To find out if a new drug in combination with the present drug is better than the present drug given alone for treatment of Oral Sub mucous fibrosis.
Not Applicable
- Conditions
- Health Condition 1: L948- Other specified localized connective tissue disorders
- Registration Number
- CTRI/2020/12/029859
- Lead Sponsor
- Dr Neha Anil Patil
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Clinical and functionally classified stage I
and stage II OSMF (Oral Sub mucous Fibrosis)
patients.
2. Age â?? 14- 45 yrs.
3. Patients not under any intervention for the
same will be included.
Exclusion Criteria
1. Clinical and functionally stage III, IV A, IV
B and V OSMF patients.
2. Any other Oro-mucosal lesions/conditions
3. Patients who are under treatment for the
OSMF
4. Diagnosed cases not ready for participation
in the study
5. Patients suffering from medically
compromised conditions.
6. Patients who are receiving or have received
any form of therapy in the past six-month
period will be excluded.
7. Children (less than 13 yrs) and pregnant and
lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the efficacy of combination therapy over present monotherapy for treatment of Stage I and II Oral Submucous Fibrosis Patients.Timepoint: 1.5yrs
- Secondary Outcome Measures
Name Time Method To assess the change in the Quality of life of patients after treatment for Oral Submucous FibrosisTimepoint: 1.5 yrs