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

Mashhad University of Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Oral Aphthae

Treatments: Drug: Colchicine; Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00723268

286293

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Prednisolone

Active Comparator group

Treatment:

Drug: Prednisolone

Colchicine

Active Comparator group

Treatment:

Drug: Colchicine