessors, collection timing/method and measurement conditions by arm.
Requirement and applicability: Required (outcome measurement)
Application exceptions: Do not substitute ulcer size or healing duration for the pain score.
Why this condition is needed: Do not invent an exact VAS difference without a scale definition.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N10 · Are analgesics, oral treatment and handling of adherence/rescue treatment by arm verified?

Required materials and conditions: Co-interventions/rescue treatment, adherence, changes/discontinuation and analytical handling by arm.
Conditions for verification: Check actual analgesics, oral treatment, adherence, rescue treatment/discontinuation and analytical handling by arm.
Requirement and applicability: Required (effect of interest)
Application exceptions: Missing information does not mean that concomitant medication was absent.
Why this condition is needed: Differences in rescue treatment may contribute to pain differences, so actual handling material is needed.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N11 · Are 84 completers and allocation/measurement/analysis denominators by arm verified?

Required materials and conditions: Allocation/measurement/completion/analysis flow and denominators by arm/assessment day.
Conditions for verification: Check the report of 84 completers against actual separate allocation, measurement and time-specific analysis denominators by arm.
Requirement and applicability: Required (denominator attribution)
Application exceptions: Do not split 84 equally between arms or calculate 0 missing participants.
Why this condition is needed: Do not automatically substitute completers for randomized participants, ITT participants or denominators by arm.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N12 · Are reasons for dropout/missingness and their handling in the pain analysis verified?

Required materials and conditions: Dropout/missingness reasons, timing, handling and sensitivity analyses by arm.
Conditions for verification: Check actual dropout, missingness by assessment day, reasons and pain-analysis/sensitivity handling by arm.
Requirement and applicability: Required (missingness/selection)
Application exceptions: Do not fill missing flow information with complete follow-up or 0 dropouts.
Why this condition is needed: The information that 84 completed the trial does not establish absence of losses.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N13 · Are between-arm/within-arm contrasts, analytical models and effects of interest at each assessment verified?

Required materials and conditions: Contrast definitions, time-specific original results, models, ITT/PP and adjustment/repeated-measures handling.
Conditions for verification: Check actual arm order, final values/changes, between-arm/within-arm contrasts, repeated-measures models and analysis populations for each pain result.
Requirement and applicability: Required (meaning of the estimate)
Application exceptions: Do not invent ITT, change scores or time-integrated models when the original record does not identify the analysis.
Why this condition is needed: Do not turn P values or directions from multiple assessment days into one integrated between-arm change.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N14 · Are the reported lower pain scores and actual time-specific between-group values verified?

Required materials and conditions: Pain values by arm at each assessment, denominators, actual contrasts and P-test definitions.
Conditions for verification: Retain the original lower-than-vehicle/P<.05 record and check actual assessment time, arm means/changes, denominators and contrast values.
Requirement and applicability: Required (result attribution)
Application exceptions: P<.05 alone does not establish a clinically large effect, cure or confirmed replication.
Why this condition is needed: Retain the favorable direction while preserving uncertainty about effect size.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N15 · Are between-group pain differences, variance, denominators and 95% CI verified?

Required materials and conditions: Effect, variance type, denominators, 95% CI and analytical explanations for each actual contrast.
Conditions for verification: Check pain differences, SD/SE, denominators and reported 95% CI for the selected actual contrast.
Requirement and applicability: Required (precise effect)
Application exceptions: Do not invent a fixed minimum sample size or standard duration as a precision criterion.
Why this condition is needed: Neither 84 participants nor statistical significance substitutes for a precise effect.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N16 · Are prespecified hierarchy and multiplicity handling across outcomes and assessment days verified?

Required materials and conditions: Outcome/time hierarchy, multiplicity and reasons for changes in the protocol, registration and SAP.
Conditions for verification: Check the prespecified primary pain outcome, analytical hierarchy and multiplicity plans/handling among pain, size, erythema, exudation and assessment days.
Requirement and applicability: Required (selective-reporting review)
Application exceptions: Do not inherit the original false coprimary-split flag as evidence that the prespecified hierarchy of the outcomes was verified.
Why this condition is needed: Do not confuse the page’s selected pain question with the trial’s prespecified primary outcome.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N17 · Are a justified important difference for aphthous pain and the actual interval verified?

Required materials and conditions: Scale-specific important-difference basis, actual contrasts/CI and patient-relevant interpretation.
Conditions for verification: Check a justified important-difference criterion for this population/pain scale against actual between-group estimates and intervals.
Requirement and applicability: Required (interpretation of pain magnitude)
Application exceptions: Do not adopt arbitrary VAS points, fulfilment proportions or trial-count criteria.
Why this condition is needed: Do not automatically equate statistical significance with a magnitude experienced by patients.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N18 · Are the actual identity and specifications of trial registration, protocol and SAP verified?

Required materials and conditions: Registration number, original registration/protocol/SAP, registration date and change history.
Conditions for verification: Separately from the unverified registration record, check actual registration/protocol/SAP identity, dates and outcome/analysis specifications.
Requirement and applicability: Required (plan comparison)
Application exceptions: No new search or external registration access is performed in this work.
Why this condition is needed: Unverified registration number does not establish lack of a prespecified plan or confirmed selective reporting.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N19 · Are the family link for this report and other direct independent replication materials verified?

Required materials and conditions: Report/trial-family map, registration links and identity of replication material for the same question.
Conditions for verification: Check the linked Jiang report/PMID/DOI and identity/independence of other comparisons with the same formulation, population and pain outcome.
Requirement and applicability: Required (replication/duplication boundary)
Application exceptions: Do not turn absence of a search in this work or unverified replication in the original into 0 worldwide trials or an exact replication count.
Why this condition is needed: Do not count a paper and its PubMed entry point as separate independent evidence.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N20 · Are all assessment times and null or unfavorable results for the same pain question verified?

Required materials and conditions: Complete pain-result tables, assessment times/denominators, supplementary material and selection criteria.
Conditions for verification: Check actual time-specific favorable, null and unfavorable pain results, contrasts, denominators and reporting scope.
Requirement and applicability: Required (result selection)
Application exceptions: Do not automatically classify numerical differences in other ulcer outcomes as conflicting pain data.
Why this condition is needed: A favorable P-value summary does not establish the same direction for every result or absence of contrary results.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N21 · Are government support, product provision, author employment and full COI material verified?

Required materials and conditions: Funding details, product provision, author employment/disclosures and design/analysis roles.
Conditions for verification: Check the Chinese non-US government-support record against actual product provision, author employment, roles and full COI disclosures.
Requirement and applicability: Required (comparison with original independence records)
Application exceptions: Do not infer absence of bias from the original I1 label or funding name alone.
Why this condition is needed: Government-support wording does not establish absence of product/COI issues or proven independence.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N22 · Are the short-term report on 84 people, actual safety denominators, event definitions and collection verified?

