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

• Sponsor: Mashhad University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00723268
• Collaborator: University of Tehran (Other)
• Enrollment: 30
• Location: 1
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Aphthae	Drug: Prednisolone; Drug: Colchicine	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
• Study Start Date: May 1, 2007
• Anticipated Primary Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prednisolone	Drug: Prednisolone; 5MG Prednisolone per day for 3 months
Active Comparator: Colchicine	Drug: Colchicine; 0.5 MG Colchicine per day for 3 months

Outcome Measures

Primary Outcome Measures

1. frequency of ulcers [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mashhad Dental school	Mashhad	Khorasan Razavi	Iran, Islamic Republic of	91735

Sponsors and Collaborators

• Mashhad University of Medical Sciences
• University of Tehran

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00723268
• Other Study ID Numbers: 286293; 286293
• First Posted: Jul 28, 2008
• Last Update Posted: Jul 29, 2008
• Last Verified: Jul 1, 2008

• Keywords provided by , ,: Oral ulcers
• Additional relevant MeSH terms: Stomatitis, Aphthous; Prednisolone; Colchicine

Study Results

No Results Posted as of Jul 29, 2008