Investigating the clinical effect of nanofibers containing colchicine as an anti-aphthous drug
Design
A controlled, parallel-group, open-label, randomized, phase 2 clinical trial on 20 patients. Random allocation software will be used for randomization.
Settings and conduct
This clinical trial study will be conducted in order to evaluate the effect of polymeric nanofibers carrying colchicine in the treatment of oral thrush, on 20 patients hospitalized in Zaytoun Medical Complex in 1401-1402.
The size of the lesion will be determined based on the maximum diameter of the wound by placing one-millimeter grid paper (transparent paper rulers that are marked as 1 mm units and are disposable). The patient's pain and burning sensation will be evaluated according to VAS, which is a line of 100 mm. Zero means no pain and 100 indicates the most pain the patient has experienced in his lifetime.
Participants/Inclusion and exclusion criteria
Inclusion Criteria :
Age range between 20 and 40 years
No more than a day has passed since the beginning of aphthous ulcers
Not using another treatment method for your aphthous lesions before visiting
No history of known systemic disease associated with aphthous ulcers
Not having suspicious symptoms of systemic diseases related to aphthous ulcers
Exclusion Criteria :
Recent use of colchicine
Using another drug simultaneously with the drugs prescribed to treat the pest
Not to use the medicine as recommended according to the patient's own statements
Failure to return the patient for re-examination
The presence of lesions in the area of the tonsils and the posterior 1/3 of the mouth
Concomitant use of immunosuppressive drugs
Lactating and pregnant women
Intervention groups
The intervention group includes group A (triamcinolone oral gel) or group B (nanofibers carrying the drug colchicine).
Main outcome variables
Size of the lesion; pain and burning
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160920029889N4
Registration date:2023-01-07, 1401/10/17
Registration timing:prospective
Last update:2023-01-07, 1401/10/17
Update count:0
Registration date
2023-01-07, 1401/10/17
Registrant information
Name
Afshin Shiva
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4991
Email address
shiva@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-14, 1401/10/24
Expected recruitment end date
2023-06-14, 1402/03/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the clinical efficacy of Colchicine-loaded polymeric nanofibers on aphthous ulceration, A Pilot Study
Public title
Effect of Colchicine on aphthous ulceration.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 20 and 40 years
No more than a day has passed since the beginning of aphthous ulcers
Not using another treatment method for your aphthous lesions before visiting
No history of known systemic disease associated with aphthous ulcers
Not having suspicious symptoms of systemic diseases related to aphthous ulcers
Exclusion criteria:
Recent use of colchicine
Using another drug simultaneously with the drugs prescribed to treat the pest
Not to use the medicine as recommended according to the patient's own statements
Failure to return the patient for re-examination
The presence of lesions in the area of the tonsils and the posterior 1/3 of the mouth
Concomitant use of immunosuppressive drugs
Lactating and pregnant women
Age
From 20 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
First, eligible patients will be selected non-randomized, sequential. Then these patients are coded using computer random allocation software, and then the codes are divided into two parts, and each part of the codes will be assigned to a group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Valie-Asr Boulevard
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2022-10-18, 1401/07/26
Ethics committee reference number
IR.MAZUMS.RIB.REC.1401.039
Health conditions studied
1
Description of health condition studied
Aphthous
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Pain score
Timepoint
Before and 7 days after the start of treatment
Method of measurement
Visual Analogue Scale
2
Description
Size of the lesion
Timepoint
Before and 7 days after the start of treatment
Method of measurement
Graph paper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A circular piece of polymer nanofibers with a diameter of 1.2 cm containing 1 mg of colchicine is prescribed to each patient and he will be taught to place the piece directly on the aphthous lesion without drying the mucous membrane of the wound. then it will be emphasized that the mouth should be open for two minutes and after connecting the nanofiber mat to the relevant surface, refrain from moving it with the help of the tongue so that the medicine is released slowly. This procedure is performed 3 times a day. The patient will be taught that if the mucous surface is dry before using the medicine, after placing the mat on the lesion, ensure that the mat is moistened. In addition, the medicine should be used after eating and avoid eating and drinking for an hour after that.
Category
Treatment - Drugs
2
Description
Control group: each patient will be given a package and will be taught to first dry the mucous surface of the wound slowly and then soak a small piece of sanitary cotton measuring about 3 x 3 centimeters with medicine and place it on the infected lesion. Then it will be emphasized that the mouth should be open for two minutes and perform this action 3 times a day. The patient will be taught to use the medicine after eating and to avoid eating and drinking for an hour after.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zeytoun Medical Center
Full name of responsible person
Mohammad bagher Maher
Street address
No 5, Zeytoun Center, Hassani Ave.
City
Urmia
Province
West Azarbaijan
Postal code
7494158557
Phone
+98 44 3347 3341
Email
nasim.maher95@gmial.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnezhad
Street address
Mazandaran university of medical sciences, Moallem square
City
Sari
Province
Mazandaran
Postal code
48175-866
Phone
+98 911 115 2323
Email
research@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?