Required materials and conditions: All exposed/safety denominators, event/person counts by arm, collection methods and discontinuation reasons.
Conditions for verification: Check the short-term description of no obvious adverse effects against actual separate exposed/safety denominators, event definitions, collection and discontinuation reasons by arm.
Requirement and applicability: Supplementary; required for safety claims
Application exceptions: Do not delete the retained pain observation because harm material is unverified or calculate a new incidence.
Why this condition is needed: Do not extend an absence description from short-term completers to 0 events overall or to proven safety.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N23 · Are actual irritation, allergy and swallowed-exposure events, timing and alternative explanations verified?

Required materials and conditions: Irritation/allergy/swallowing events, exposure amount/timing, baseline/co-interventions and discontinuation/recovery.
Conditions for verification: Check event definitions, exposure/onset, discontinuation/recovery, concurrent exposure and comparisons, distinguishing signal, frequency and causality.
Requirement and applicability: Supplementary; required for the relevant harm
Application exceptions: Missing event material does not establish that irritation or allergy did not occur.
Why this condition is needed: Do not turn unverified safety issues into observed events or confirmed causality.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N24 · Are pregnancy/lactation and safety/interaction materials beyond short follow-up verified?

Required materials and conditions: Direct exposure, events, duration and concomitant-use/interaction material by population.
Conditions for verification: Check direct exposure/event/comparison material on pregnancy, lactation, long-term/repeated application and concomitant medication.
Requirement and applicability: Supplementary; required for expanded safety
Application exceptions: Do not require every rare-harm study as a mandatory effect criterion for the original pain question.
Why this condition is needed: Do not extend 5-day general-adult material to pregnancy/lactation or overall long-term safety.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N25 · Were the pain effect and safety limitations retained as separate records?

Required materials and conditions: Links among pain observations, original safety text, denominators/duration and interpretation boundaries.
Conditions for verification: Link the original pain observation/P value and Caution/safety gaps separately; do not inherit efficacy reporting as safety verification.
Requirement and applicability: Required (description boundary)
Application exceptions: Meeting this record-separation criterion does not establish safety concerning irritation/allergy or pregnancy/lactation.
Why this condition is needed: A favorable efficacy direction must not erase safety gaps.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N26 · Does this checklist additionally require verification of optimal dosing or long-term persistence?

Required materials and conditions: For an extension claim: direct concentration/dose comparisons and long-term/withdrawal material.
Conditions for verification: Do not add optimal concentration/frequency, long-term persistence or withdrawal effects as mandatory confirmation beyond the selected 5 mg/g, 4-times-daily, 5-day scope.
Requirement and applicability: Supplementary; required for the relevant extension
Application exceptions: Actual nominal/application amount is covered in a separate row; unverified optimal amounts do not establish safe amounts.
Why this condition is needed: Do not combine the narrow pain question with every dose-finding or persistence study.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N27 · Does the same effect question include size, erythema, exudation, healing, recurrence or infection treatment?

Required materials and conditions: For an extension: direct outcome definitions, comparisons, denominators, periods and results.
Conditions for verification: Separate the selected pain outcome from size/erythema/exudation, healing duration, recurrence and infection treatment; do not add those extensions as mandatory outcomes here.
Requirement and applicability: Supplementary; required for a separate outcome
Application exceptions: Retain other outcome observations, but do not invent values/effects absent from the retained source.
Why this condition is needed: Do not extend a significant symptom score to cure or preventive effects.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N28 · Were the local summary, historical bibliography/abstract checks and currently unread external material distinguished?

Required materials and conditions: Material identity, links/original locations, actual reading scope, dates and original-document SHA.
Conditions for verification: Distinguish actual reading of the retained summary, the historical bibliography/abstract-check narrative, absent individual access records and external access not attempted/unread in this work.
Requirement and applicability: Required (reading traceability)
Application exceptions: Do not assign inaccessible status to external material when access was not attempted.
Why this condition is needed: A PubMed link or an original bibliography/abstract-check statement does not establish full-text reading in this work.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N29 · Were the original types and records for C46, axes/flags and corrections retained?

Required materials and conditions: Original verdict, score/axes, flags, original decisions/corrections and whole-input SHA.
Conditions for verification: Link grade C, score 46, original axes/false flags, empty strings/arrays, grade decisions and corrections/dates to the exact input; do not inherit them as new condition scores.
Requirement and applicability: Required (original-text identity)
Application exceptions: Do not fill absent grade-revalidation, evidence-status or access fields with false values or new verification claims.
Why this condition is needed: Do not confuse the earlier clinical verdict with preparation of the current evidence checklist.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N30 · Were the original evidence date, current review date and scope of searches/checks distinguished?

Required materials and conditions: Original review date, case-review date, inputs used and actual search/calculation/access events.
Conditions for verification: Link the original review date with the case-review date, inputs used and the record of 0 new searches, calculations or external accesses in this work.
Requirement and applicability: Required (scope description)
Application exceptions: Do not invent an original evidence-cutoff field or claim that it was the same field as the recorded review date.
Why this condition is needed: Do not turn the original evidence date into a date claiming completion of a current exhaustive literature search.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N31 · Were original search strategies, dates, screening/exclusions and unpublished/correction-check logs acquired?

Required materials and conditions: Historical search strategies/dates, search results, screening/exclusions and registration/unpublished/correction-check logs.
Conditions for verification: Beyond the bibliography/abstract checks and oral/other-outcome exclusions, check actual search strategies/dates, results/screening and unpublished/registration/correction logs.
Requirement and applicability: Required (scope of insufficiency/absence statements)
Application exceptions: Unverified logs do not establish 0 human studies, 0 effect or 0 retractions.
Why this condition is needed: Reading a retained abstract does not establish verification of all clinical literature.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N32 · Were update criteria distinguishing new material from condition-version changes recorded?

Required materials and conditions: Actual subsequent originals, reading/dates, locations/values/SHA, full previous versions and condition versions/reasons for changes.
Conditions for verification: Provide rules recording evidence additions with actual identity/reading/locations/values/SHA separately from revisions of the question or criteria.
Requirement and applicability: Required (record updates)
Application exceptions: Recording this update rule does not perform subsequent checks, reassessment or deployment.
Why this condition is needed: Material additions or display changes must not automatically become clinical confirmation.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Referenced methods and the sections actually reviewed

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

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

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

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

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

Referenced principle: Link studies and reports separately; do not omit studies solely because results are unreported.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

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

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

Referenced principle: Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

What the statuses mean

Met: The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety.
Partly verified: Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing.
Unverified: The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access.
Not applicable: Used only with a reason that an item is outside the actual scope of the selected question. It does not replace unverified or unread status.
Not reported: Nonreporting is limited to a specific material or section actually read. This work did not assign a reporting status to the entire full paper.
Inaccessible: Used only for an actual access failure. Distinguish it from external access not attempted in this work.

