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Status unknownNCT00723268Updated Jul 29, 2008

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

A Phase 2 interventional study of Prednisolone and Colchicine in Oral Aphthae, sponsored by Mashhad University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 15 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-07-29.

Sponsored by Mashhad University of Medical Sciences · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
15 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Oral Aphthae

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Keywords

  • Oral ulcers
03

In context

Stomatitis, Aphthous

61 studies on the registry are indexed under Stomatitis, Aphthous; 16 are open to participants now.

This study's planned enrollment of 30 is below the median of 48 across 53 interventional studies indexed under Stomatitis, Aphthous.

Browse Stomatitis, Aphthous studies →

Lead sponsor

Mashhad University of Medical Sciences is the lead sponsor of 90 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • History of any systemic disease
  • Using drugs which affect immune system
  • Pregnancy and breast feeding
  • Aphthous related syndromes
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Prednisolone

    Drug: Prednisolone

  • Active comparator
    Colchicine

    Drug: Colchicine

Interventions

  • DrugPrednisolone

    5MG Prednisolone per day for 3 months

  • DrugColchicine

    0.5 MG Colchicine per day for 3 months

06

What researchers measure

Primary outcomes

  1. frequency of ulcers

    Time frame: 1 year

07

Study locations

1 site
  • Mashhad Dental school
    Mashhad, Khorasan Razavi 91735, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00723268
Lead sponsor
Mashhad University of Medical Sciences
Collaborators
University of Tehran
First posted
Jul 28, 2008
Start date
May 2007
Primary completion
Aug 2008 (estimated)
Last update
Jul 29, 2008

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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