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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by Mashhad University of Medical Sciences.
Recruitment status was:  Active, not recruiting
University of Tehran
Information provided by:
Mashhad University of Medical Sciences Identifier:
First received: July 24, 2008
Last updated: July 28, 2008
Last verified: July 2008
The purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae.

Condition Intervention Phase
Oral Aphthae Drug: Prednisolone Drug: Colchicine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae

Resource links provided by NLM:

Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • frequency of ulcers [ Time Frame: 1 year ]

Estimated Enrollment: 30
Study Start Date: May 2007
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
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
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Please refer to this study by its identifier: NCT00723268

Iran, Islamic Republic of
Mashhad Dental school
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735
Sponsors and Collaborators
Mashhad University of Medical Sciences
University of Tehran
  More Information

Additional Information:
Responsible Party: Mashhad University of Medical Science, Mashhad Dental Research Center Identifier: NCT00723268     History of Changes
Other Study ID Numbers: 286293
Study First Received: July 24, 2008
Last Updated: July 28, 2008

Keywords provided by Mashhad University of Medical Sciences:
Oral ulcers

Additional relevant MeSH terms:
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on July 19, 2017