Change history

2026-10-27 · Public page/material version 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.

The stored-material review date (2026-10-05) and original evidence review date (2026-09-08) were retained unchanged.

Researcher downloads

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

View all item details

N01 · Which topical formulation, population and pain comparison does this checklist address?

Current findings: The original claim is reduced pain from minor recurrent aphthous ulcers. The question is limited to topical 5 mg/g gelatin applied 4 times daily for 5 days versus vehicle.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Verification concerns the original claim identity and exclusion boundaries. It does not establish precise estimation of the pain effect or clinical confirmation.
Reason for missing information: Verification concerns the original claim identity and exclusion boundaries. It does not establish precise estimation of the pain effect or clinical confirmation.
Required materials and conditions: Fixed identity of the original claim, application site/formulation/route, population, comparator, pain outcome and time.
Materials to obtain first: Fixed identity of the original claim, application site/formulation/route, population, comparator, pain outcome and time.
Further research: Compare the actual intervention, population, outcome, comparator and time in subsequent documents with this question.
Remaining uncertainty: Verification concerns the original claim identity and exclusion boundaries. It does not establish precise estimation of the pain effect or clinical confirmation.
Conditions for verification: Link the original claim and exclusion boundaries for 5 mg/g berberine gelatin applied topically to oral ulcers in adults with minor recurrent aphthous disease, over 5 days, for pain versus vehicle.
Why this condition is needed: The ingredient name alone does not justify combining oral use or other ulcer outcomes.
Application exceptions: Do not automatically create separate new efficacy cases for pain, size, erythema and exudation.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N02 · Are diagnosis, eligibility and baseline characteristics of minor recurrent aphthous stomatitis verified?

Current findings: The original claim conditions specify adults with minor recurrent aphthous stomatitis, and the evidence table names a trial in a Chinese cohort.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Actual diagnostic methods, age range, baseline ulcers/pain by arm and full eligibility criteria were not verified within the retained material.
Reason for missing information: Actual diagnostic methods, age range, baseline ulcers/pain by arm and full eligibility criteria were not verified within the retained material.
Required materials and conditions: Diagnostic criteria, age, baseline ulcer/pain values, eligibility criteria and characteristics by arm.
Materials to obtain first: Diagnostic criteria, age, baseline ulcer/pain values, eligibility criteria and characteristics by arm.
Further research: Link eligibility criteria and baseline tables to examine whether the actual analysis population comprises adults with minor recurrent aphthous disease.
Remaining uncertainty: Actual diagnostic methods, age range, baseline ulcers/pain by arm and full eligibility criteria were not verified within the retained material.
Conditions for verification: Check the adult/minor recurrent aphthous population record against actual diagnostic methods, age, eligibility criteria and baseline ulcer/pain data.
Why this condition is needed: Do not transfer the findings to oral ulcers of other causes, severe disease or children.
Application exceptions: Unverified eligibility criteria do not establish lack of effect in other diseases.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N03 · Are the actual batch, composition and manufacturing specifications of purified berberine 5 mg/g gelatin verified?

Current findings: Gelatin containing 5 mg/g berberine is applied topically to oral ulcers. The plant source of purified berberine is unverified in the original text.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Original material on the actual batch, full composition/vehicle, salt form and manufacturing assays was not verified within the retained scope.
Reason for missing information: Original material on the actual batch, full composition/vehicle, salt form and manufacturing assays was not verified within the retained scope.
Required materials and conditions: Trial-product composition, batch, salt form, manufacturing/assay records and vehicle composition.
Materials to obtain first: Trial-product composition, batch, salt form, manufacturing/assay records and vehicle composition.
Further research: Link product/batch documents to the actual trial product to check agreement in ingredient concentration and gelatin composition.
Remaining uncertainty: Original material on the actual batch, full composition/vehicle, salt form and manufacturing assays was not verified within the retained scope.
Conditions for verification: Compare the retained 5 mg/g berberine-gelatin, purified-ingredient and topical-route record with actual batch/salt form/vehicle composition and manufacturing specifications.
Why this condition is needed: Do not treat botanical extracts, berberine hydrochloride tablets or derivatives as the same trial product.
Application exceptions: Do not fill the unverified plant source with an invented plant species or another salt specification.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N04 · Are actual amount, adherence and swallowed exposure with 4 daily applications verified?

Current findings: The original nominal frequency is 4 times daily, and the formulation concentration is 5 mg/g.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Actual gelatin amount per application, adherence, oral retention and swallowed exposure remain unverified. Total dose or absorption was not calculated in this work.
Reason for missing information: Actual gelatin amount per application, adherence, oral retention and swallowed exposure remain unverified. Total dose or absorption was not calculated in this work.
Required materials and conditions: Amount per application, use records, returns/adherence and swallowed/retained exposure.
Materials to obtain first: Amount per application, use records, returns/adherence and swallowed/retained exposure.
Further research: Link use records and administration procedures to distinguish nominal frequency from actual local exposure. Do not convert concentration into a systemic dose.
Remaining uncertainty: Actual gelatin amount per application, adherence, oral retention and swallowed exposure remain unverified. Total dose or absorption was not calculated in this work.
Conditions for verification: Check the nominal frequency of 4 daily applications against actual gelatin amount per application, adherence and retention/swallowing measurements.
Why this condition is needed: Do not convert the 5 mg/g concentration into a total daily dose or systemic absorption.
Application exceptions: Verification of nominal frequency does not establish an optimal application amount or a safe amount to swallow.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N05 · Are vehicle composition, matching appearance and additional treatment by arm verified?

Current findings: The comparator is vehicle gelatin without berberine, and the original design is recorded as vehicle-placebo controlled.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Actual material on detailed vehicle composition/appearance, oral care, rescue treatment and handling of changes by arm remains unverified.
Reason for missing information: Actual material on detailed vehicle composition/appearance, oral care, rescue treatment and handling of changes by arm remains unverified.
Required materials and conditions: Comparator composition/appearance, concomitant oral treatment, rescue medication and changes by arm.
Materials to obtain first: Comparator composition/appearance, concomitant oral treatment, rescue medication and changes by arm.
Further research: Compare the vehicle product and additional treatment by arm with intervention-product/adherence records to examine differences beyond the selected ingredient.
Remaining uncertainty: Actual material on detailed vehicle composition/appearance, oral care, rescue treatment and handling of changes by arm remains unverified.
Conditions for verification: Check the vehicle-gelatin comparator without berberine against actual composition/appearance, additional oral care and rescue-treatment material by arm.
Why this condition is needed: Do not attribute vehicle effects or differences in additional treatment to berberine.
Application exceptions: The existence of a vehicle comparator does not establish that all co-interventions were identical.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N06 · Were the original treatment and assessment time boundaries distinguished?

