# Topical berberine gelatin 5 mg/g × Reduction of pain from minor recurrent aphthous ulcers Verdict 3076 · Evidence Check Stored-material review date: 2026-10-05 Original evidence review date: 2026-09-08 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-27 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: 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. ## Checklist items ### N01 · Which topical formulation, population and pain comparison does this checklist address? Verification status: Met Reading scope: 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. - 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. - 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. - 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. - Remaining uncertainty: Verification concerns the original claim identity and exclusion boundaries. It does not establish precise estimation of the pain effect or 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. - Related sources: S01 ### N02 · Are diagnosis, eligibility and baseline characteristics of minor recurrent aphthous stomatitis verified? Verification status: Partly verified Reading scope: 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. - Current findings: The original claim conditions specify adults with minor recurrent aphthous stomatitis, and the evidence table names a trial in a Chinese cohort. - 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. - 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. - Remaining uncertainty: Actual diagnostic methods, age range, baseline ulcers/pain by arm and full eligibility criteria were not verified within the retained material. - 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? Verification status: Partly verified Reading scope: 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. - 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. - 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. - 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. - Remaining uncertainty: Original material on the actual batch, full composition/vehicle, salt form and manufacturing assays was not verified within the retained scope. - 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? Verification status: Partly verified Reading scope: 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. - Current findings: The original nominal frequency is 4 times daily, and the formulation concentration is 5 mg/g. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: 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. - Current findings: The comparator is vehicle gelatin without berberine, and the original design is recorded as vehicle-placebo controlled. - 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. - 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. - Remaining uncertainty: Actual material on detailed vehicle composition/appearance, oral care, rescue treatment and handling of changes by arm remains 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 ### N06 · Were the original treatment and assessment time boundaries distinguished? Verification status: Met Reading scope: 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. - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: 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. - Current findings: The original evidence records a randomized double-blind vehicle-placebo trial. - 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. - 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. - Remaining uncertainty: Actual sequence generation, allocation concealment and baseline balance by arm are not verified from the retained material 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. - Related sources: S01 ### N08 · Whose masking and its actual maintenance are verified? Verification status: Partly verified Reading scope: 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. - Current findings: The trial is described as a double-blind vehicle-placebo trial. - 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. - 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. - Remaining uncertainty: The actual masking targets, methods, maintenance/testing and assessor/analyst status are not specified in 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. - Related sources: S01 ### N09 · Are the pain scale, range, direction and collection method verified? Verification status: Partly verified Reading scope: 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. - Current findings: The original measured outcome is pain VAS/score across assessment days, and the manuscript describes lower pain scores than vehicle. - 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. - 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. - Remaining uncertainty: The exact scale range, units, direction definition, assessors, collection procedures and time-specific between-group results 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 ### N10 · Are analgesics, oral treatment and handling of adherence/rescue treatment by arm verified? Verification status: Unverified Reading scope: 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. - Current findings: The retained source describes topical gelatin versus vehicle, but does not separately provide analgesics, oral treatment or rescue-treatment handling by arm. - 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. - 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. - 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. - 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 ### N11 · Are 84 completers and allocation/measurement/analysis denominators by arm verified? Verification status: Partly verified Reading scope: 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. - Current findings: The original evidence-table sample entry states 84 completers, and the reader answer also describes an 84-completer trial. - 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. - 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. - Remaining uncertainty: Total allocation, completers by arm, measurements/analyses at each assessment and ITT/PP denominators were not verified 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. - Related sources: S01 ### N12 · Are reasons for dropout/missingness and their handling in the pain analysis verified? Verification status: Unverified Reading scope: 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. - Current findings: The retained source provides only 84 completers; actual allocation/dropout/missingness flow is not provided. - 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. - 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. - 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. - 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 ### N13 · Are between-arm/within-arm contrasts, analytical models and effects of interest at each assessment verified? Verification status: Unverified Reading scope: 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. - 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. - 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. - 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. - Remaining uncertainty: Actual time-specific contrasts, final values/changes, analysis populations and repeated-measures/adjustment models were not 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. - Related sources: S01 ### N14 · Are the reported lower pain scores and actual time-specific between-group values verified? Verification status: Partly verified Reading scope: 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. - Current findings: The original evidence result and cited result summary retain lower scores than vehicle and P<.05. - 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. - 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. - Remaining uncertainty: Exact pain values by arm at each assessment, differences, denominators and test definitions were not verified within this retained scope. - 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 ### N15 · Are between-group pain differences, variance, denominators and 95% CI verified? Verification status: Unverified Reading scope: 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. - Current findings: The retained record describes an unreported/unverified exact between-group difference and 95% CI, retaining only lower pain scores and P<.05. - 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. - 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. - 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. - 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 ### N16 · Are prespecified hierarchy and multiplicity handling across outcomes and assessment days verified? Verification status: Partly verified Reading scope: 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. - 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. - 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. - 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. - 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. - 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 ### N17 · Are a justified important difference for aphthous pain and the actual interval verified? Verification status: Unverified Reading scope: 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. - Current findings: The manuscript states that the P value alone does not establish magnitude and records that exact effects and CI were not verified. - 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. - 