Back to resultsEvaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
Primary Purpose
Oral Aphthae
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Prednisolone
Colchicine
Sponsored by
About this trial
This is an interventional treatment trial for Oral Aphthae focused on measuring Oral ulcers
Eligibility Criteria
Inclusion Criteria:
- Confirmation of clinical diagnosis of aphthae
- Having the experience of oral aphthae at least once in a month
- Two weeks wash out periods after the last treatment
Exclusion Criteria:
- History of any systemic disease
- Using drugs which affect immune system
- Pregnancy and breast feeding
- Aphthous related syndromes
Sites / Locations
- Mashhad Dental school
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Prednisolone
Colchicine
Arm Description
Outcomes
Primary Outcome Measures
frequency of ulcers
Secondary Outcome Measures
Full Information
NCT ID
NCT00723268
First Posted
July 24, 2008
Last Updated
July 28, 2008
Sponsor
Mashhad University of Medical Sciences
Collaborators
University of Tehran
1. Study Identification
Unique Protocol Identification Number
NCT00723268
Brief Title
Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
Official Title
Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Mashhad University of Medical Sciences
Collaborators
University of Tehran
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae.
Detailed Description
Treatment of recurrent aphthous stomatitis (RAS) remains, to date, empirical and non-specific. The main goals of therapy are to minimize pain and functional disabilities as well as decrease inflammatory reactions and frequency of recurrences.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Aphthae
Keywords
Oral ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prednisolone
Arm Type
Active Comparator
Arm Title
Colchicine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
5MG Prednisolone per day for 3 months
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
0.5 MG Colchicine per day for 3 months
Primary Outcome Measure Information:
Title
frequency of ulcers
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Confirmation of clinical diagnosis of aphthae
Having the experience of oral aphthae at least once in a month
Two weeks wash out periods after the last treatment
Exclusion Criteria:
History of any systemic disease
Using drugs which affect immune system
Pregnancy and breast feeding
Aphthous related syndromes
Facility Information:
Facility Name
Mashhad Dental school
City
Mashhad
State/Province
Khorasan Razavi
ZIP/Postal Code
91735
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
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