Current findings: The original duration is 5 days, with assessments on days 1, 2, 4 and 6. The evidence-table outcome is recorded as a 5-day pain score.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Met status applies only to distinguishing attribution of treatment and assessment records. It does not verify between-group values, denominators by assessment day or an integrated time effect.
Reason for missing information: Met status applies only to distinguishing attribution of treatment and assessment records. It does not verify between-group values, denominators by assessment day or an integrated time effect.
Required materials and conditions: Original records of treatment duration, assessment days and end of follow-up.
Materials to obtain first: Original records of treatment duration, assessment days and end of follow-up.
Further research: Link subsequent schedules and result tables to distinguish application duration from measurement days and attribute only verified results to their assessment times.
Remaining uncertainty: Met status applies only to distinguishing attribution of treatment and assessment records. It does not verify between-group values, denominators by assessment day or an integrated time effect.
Conditions for verification: Distinguish the original record of 5-day application from assessments on days 1, 2, 4 and 6; do not add claims that actual results/denominators at each assessment were verified.
Why this condition is needed: Do not turn 5-day treatment into identical analysis across all assessment days or a long-term effect.
Application exceptions: Actual time-specific analyses remain unverified in other rows.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N07 · Are random-sequence generation, allocation concealment and baseline balance verified?

Current findings: The original evidence records a randomized double-blind vehicle-placebo trial.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Actual sequence generation, allocation concealment and baseline balance by arm are not verified from the retained material alone.
Reason for missing information: Actual sequence generation, allocation concealment and baseline balance by arm are not verified from the retained material alone.
Required materials and conditions: Sequence generation, allocation concealment, recruitment/allocation procedures and baseline tables.
Materials to obtain first: Sequence generation, allocation concealment, recruitment/allocation procedures and baseline tables.
Further research: Link methods/allocation records to baseline tables to examine the actual allocation process and its unverified elements.
Remaining uncertainty: Actual sequence generation, allocation concealment and baseline balance by arm are not verified from the retained material alone.
Conditions for verification: Check the randomized vehicle-trial record against actual sequence generation, concealment and baseline-balance material by arm.
Why this condition is needed: A randomized-trial label alone does not resolve allocation bias or baseline differences.
Application exceptions: Do not arbitrarily relabel the design as nonrandomized because allocation details remain unverified.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N08 · Whose masking and its actual maintenance are verified?

Current findings: The trial is described as a double-blind vehicle-placebo trial.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The actual masking targets, methods, maintenance/testing and assessor/analyst status are not specified in the retained source.
Reason for missing information: The actual masking targets, methods, maintenance/testing and assessor/analyst status are not specified in the retained source.
Required materials and conditions: Masking targets, product distinguishability, maintenance/testing and analyst procedures.
Materials to obtain first: Masking targets, product distinguishability, maintenance/testing and analyst procedures.
Further research: Link methods and formulation-comparison material to examine the verified scope of actual masking targets and maintenance.
Remaining uncertainty: The actual masking targets, methods, maintenance/testing and assessor/analyst status are not specified in the retained source.
Conditions for verification: Check the double-blind record against actual masking targets among participants, clinicians, assessors and analysts, and material on maintenance/testing.
Why this condition is needed: Do not extend the term double-blind to masking of every assessor and analyst.
Application exceptions: Unverified masking does not automatically negate the pain effect.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N09 · Are the pain scale, range, direction and collection method verified?

Current findings: The original measured outcome is pain VAS/score across assessment days, and the manuscript describes lower pain scores than vehicle.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The exact scale range, units, direction definition, assessors, collection procedures and time-specific between-group results remain unverified.
Reason for missing information: The exact scale range, units, direction definition, assessors, collection procedures and time-specific between-group results remain unverified.
Required materials and conditions: Scale name/range/units, assessors, collection procedures and time-specific result tables.
Materials to obtain first: Scale name/range/units, assessors, collection procedures and time-specific result tables.
Further research: Link the scale description and each result table to compare pain variables/units, the meaning of lower scores and agreement in assessment conditions.
Remaining uncertainty: The exact scale range, units, direction definition, assessors, collection procedures and time-specific between-group results remain unverified.
Conditions for verification: Check pain VAS/score against the actual scale range, direction, assessors, collection timing/method and measurement conditions by arm.
Why this condition is needed: Do not invent an exact VAS difference without a scale definition.
Application exceptions: Do not substitute ulcer size or healing duration for the pain score.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N10 · Are analgesics, oral treatment and handling of adherence/rescue treatment by arm verified?

Current findings: The retained source describes topical gelatin versus vehicle, but does not separately provide analgesics, oral treatment or rescue-treatment handling by arm.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Actual co-interventions/rescue treatment/adherence by arm and their handling in the pain analysis were not verified. This does not establish nonreporting throughout the full paper.
Reason for missing information: Actual co-interventions/rescue treatment/adherence by arm and their handling in the pain analysis were not verified. This does not establish nonreporting throughout the full paper.
Required materials and conditions: Co-interventions/rescue treatment, adherence, changes/discontinuation and analytical handling by arm.
Materials to obtain first: Co-interventions/rescue treatment, adherence, changes/discontinuation and analytical handling by arm.
Further research: Link rescue-medication/co-intervention records to pain-assessment days and analysis populations to examine intervention contribution and the impact of treatment changes.
Remaining uncertainty: Actual co-interventions/rescue treatment/adherence by arm and their handling in the pain analysis were not verified. This does not establish nonreporting throughout the full paper.
Conditions for verification: Check actual analgesics, oral treatment, adherence, rescue treatment/discontinuation and analytical handling by arm.
Why this condition is needed: Differences in rescue treatment may contribute to pain differences, so actual handling material is needed.
Application exceptions: Missing information does not mean that concomitant medication was absent.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N11 · Are 84 completers and allocation/measurement/analysis denominators by arm verified?

Current findings: The original evidence-table sample entry states 84 completers, and the reader answer also describes an 84-completer trial.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Total allocation, completers by arm, measurements/analyses at each assessment and ITT/PP denominators were not verified in this work.
Reason for missing information: Total allocation, completers by arm, measurements/analyses at each assessment and ITT/PP denominators were not verified in this work.
Required materials and conditions: Allocation/measurement/completion/analysis flow and denominators by arm/assessment day.
Materials to obtain first: Allocation/measurement/completion/analysis flow and denominators by arm/assessment day.
Further research: Link participant flow and denominators in each pain-result table without transferring the 84-completer count to another analysis population.
Remaining uncertainty: Total allocation, completers by arm, measurements/analyses at each assessment and ITT/PP denominators were not verified in this work.
Conditions for verification: Check the report of 84 completers against actual separate allocation, measurement and time-specific analysis denominators by arm.
Why this condition is needed: Do not automatically substitute completers for randomized participants, ITT participants or denominators by arm.
Application exceptions: Do not split 84 equally between arms or calculate 0 missing participants.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N12 · Are reasons for dropout/missingness and their handling in the pain analysis verified?

