Efficacy of Yashthimadhu Ghrita Gandusha in the Management of Oral Submucous Fibrosis: A Randomized Controlled Trial
Not Applicable
- Conditions
- Health Condition 1: K135- Oral submucous fibrosis
- Registration Number
- CTRI/2024/05/067449
- Lead Sponsor
- Romita Gaikwad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients with age group between 20 and 60 years.
2. Clinically diagnosed patient of OSMF with Stage I, II, III.
3. Patients of both genders.
4. Patients who had not taken any treatment previously for OSMF.
5. Patients who are ready to leave the adverse habit of areca nut/betel quid/guthkha/kharra chewing and accepted to come for regular follow-up.
Exclusion Criteria
1.OSMF patients with co-existing other mucosal lesions
2.Extensive fibrosis with severe trismus with an inter incisal distance <15 mm (Stage IV OSMF).
3.OSMF patients with the coexisting systemic illness.
4.Pregnant women and lactating mothers.
5.OSMF patients with premalignant and malignant changes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To evaluate the alteration in Burning Sensation, Interincisal Mouth Opening and Cheek Flexibility associated with OSMF before and after the treatment with yashthimadhu ghrita gandusha. <br/ ><br>2.To evaluate alteration in Burning Sensation, Interincisal Mouth Opening and Cheek Flexibility associated with OSMF before and after the treatment with yashthimadhu ghrita gandusha with systemic lycopene. <br/ ><br>Timepoint: Pre-operative Burning Sensation, Interincisal <br/ ><br>Mouth Opening and Cheek Flexibility will be <br/ ><br>measured. These clinical parameters will be <br/ ><br>measured and recorded at baseline, 1st and 2nd month. Patients will be recalled after <br/ ><br>every 15 days for follow-up. <br/ ><br>
- Secondary Outcome Measures
Name Time Method To compare the effectiveness of yashthimadhu ghrita gandusha, systemic lycopene & topical triamcinolone acetonide in management of symptoms in OSMF. <br/ ><br>and To correlate efficacy of yashthimadhu ghrita gandusha according to clinical parameters of mouth opening, cheek flexibility & burning sensation. <br/ ><br>Timepoint: Pre-operative Burning Sensation, Interincisal <br/ ><br>Mouth Opening & Cheek Flexibility will be <br/ ><br>measured. These clinical parameters will be <br/ ><br>measured & recorded at baseline, 1st & 2nd month. Patients will be recalled after every 15 days for follow-up. <br/ ><br>