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

Oral Aphthae Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00723268
• Other study ID #: 286293
• Secondary ID: 286293
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 24, 2008
• Last updated: July 28, 2008
• Start date: May 2007

Study information

• Verified date: July 2008
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oral Aphthae
• Stomatitis, Aphthous

Intervention

Drug:
• Prednisolone
5MG Prednisolone per day for 3 months
• Colchicine
0.5 MG Colchicine per day for 3 months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad Dental school	Mashhad	Khorasan Razavi

Sponsors (2)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences	University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of ulcers		1 year	Yes

External Links

•   Mashhad Dental Research Center