Current findings: The retained source provides only 84 completers; actual allocation/dropout/missingness flow is not provided.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Reasons for dropout/time-specific missingness and their handling in pain analysis were not acquired. Missing-participant counts and bias magnitude were not calculated.
Reason for missing information: Reasons for dropout/time-specific missingness and their handling in pain analysis were not acquired. Missing-participant counts and bias magnitude were not calculated.
Required materials and conditions: Dropout/missingness reasons, timing, handling and sensitivity analyses by arm.
Materials to obtain first: Dropout/missingness reasons, timing, handling and sensitivity analyses by arm.
Further research: Link participant flow to time-specific pain data to examine missingness-related selection and limitations in interpreting the effect of interest.
Remaining uncertainty: Reasons for dropout/time-specific missingness and their handling in pain analysis were not acquired. Missing-participant counts and bias magnitude were not calculated.
Conditions for verification: Check actual dropout, missingness by assessment day, reasons and pain-analysis/sensitivity handling by arm.
Why this condition is needed: The information that 84 completed the trial does not establish absence of losses.
Application exceptions: Do not fill missing flow information with complete follow-up or 0 dropouts.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N13 · Are between-arm/within-arm contrasts, analytical models and effects of interest at each assessment verified?

Current findings: The manuscript describes lower pain scores than vehicle, but does not provide an exact estimate combining all follow-up days or a single prespecified primary outcome.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Actual time-specific contrasts, final values/changes, analysis populations and repeated-measures/adjustment models were not verified.
Reason for missing information: Actual time-specific contrasts, final values/changes, analysis populations and repeated-measures/adjustment models were not verified.
Required materials and conditions: Contrast definitions, time-specific original results, models, ITT/PP and adjustment/repeated-measures handling.
Materials to obtain first: Contrast definitions, time-specific original results, models, ITT/PP and adjustment/repeated-measures handling.
Further research: Compare arm order, assessment time and analysis populations in pain-result tables with model descriptions to establish the actual estimated effect.
Remaining uncertainty: Actual time-specific contrasts, final values/changes, analysis populations and repeated-measures/adjustment models were not verified.
Conditions for verification: Check actual arm order, final values/changes, between-arm/within-arm contrasts, repeated-measures models and analysis populations for each pain result.
Why this condition is needed: Do not turn P values or directions from multiple assessment days into one integrated between-arm change.
Application exceptions: Do not invent ITT, change scores or time-integrated models when the original record does not identify the analysis.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N14 · Are the reported lower pain scores and actual time-specific between-group values verified?

Current findings: The original evidence result and cited result summary retain lower scores than vehicle and P<.05.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Exact pain values by arm at each assessment, differences, denominators and test definitions were not verified within this retained scope.
Reason for missing information: Exact pain values by arm at each assessment, differences, denominators and test definitions were not verified within this retained scope.
Required materials and conditions: Pain values by arm at each assessment, denominators, actual contrasts and P-test definitions.
Materials to obtain first: Pain values by arm at each assessment, denominators, actual contrasts and P-test definitions.
Further research: Attribute each result to the same assessment time, scale, comparison and denominator to compare the original favorable direction with actual magnitude.
Remaining uncertainty: Exact pain values by arm at each assessment, differences, denominators and test definitions were not verified within this retained scope.
Conditions for verification: Retain the original lower-than-vehicle/P<.05 record and check actual assessment time, arm means/changes, denominators and contrast values.
Why this condition is needed: Retain the favorable direction while preserving uncertainty about effect size.
Application exceptions: P<.05 alone does not establish a clinically large effect, cure or confirmed replication.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N15 · Are between-group pain differences, variance, denominators and 95% CI verified?

Current findings: The retained record describes an unreported/unverified exact between-group difference and 95% CI, retaining only lower pain scores and P<.05.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Only the historical bibliographic/abstract summary was read in this work; actual contrasts, variance, denominators and CI were not verified. Do not extend this limited status to nonreporting throughout the paper.
Reason for missing information: Only the historical bibliographic/abstract summary was read in this work; actual contrasts, variance, denominators and CI were not verified. Do not extend this limited status to nonreporting throughout the paper.
Required materials and conditions: Effect, variance type, denominators, 95% CI and analytical explanations for each actual contrast.
Materials to obtain first: Effect, variance type, denominators, 95% CI and analytical explanations for each actual contrast.
Further research: Link original contrasts, variance, denominators and reported intervals to establish which effect the uncertainty concerns. Do not back-calculate in this work.
Remaining uncertainty: Only the historical bibliographic/abstract summary was read in this work; actual contrasts, variance, denominators and CI were not verified. Do not extend this limited status to nonreporting throughout the paper.
Conditions for verification: Check pain differences, SD/SE, denominators and reported 95% CI for the selected actual contrast.
Why this condition is needed: Neither 84 participants nor statistical significance substitutes for a precise effect.
Application exceptions: Do not invent a fixed minimum sample size or standard duration as a precision criterion.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N16 · Are prespecified hierarchy and multiplicity handling across outcomes and assessment days verified?

Current findings: The original core description distinguishes pain, size, erythema and exudation, and the rationale states that a single prespecified primary outcome is not provided.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Multiple outcomes are known, but actual material on a single prespecified primary outcome, assessment-day hierarchy, multiplicity and reasons for changes remains unverified.
Reason for missing information: Multiple outcomes are known, but actual material on a single prespecified primary outcome, assessment-day hierarchy, multiplicity and reasons for changes remains unverified.
Required materials and conditions: Outcome/time hierarchy, multiplicity and reasons for changes in the protocol, registration and SAP.
Materials to obtain first: Outcome/time hierarchy, multiplicity and reasons for changes in the protocol, registration and SAP.
Further research: Link prespecified plans and original result tables to compare pain selection/assessment times, analytical changes and multiplicity handling.
Remaining uncertainty: Multiple outcomes are known, but actual material on a single prespecified primary outcome, assessment-day hierarchy, multiplicity and reasons for changes remains unverified.
Conditions for verification: Check the prespecified primary pain outcome, analytical hierarchy and multiplicity plans/handling among pain, size, erythema, exudation and assessment days.
Why this condition is needed: Do not confuse the page’s selected pain question with the trial’s prespecified primary outcome.
Application exceptions: Do not inherit the original false coprimary-split flag as evidence that the prespecified hierarchy of the outcomes was verified.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N17 · Are a justified important difference for aphthous pain and the actual interval verified?

