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
Preparation and clinical evaluation of a novel colchicine mucoadhesive gel for the treatment of aphthous stomatitis
Design
In this study, patients with aphthous stomatitis are selected through recall in pharmacies, physicians' offices and social networks according to the inclusion criteria and will enter the study after obtaining written consent. Patients' information including age, sex, weight, underlying diseases, and medications will be recorded. Patients using the RAND function of Excel software are randomly divided into two groups, including the colchicine group and the placebo group (basal posterior mucosa gel without colchicine) in each group of 25 people. Patients will use the drug twice a day at the rate of one drop per pest. At the beginning of treatment and after every 2 days for 10 days, the condition of aphthous lesions will be checked
Settings and conduct
A double-blind randomized controlled clinical trial in Yazd province on 50 patients in the control and intervention groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with aphthous stomatitis starting up to two days, No pregnancy and lactation, patients between 18_65 years old, No history of allergies to colchicine
Exclusion criteria: Patients with skin diseases, Sensitivity to colchicine or any of components of the product, Do not use the drug for two consecutive days, Exacerbation of the aphthous stomatitis
Intervention groups
In the present study, patients will be divided into two groups: colchicine mucoadhesive gel receiving group، Base mucoadhesive gel receiving group.
Main outcome variables
Pain، inflammation، aphthous lesions size، number of aphthous lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045356N8
Registration date:2021-08-06, 1400/05/15
Registration timing:prospective
Last update:2021-08-06, 1400/05/15
Update count:0
Registration date
2021-08-06, 1400/05/15
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-21, 1400/05/30
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Preparation and clinical evaluation of a novel colchicine mucoadhesive gel for the treatment of aphthous stomatitis
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed based on the RND function of Excel software and patients are divided into two groups A and B. The drug and placebo are uniform and coded in terms of the shape of the drug and the drug container, and the patient and the physician prescribing the drug and the evaluator do not know the composition and content of each drug container.
Blinding (investigator's opinion)
Double blinded
Blinding description
Different groups of drugs are placed in uniform and coded containers, and the prescribing physician and the evaluator do not know the composition and content of each drug container.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2021-08-21, 1400/05/30
Ethics committee reference number
.در حال دریافت کد اخلاق هستیم. لطفا دیگر ایتم ها را بررسی فرمایید تا کد اخلاق صادر شودEthics committee of Shahid Sadoughi University of Medical Sciences
Health conditions studied
1
Description of health condition studied
Aphthous stomatitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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 twice a day (0.05% colchicine adhesive mucus gel) at the rate of one drop for each aphthous. At the beginning of treatment and after every 2 to 10 days, the condition of the aphthous lesions is evaluated in terms of pain intensity (score 0 to 4), total lesion area and intensity of redness and inflammation (score 0 to 4) and number of lesions.
Category
Treatment - Drugs
2
Description
Control group: Includes 25 patients selected from the city's pharmacies and randomly selected based on the RND function of Excel software. Patients will use one placebo twice a day (base glue-free mucosal gel without colchicine) at the rate of one drop per aphthous. At the beginning of treatment and after every 2 to 10 days, the condition of the aphthous lesions is evaluated in terms of pain intensity (score 0 to 4), total lesion area and intensity of redness and inflammation (score 0 to 4) and number of lesions.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Drug stores
Full name of responsible person
Dr. Mohsen Zabihi
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masood Mirzaei
Street address
Bahonar sq.
City
Yazd
Province
Yazd
Postal code
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Email
mzabihi100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Email
mzabihi100@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Email
mzabihi100@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available