A PROSPECTIVE, COMPARATIVE, RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF SNEC30 (CURCUMA LONGA) CAPSULES AND SNEC ORAL GEL TOPICAL APPLICATION IN THE TREATMENT OF ORAL SUBMUCOSAL FIBROSIS
Not Applicable
- Conditions
- Health Condition 1: null- ORAL SUBMUCOSAL FIBROSIS
- Registration Number
- CTRI/2018/02/011939
- Lead Sponsor
- Arbro Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patient or his legally accepted representative is willing to give informed consent.
2.Patient is in the age range of 18-65 yrs.
3.Patient clinically diagnosed with OSF (diagnosed on the basis of reduction in interincisal distance on maximum mouth opening and palpable fibrous bands involving oral mucosa).
4.Patient is willing to discontinue the use of tobacco in any form or areca 1-month prior to the commencement of the treatment.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in burning sensation. <br/ ><br>Improvement in mouth opening. <br/ ><br>Timepoint: reduction in burning sensation and mouth opening will be checked at enrollment day , day 28, day 56 and day 84. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Safety and tolerability of the drug will be evaluated on the basis of occurrence / non-occurrence, type, frequency and duration of drug-related adverse reactionsTimepoint: Safety and tolerability of the drug will be evaluated throughout the study.