Current findings: The manuscript states that the P value alone does not establish magnitude and records that exact effects and CI were not verified.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: A scale-appropriate important-difference basis and actual between-group effects/intervals for comparison remain unverified.
Reason for missing information: A scale-appropriate important-difference basis and actual between-group effects/intervals for comparison remain unverified.
Required materials and conditions: Scale-specific important-difference basis, actual contrasts/CI and patient-relevant interpretation.
Materials to obtain first: Scale-specific important-difference basis, actual contrasts/CI and patient-relevant interpretation.
Further research: Compare the important-difference basis with actual between-group estimates/intervals for the same scale, population and period to examine the interpretable scope.
Remaining uncertainty: A scale-appropriate important-difference basis and actual between-group effects/intervals for comparison remain unverified.
Conditions for verification: Check a justified important-difference criterion for this population/pain scale against actual between-group estimates and intervals.
Why this condition is needed: Do not automatically equate statistical significance with a magnitude experienced by patients.
Application exceptions: Do not adopt arbitrary VAS points, fulfilment proportions or trial-count criteria.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N18 · Are the actual identity and specifications of trial registration, protocol and SAP verified?

Current findings: The original registration field states that it could not be verified, and the reader answer also states that registration was not verified.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Actual registration/protocol/SAP identity and specifications were not acquired in the retained input. This does not establish that the trial was unregistered.
Reason for missing information: Actual registration/protocol/SAP identity and specifications were not acquired in the retained input. This does not establish that the trial was unregistered.
Required materials and conditions: Registration number, original registration/protocol/SAP, registration date and change history.
Materials to obtain first: Registration number, original registration/protocol/SAP, registration date and change history.
Further research: Once identity is acquired, compare original outcomes/results/times with prespecified specifications and changes. Do not equate currently unverified registration with nonregistration.
Remaining uncertainty: Actual registration/protocol/SAP identity and specifications were not acquired in the retained input. This does not establish that the trial was unregistered.
Conditions for verification: Separately from the unverified registration record, check actual registration/protocol/SAP identity, dates and outcome/analysis specifications.
Why this condition is needed: Unverified registration number does not establish lack of a prespecified plan or confirmed selective reporting.
Application exceptions: No new search or external registration access is performed in this work.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N19 · Are the family link for this report and other direct independent replication materials verified?

Current findings: 1 evidence entry and 1 citation link Jiang 2013, PMID 23246229 and DOI 10.1016/j.oooo.2012.09.009; the original manuscript describes one trial and unverified independent replication.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Retained report identity is verified, but comparison of unique families through registration/recruitment cohorts and actual material on other direct independent replications remains unverified.
Reason for missing information: Retained report identity is verified, but comparison of unique families through registration/recruitment cohorts and actual material on other direct independent replications remains unverified.
Required materials and conditions: Report/trial-family map, registration links and identity of replication material for the same question.
Materials to obtain first: Report/trial-family map, registration links and identity of replication material for the same question.
Further research: Compare the relationships among PMID/DOI/registration, recruitment cohorts and assessment times to distinguish repeat citations from independent replication. Do not conduct a new exhaustive search or sum participants.
Remaining uncertainty: Retained report identity is verified, but comparison of unique families through registration/recruitment cohorts and actual material on other direct independent replications remains unverified.
Conditions for verification: Check the linked Jiang report/PMID/DOI and identity/independence of other comparisons with the same formulation, population and pain outcome.
Why this condition is needed: Do not count a paper and its PubMed entry point as separate independent evidence.
Application exceptions: Do not turn absence of a search in this work or unverified replication in the original into 0 worldwide trials or an exact replication count.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N20 · Are all assessment times and null or unfavorable results for the same pain question verified?

Current findings: The retained summary describes lower pain scores/P<.05 and a consistent direction, but does not provide all time-specific values.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The summary read in this work does not verify all null/unfavorable pain results or the scope of selective reporting.
Reason for missing information: The summary read in this work does not verify all null/unfavorable pain results or the scope of selective reporting.
Required materials and conditions: Complete pain-result tables, assessment times/denominators, supplementary material and selection criteria.
Materials to obtain first: Complete pain-result tables, assessment times/denominators, supplementary material and selection criteria.
Further research: Compare all pain results by assessment time, scale and contrast to examine favorable-result selection without treating different outcomes as conflicts.
Remaining uncertainty: The summary read in this work does not verify all null/unfavorable pain results or the scope of selective reporting.
Conditions for verification: Check actual time-specific favorable, null and unfavorable pain results, contrasts, denominators and reporting scope.
Why this condition is needed: A favorable P-value summary does not establish the same direction for every result or absence of contrary results.
Application exceptions: Do not automatically classify numerical differences in other ulcer outcomes as conflicting pain data.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N21 · Are government support, product provision, author employment and full COI material verified?

Current findings: The original funding record describes Chinese non-US government research support and unverified product/COI details.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Actual funding details, product provision, author-specific employment/COI and design/analysis control remain unverified.
Reason for missing information: Actual funding details, product provision, author-specific employment/COI and design/analysis control remain unverified.
Required materials and conditions: Funding details, product provision, author employment/disclosures and design/analysis roles.
Materials to obtain first: Funding details, product provision, author employment/disclosures and design/analysis roles.
Further research: Link funding, product and author documents to design/analysis roles to examine actual disclosure levels and remaining uncertainty.
Remaining uncertainty: Actual funding details, product provision, author-specific employment/COI and design/analysis control remain unverified.
Conditions for verification: Check the Chinese non-US government-support record against actual product provision, author employment, roles and full COI disclosures.
Why this condition is needed: Government-support wording does not establish absence of product/COI issues or proven independence.
Application exceptions: Do not infer absence of bias from the original I1 label or funding name alone.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N22 · Are the short-term report on 84 people, actual safety denominators, event definitions and collection verified?

Current findings: The original safety explanation states that no obvious adverse effects occurred in a short trial involving 84 people.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Actual exposure/safety denominators, event counts by arm, diagnosis/collection and detailed dropout/discontinuation information remain unverified. Do not convert this to 0 total events in 84 people.
Reason for missing information: Actual exposure/safety denominators, event counts by arm, diagnosis/collection and detailed dropout/discontinuation information remain unverified. Do not convert this to 0 total events in 84 people.
Required materials and conditions: All exposed/safety denominators, event/person counts by arm, collection methods and discontinuation reasons.
Materials to obtain first: All exposed/safety denominators, event/person counts by arm, collection methods and discontinuation reasons.
Further research: Link exposure by arm with safety tables/collection procedures to compare the scope of the completer-sample description with all actually exposed participants.
Remaining uncertainty: Actual exposure/safety denominators, event counts by arm, diagnosis/collection and detailed dropout/discontinuation information remain unverified. Do not convert this to 0 total events in 84 people.
Conditions for verification: Check the short-term description of no obvious adverse effects against actual separate exposed/safety denominators, event definitions, collection and discontinuation reasons by arm.
Why this condition is needed: Do not extend an absence description from short-term completers to 0 events overall or to proven safety.
Application exceptions: Do not delete the retained pain observation because harm material is unverified or calculate a new incidence.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N23 · Are actual irritation, allergy and swallowed-exposure events, timing and alternative explanations verified?