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. - Remaining uncertainty: A scale-appropriate important-difference basis and actual between-group effects/intervals for comparison 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 ### N18 · Are the actual identity and specifications of trial registration, protocol and SAP verified? Verification status: Unverified Reading scope: 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. - Current findings: The original registration field states that it could not be verified, and the reader answer also states that registration was not verified. - 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. - 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. - 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. - 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 ### N19 · Are the family link for this report and other direct independent replication materials verified? Verification status: Partly verified Reading scope: 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. - 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. - 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. - 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. - 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. - 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 ### N20 · Are all assessment times and null or unfavorable results for the same pain question verified? Verification status: Partly verified Reading scope: 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. - Current findings: The retained summary describes lower pain scores/P<.05 and a consistent direction, but does not provide all time-specific values. - 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. - 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. - Remaining uncertainty: The summary read in this work does not verify all null/unfavorable pain results or the scope of 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. - Related sources: S01 ### N21 · Are government support, product provision, author employment and full COI material verified? Verification status: Partly verified Reading scope: 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. - Current findings: The original funding record describes Chinese non-US government research support and unverified product/COI details. - 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. - 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. - Remaining uncertainty: Actual funding details, product provision, author-specific employment/COI and design/analysis control 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 ### N22 · Are the short-term report on 84 people, actual safety denominators, event definitions and collection verified? Verification status: Partly verified Reading scope: 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. - Current findings: The original safety explanation states that no obvious adverse effects occurred in a short trial involving 84 people. - 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. - 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. - 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. - 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 ### N23 · Are actual irritation, allergy and swallowed-exposure events, timing and alternative explanations verified? Verification status: Unverified Reading scope: 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. - Current findings: The original safety statement records that safety concerning local irritation, allergy and swallowed exposure is not established. - 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. - 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. - 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. - 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 ### N24 · Are pregnancy/lactation and safety/interaction materials beyond short follow-up verified? Verification status: Unverified Reading scope: 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. - Current findings: The original safety explanation specifies that pregnancy/lactation safety is not established; the trial is short term at 5 days. - 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. - 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. - 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. - 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 ### N25 · Were the pain effect and safety limitations retained as separate records? Verification status: Met Reading scope: 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. - 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. - 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. - 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. - Remaining uncertainty: Met status is limited to separating attribution of efficacy and safety records. Actual harm-material criteria remain unverified/partly 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. - Related sources: S01 ### N26 · Does this checklist additionally require verification of optimal dosing or long-term persistence? Verification status: Not applicable Reading scope: 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. - 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. - 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. - 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. - 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. - 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 ### N27 · Does the same effect question include size, erythema, exudation, healing, recurrence or infection treatment? Verification status: Not applicable Reading scope: 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. - 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. - 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. - 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. - 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. - 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 ### N28 · Were the local summary, historical bibliography/abstract checks and currently unread external material distinguished? Verification status: Met Reading scope: 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. - 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. - 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. - 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. - 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. - 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 ### N29 · Were the original types and records for C46, axes/flags and corrections retained? Verification status: Met Reading scope: 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. - 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. - 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. - 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. - Remaining uncertainty: This verifies types/original-text preservation, not current revalidation of C46 or calculation of an efficacy score or fulfilment proportion. - 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 ### N30 · Were the original evidence date, current review date and scope of searches/checks distinguished? Verification status: Met Reading scope: 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. - 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. - 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. - 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. - Remaining uncertainty: Met status is limited to recording dates and authorized scope. It does not verify completeness of all current 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. - Related sources: S01 ### N31 · Were original search strategies, dates, screening/exclusions and unpublished/correction-check logs acquired? Verification status: Partly verified Reading scope: 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. - Current findings: The research-review text describes checking a PMID record/abstract and excluding oral berberine, ulcer size and healing duration. - 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. - 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. - 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. - 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 ### N32 · Were update criteria distinguishing new material from condition-version changes recorded? Verification status: Met Reading scope: 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. - Current findings: The checklist provides update rules distinguishing evidence additions from condition revisions and requiring actual material locations, reading, dates and SHA. - 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. - 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. - 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. - 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 ## Evidence and sources ### S01 Jiang 2013 report of topical berberine gelatin and aphthous-ulcer pain [PubMed](https://pubmed.ncbi.nlm.nih.gov/23246229/) 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 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. 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. | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Link studies and reports separately; do not omit studies solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence. · 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/materials 1.0. The public view and materials were prepared from the existing 32 items. No new clinical search, verification-state change or scoring was performed.