Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae

Phase 2

• Conditions: Oral Aphthae
• Interventions: Drug: Colchicine; Drug: Prednisolone

• Registration Number: NCT00723268
• Lead Sponsor: Mashhad University of Medical Sciences

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.

Study Timeline

• Study Start: 2007-05
• Status Verified: 2008-07
• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-28
• Last Update Submitted: 2008-07-28
• Last Update Posted: 2008-07-29
• Primary Completion: 2008-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine	Colchicine	-
Prednisolone	Prednisolone	-

Primary Outcome Measures

Name	Time	Method
frequency of ulcers	1 year

Trial Locations

Locations (1)

Mashhad Dental school; 🇮🇷 Mashhad, Khorasan Razavi, Iran, Islamic Republic of