Current findings: The original safety statement records that safety concerning local irritation, allergy and swallowed exposure is not established.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: This input lacks actual person/event counts, exposure/timing, discontinuation/recovery and baseline/co-intervention material for those events; risk magnitude and causality were not verified.
Reason for missing information: This input lacks actual person/event counts, exposure/timing, discontinuation/recovery and baseline/co-intervention material for those events; risk magnitude and causality were not verified.
Required materials and conditions: Irritation/allergy/swallowing events, exposure amount/timing, baseline/co-interventions and discontinuation/recovery.
Materials to obtain first: Irritation/allergy/swallowing events, exposure amount/timing, baseline/co-interventions and discontinuation/recovery.
Further research: Link event records to actual local/swallowed exposure, timing and alternative explanations/comparators to examine the scope of what can be said.
Remaining uncertainty: This input lacks actual person/event counts, exposure/timing, discontinuation/recovery and baseline/co-intervention material for those events; risk magnitude and causality were not verified.
Conditions for verification: Check event definitions, exposure/onset, discontinuation/recovery, concurrent exposure and comparisons, distinguishing signal, frequency and causality.
Why this condition is needed: Do not turn unverified safety issues into observed events or confirmed causality.
Application exceptions: Missing event material does not establish that irritation or allergy did not occur.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N24 · Are pregnancy/lactation and safety/interaction materials beyond short follow-up verified?

Current findings: The original safety explanation specifies that pregnancy/lactation safety is not established; the trial is short term at 5 days.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Direct material on these vulnerable populations, long-term/repeated exposure and interactions was not checked in this work. No new personal-use instructions are created.
Reason for missing information: Direct material on these vulnerable populations, long-term/repeated exposure and interactions was not checked in this work. No new personal-use instructions are created.
Required materials and conditions: Direct exposure, events, duration and concomitant-use/interaction material by population.
Materials to obtain first: Direct exposure, events, duration and concomitant-use/interaction material by population.
Further research: Compare vulnerable-population/repeated-exposure material by formulation, route, population and follow-up, separating it from short-term general-adult material.
Remaining uncertainty: Direct material on these vulnerable populations, long-term/repeated exposure and interactions was not checked in this work. No new personal-use instructions are created.
Conditions for verification: Check direct exposure/event/comparison material on pregnancy, lactation, long-term/repeated application and concomitant medication.
Why this condition is needed: Do not extend 5-day general-adult material to pregnancy/lactation or overall long-term safety.
Application exceptions: Do not require every rare-harm study as a mandatory effect criterion for the original pain question.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N25 · Were the pain effect and safety limitations retained as separate records?

Current findings: Lower pain scores than vehicle/P<.05 are retained separately from the original Caution label and unverified local irritation, allergy, swallowing, pregnancy and lactation.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Met status is limited to separating attribution of efficacy and safety records. Actual harm-material criteria remain unverified/partly verified.
Reason for missing information: Met status is limited to separating attribution of efficacy and safety records. Actual harm-material criteria remain unverified/partly verified.
Required materials and conditions: Links among pain observations, original safety text, denominators/duration and interpretation boundaries.
Materials to obtain first: Links among pain observations, original safety text, denominators/duration and interpretation boundaries.
Further research: When subsequent efficacy/safety material arrives, compare outcome, denominator, period and actual reading scope separately and update the relevant links.
Remaining uncertainty: Met status is limited to separating attribution of efficacy and safety records. Actual harm-material criteria remain unverified/partly verified.
Conditions for verification: Link the original pain observation/P value and Caution/safety gaps separately; do not inherit efficacy reporting as safety verification.
Why this condition is needed: A favorable efficacy direction must not erase safety gaps.
Application exceptions: Meeting this record-separation criterion does not establish safety concerning irritation/allergy or pregnancy/lactation.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N26 · Does this checklist additionally require verification of optimal dosing or long-term persistence?

Current findings: The original scope is pain with topical 5 mg/g gelatin applied 4 times daily for 5 days. Optimal concentration/frequency and long-term persistence were not selected claims.
Verification status: Not applicable
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Do not add optimal dosing or long-term persistence as mandatory extensions to the original claim. This does not establish lack of such effects or complete absence of material.
Reason for missing information: Do not add optimal dosing or long-term persistence as mandatory extensions to the original claim. This does not establish lack of such effects or complete absence of material.
Required materials and conditions: For an extension claim: direct concentration/dose comparisons and long-term/withdrawal material.
Materials to obtain first: For an extension claim: direct concentration/dose comparisons and long-term/withdrawal material.
Further research: If that extension is separately requested, examine designs comparing concentration/frequency and withdrawal/long-term results using the same pain definition.
Remaining uncertainty: Do not add optimal dosing or long-term persistence as mandatory extensions to the original claim. This does not establish lack of such effects or complete absence of material.
Conditions for verification: Do not add optimal concentration/frequency, long-term persistence or withdrawal effects as mandatory confirmation beyond the selected 5 mg/g, 4-times-daily, 5-day scope.
Why this condition is needed: Do not combine the narrow pain question with every dose-finding or persistence study.
Application exceptions: Actual nominal/application amount is covered in a separate row; unverified optimal amounts do not establish safe amounts.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N27 · Does the same effect question include size, erythema, exudation, healing, recurrence or infection treatment?

Current findings: The original core description distinguishes four outcomes, and the advertising-limit text restricts extensions to cure, recurrence prevention, infection treatment and oral-systemic effects.
Verification status: Not applicable
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: These are not direct outcomes of the selected pain question. Nonapplicability does not establish an effect of 0 on other outcomes or worldwide absence of healing/recurrence material.
Reason for missing information: These are not direct outcomes of the selected pain question. Nonapplicability does not establish an effect of 0 on other outcomes or worldwide absence of healing/recurrence material.
Required materials and conditions: For an extension: direct outcome definitions, comparisons, denominators, periods and results.
Materials to obtain first: For an extension: direct outcome definitions, comparisons, denominators, periods and results.
Further research: When separately examining an extension, design analyses separating its prespecified definition, direct results, denominators and period from pain.
Remaining uncertainty: These are not direct outcomes of the selected pain question. Nonapplicability does not establish an effect of 0 on other outcomes or worldwide absence of healing/recurrence material.
Conditions for verification: Separate the selected pain outcome from size/erythema/exudation, healing duration, recurrence and infection treatment; do not add those extensions as mandatory outcomes here.
Why this condition is needed: Do not extend a significant symptom score to cure or preventive effects.
Application exceptions: Retain other outcome observations, but do not invent values/effects absent from the retained source.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N28 · Were the local summary, historical bibliography/abstract checks and currently unread external material distinguished?

