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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00723268

Enrollment

Registered

2008-07-28

Start date

2007-05-31

Completion date

Unknown

Last updated

2008-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Aphthae

Keywords

Oral ulcers

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.

Interventions

DRUGPrednisolone

5MG Prednisolone per day for 3 months

DRUGColchicine

0.5 MG Colchicine per day for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
frequency of ulcers	1 year

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026