This is a triple-blind clinical trial to compare the efficacy of the drug with placebo. Patients with recurrent minor oral aphthous are selected from dermatology clinic by a dermatologist. Inclusion criteria include; patients who have 1 to 3 minor(size:1-8 millimeters) oral aphthous, with at least one relapse per month, . Exclusion criteria include :establishment of anemia, HIV or Behcet's syndrome and recipients of tetanus-diphtheria(Td) vaccine in the last five years. Obtaining informed consent from the patients ,they are divided into two groups based on random numbers. At the time of relapse , a common treatment prescribed to both groups.(1 mg Colchicine tablet per day for 5 days). At the beginning of the study , a single dose of Tetanus diphtheria(Td) vaccine for one of the groups and one milliliter of injections of vitamin B-6 for other group will be administered in the deltoid region. Each of them will be examined in the event of problems at the injection site. Subjects will be followed for 6 months. Before and after the study, the number of aphthous, its pain intensity and its size, the intervals between relapses and the time required for its healing will be assessed. The assessment will be done by the patients themselves. Lesion size in millimeter , pain with a score of 0 to 10 and the interval between relapses and time to recovery will be measured in days. Data will be analyzed after 6 months.
General information
Acronym
Tetanus diphtheria(Td) booster vaccine effect on recovery and relapse of recurrent minor oral aph
IRCT registration information
IRCT registration number:IRCT201501213989N1
Registration date:2016-01-03, 1394/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-03, 1394/10/13
Registrant information
Name
Shahram Habibzadeh
Name of organization / entity
ARUMS
Country
Iran (Islamic Republic of)
Phone
+98 45 3352 2083
Email address
s.habibzadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ardabil University of Medical science
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Tetanus diphtheria(Td) booster vaccine effect on recovery and relapse of recurrent minor oral aphthous.
Public title
Tetanus-diphtheria(Td) vaccine effect on recurrent minor oral aphthous.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 20 to 60 years old patients; who have 1 to 3 minor(1-8 millimeters) oral aphthous; with at least one relapse per month,
Exclusion criteria :establishment of anemia; HIV or Behcet's
syndrome ; recipients of tetanus-diphtheria(Td) vaccine in the last five years
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients are not aware of the content of what they injected . The nurse injected the drug is not aware of its content. Tracking the effectiveness of treatment is not aware of the type of treatment. Statistician is unaware of the content of the treatment groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Science
Street address
Kousar Minisity,Daneshghah Street,Ardabil
City
Ardabil
Postal code
5618985991
Approval date
2014-10-18, 1393/07/26
Ethics committee reference number
Arums.REC.93.52
Health conditions studied
1
Description of health condition studied
Recurrent Aphthous stomatitis( minor)
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Aphthous remission after treatment
Timepoint
At the beginning and end of the study
Method of measurement
Based on the judgment of those who have studied .Complete remission, partial remission, non-recovery
2
Description
The interval between the occurrence of aphthous
Timepoint
180 days
Method of measurement
One day(24 hours)
3
Description
The number of aphthous in each recurrence
Timepoint
180 days
Method of measurement
The number of aphthous
4
Description
Measuring pain intensity
Timepoint
180 days
Method of measurement
A score of 0 to ten according to one's own judgment
5
Description
Size of aphthous
Timepoint
180 days
Method of measurement
milimeter
Secondary outcomes
1
Description
Injection site reactions
Timepoint
Fifteen days after injection
Method of measurement
Physical examination in case of complications
Intervention groups
1
Description
In the intervention group, one mg of oral colchicine daily for 5 days plus a booster dose of ,Tetanus diphtheria(Td) vaccine is injected right deltoid region.
In case of recurrent aphthous, oral colchicine one mg daily for 5 days ,repeated.
Category
Treatment - Drugs
2
Description
In the control group one milligram oral colchicine daily for five days plus a half cc of vitamin B6 as a placebo in right deltoid area injected. In case of recurrent aphthous, oral colchicine one mg daily for 5 days ,repeated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Shahram Habibzadeh
Street address
Unit 3,No 31,Alley Resalat3,Street 13 Aban
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Ardabil University of Medical Sciences
Full name of responsible person
Mohsen Sagga.Director of Research and Technology
Street address
Kousar minisity ,Daneshghah street,Ardabil
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical science(ARUMS)
Full name of responsible person
Sharam Habibzadeh
Position
Associated professor in Infectious disease and Tropical Medicine