The efficacy of Rosa damascena extract in the treatment of recurrent aphthous stomatitis
Phase 2
- Conditions
- Recurrent aphthous stomatitis.Recurrent oral aphthae
- Registration Number
- IRCT138811063182N1
- Lead Sponsor
- Vice Chancellor for Research, Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
The presence of at least one aphthous ulcer measuring no more than 10 mm in diameter (formation no more than 48h), had no underlying systemic or immunologic disease such as rheumatoid arthritis and behcet syndrome. Patients were excluded if they had used NSAIDs, corticosteroids or other immunoregulatory agents within 1 month prior to the study or were less than 18 years of age.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Pain. Timepoint: on day 0 (baseline), days 4, 7, 11 and 14. Method of measurement: the Perceived Pain Rating Scale as introduced by Barker et al, 1991.;Change in Ulcer Size (mm2). Timepoint: on day 0 (baseline), days 4, 7, 11 and 14. Method of measurement: Ulcer size is measured by one examiner with the use of a calibrated dental probe with millimeter markings.;Change in number of Apthae. Timepoint: on day 0 (baseline), days 4, 7, 11 and 14. Method of measurement: Only ulcers which would come into contact with the rinse (i.e. in the oral cavity) will be considered.
- Secondary Outcome Measures
Name Time Method