Preparation and clinical evaluation of a novel colchicine mucoadhesive gel for the treatment of aphthous stomatitis

Preparation and clinical evaluation of a novel colchicine mucoadhesive gel for the treatment of aphthous stomatitis: An experimental study and a double blinded randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191106045356N8

Enrollment

Registered

2021-08-06

Start date

2021-08-21

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphthous stomatitis.

Interventions

Intervention 1: Intervention group: Includes 25 patients selected from the city's pharmacies and randomly selected based on the RND function of Excel software. Patients will use the prepared drug twic

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with aphthous stomatitis starting up to two days Patient between 18-65 years old No pregnancy and lactation No history of allergies to colchicine

Exclusion criteria

Exclusion criteria: Patients with skin diseases Sensitivity to colchicine or any of the components of the product Do not use the drug for two consecutive days Exacerbation of the aphthous stomatitis

Design outcomes

Primary

Measure	Time frame
Severity of pain. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of aphthous lesions is evaluated for pain intensity (score 0 to 4). Method of measurement: Scoring pain using a questionnaire.;Redness and inflammation. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of aphthous lesions is evaluated for the severity of redness and inflammation (score 0 to 4). Method of measurement: Scoring severe redness and inflammation using a questionnaire.;Total area of ??aphthous lesions. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of the aphthous lesions is evaluated in terms of the total area of ??the aphthous lesions. Method of measurement: Determining the total area of ??aphthous lesions through Fiji software.	—

Measure

Time frame

Severity of pain. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of aphthous lesions is evaluated for pain intensity (score 0 to 4). Method of measurement: Scoring pain using a questionnaire.;Redness and inflammation. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of aphthous lesions is evaluated for the severity of redness and inflammation (score 0 to 4). Method of measurement: Scoring severe redness and inflammation using a questionnaire.;Total area of ??aphthous lesions. Timepoint: At the beginning of treatment and after every 2 to 10 days, the condition of the aphthous lesions is evaluated in terms of the total area of ??the aphthous lesions. Method of measurement: Determining the total area of ??aphthous lesions through Fiji software.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohsen Zabihi

Yazd University of Medical Sciences

mzabihi100@gmail.com+98 35 3820 3865

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026