This trial is active, not recruiting.

Condition oral aphthae
Treatments prednisolone, colchicine
Phase phase 2
Sponsor Mashhad University of Medical Sciences
Collaborator University of Tehran
Start date May 2007
End date August 2008
Trial size 30 participants
Trial identifier NCT00723268, 286293


The purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
(Active Comparator)
5MG Prednisolone per day for 3 months
(Active Comparator)
0.5 MG Colchicine per day for 3 months

Primary Outcomes

frequency of ulcers
time frame: 1 year

Eligibility Criteria

Male or female participants from 15 years up to 60 years old.

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

Additional Information

Official title Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by Mashhad University of Medical Sciences.