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

NCT ID: NCT00723268

Last Updated: 2008-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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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

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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.

Conditions

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Oral Aphthae

Keywords

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Oral ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Prednisolone

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

5MG Prednisolone per day for 3 months

Colchicine

Group Type ACTIVE_COMPARATOR

Colchicine

Intervention Type DRUG

0.5 MG Colchicine per day for 3 months

Interventions

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Prednisolone

5MG Prednisolone per day for 3 months

Intervention Type DRUG

Colchicine

0.5 MG Colchicine per day for 3 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tehran

OTHER

Sponsor Role collaborator

Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mashhad Dental Research Center

Locations

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Mashhad Dental school

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

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Iran

Related Links

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http://www.mums.ac.ir/mcdr

Mashhad Dental Research Center

Other Identifiers

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286293

Identifier Type: -

Identifier Source: secondary_id

286293

Identifier Type: -

Identifier Source: org_study_id