Current findings: The entire retained summary was actually read in this work. The manuscript records checking the PMID 23246229 bibliography/abstract, but has no individual access-date/level/location records.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Verification concerns material-specific actions and historical boundaries. Full paper, registration/protocol and external bibliography/abstract access were not attempted; they remain unread in this work.
Reason for missing information: Verification concerns material-specific actions and historical boundaries. Full paper, registration/protocol and external bibliography/abstract access were not attempted; they remain unread in this work.
Required materials and conditions: Material identity, links/original locations, actual reading scope, dates and original-document SHA.
Materials to obtain first: Material identity, links/original locations, actual reading scope, dates and original-document SHA.
Further research: Link actual access/reading events, locations, dates and SHA for subsequent material, keeping them separate from historical access.
Remaining uncertainty: Verification concerns material-specific actions and historical boundaries. Full paper, registration/protocol and external bibliography/abstract access were not attempted; they remain unread in this work.
Conditions for verification: Distinguish actual reading of the retained summary, the historical bibliography/abstract-check narrative, absent individual access records and external access not attempted/unread in this work.
Why this condition is needed: A PubMed link or an original bibliography/abstract-check statement does not establish full-text reading in this work.
Application exceptions: Do not assign inaccessible status to external material when access was not attempted.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N29 · Were the original types and records for C46, axes/flags and corrections retained?

Current findings: Original C46, B/P/R1/I1/EX/B2/CX, false flags, empty subclaim lists/text fields and the 2026-09-14 English-placeholder correction are preserved in the retained original.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: This verifies types/original-text preservation, not current revalidation of C46 or calculation of an efficacy score or fulfilment proportion.
Reason for missing information: This verifies types/original-text preservation, not current revalidation of C46 or calculation of an efficacy score or fulfilment proportion.
Required materials and conditions: Original verdict, score/axes, flags, original decisions/corrections and whole-input SHA.
Materials to obtain first: Original verdict, score/axes, flags, original decisions/corrections and whole-input SHA.
Further research: If changes are requested, preserve the full previous text and case/version records to compare actual differences. This work does not reassess the verdict.
Remaining uncertainty: This verifies types/original-text preservation, not current revalidation of C46 or calculation of an efficacy score or fulfilment proportion.
Conditions for verification: Link grade C, score 46, original axes/false flags, empty strings/arrays, grade decisions and corrections/dates to the exact input; do not inherit them as new condition scores.
Why this condition is needed: Do not confuse the earlier clinical verdict with preparation of the current evidence checklist.
Application exceptions: Do not fill absent grade-revalidation, evidence-status or access fields with false values or new verification claims.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N30 · Were the original evidence date, current review date and scope of searches/checks distinguished?

Current findings: The original review date is 2026-09-08, the correction date is 2026-09-14 and the review date for the case record is 2026-10-05. No new search, full-text access, clinical calculation or reassessment is performed in this work.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Met status is limited to recording dates and authorized scope. It does not verify completeness of all current literature.
Reason for missing information: Met status is limited to recording dates and authorized scope. It does not verify completeness of all current literature.
Required materials and conditions: Original review date, case-review date, inputs used and actual search/calculation/access events.
Materials to obtain first: Original review date, case-review date, inputs used and actual search/calculation/access events.
Further research: When additional events occur, distinguish their performed scope/dates from historical records and link them to the relevant rows.
Remaining uncertainty: Met status is limited to recording dates and authorized scope. It does not verify completeness of all current literature.
Conditions for verification: Link the original review date with the case-review date, inputs used and the record of 0 new searches, calculations or external accesses in this work.
Why this condition is needed: Do not turn the original evidence date into a date claiming completion of a current exhaustive literature search.
Application exceptions: Do not invent an original evidence-cutoff field or claim that it was the same field as the recorded review date.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N31 · Were original search strategies, dates, screening/exclusions and unpublished/correction-check logs acquired?

Current findings: The research-review text describes checking a PMID record/abstract and excluding oral berberine, ulcer size and healing duration.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: That scope is described, but actual search strategies/dates, screening results/exclusion lists and unpublished/correction logs are not verified in this retained source.
Reason for missing information: That scope is described, but actual search strategies/dates, screening results/exclusion lists and unpublished/correction logs are not verified in this retained source.
Required materials and conditions: Historical search strategies/dates, search results, screening/exclusions and registration/unpublished/correction-check logs.
Materials to obtain first: Historical search strategies/dates, search results, screening/exclusions and registration/unpublished/correction-check logs.
Further research: If historical logs are acquired, compare formulation/route/population/pain eligibility with search, screening and exclusion reasons. Do not conduct a new search in this work.
Remaining uncertainty: That scope is described, but actual search strategies/dates, screening results/exclusion lists and unpublished/correction logs are not verified in this retained source.
Conditions for verification: Beyond the bibliography/abstract checks and oral/other-outcome exclusions, check actual search strategies/dates, results/screening and unpublished/registration/correction logs.
Why this condition is needed: Reading a retained abstract does not establish verification of all clinical literature.
Application exceptions: Unverified logs do not establish 0 human studies, 0 effect or 0 retractions.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N32 · Were update criteria distinguishing new material from condition-version changes recorded?

Current findings: The checklist provides update rules distinguishing evidence additions from condition revisions and requiring actual material locations, reading, dates and SHA.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: This is a record rule for this checklist. It does not establish completion of new clinical material, full-text reading, searches or condition updates.
Reason for missing information: This is a record rule for this checklist. It does not establish completion of new clinical material, full-text reading, searches or condition updates.
Required materials and conditions: Actual subsequent originals, reading/dates, locations/values/SHA, full previous versions and condition versions/reasons for changes.
Materials to obtain first: Actual subsequent originals, reading/dates, locations/values/SHA, full previous versions and condition versions/reasons for changes.
Further research: Compare actual subsequent material with question eligibility, outcome/time, denominators and comparator, then review the relevant rows. Freeze a separate version before applying condition revisions.
Remaining uncertainty: This is a record rule for this checklist. It does not establish completion of new clinical material, full-text reading, searches or condition updates.
Conditions for verification: Provide rules recording evidence additions with actual identity/reading/locations/values/SHA separately from revisions of the question or criteria.
Why this condition is needed: Material additions or display changes must not automatically become clinical confirmation.
Application exceptions: Recording this update rule does not perform subsequent checks, reassessment or deployment.
Referenced methods: Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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