Evaluation of efficacy of Moringa leaves extract in treatment of Oral Submucous Fibrosis in comparison with standard treatment protocol – A Randomised Controlled Trial
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Dr Poonam Ambhore
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in clinical parameters (burning sensation, mouth opening, tongue protrusion, cheek flexibility)
Overview
Brief Summary
This pilot study aims to assess the efficacy of Moringa oleifera leaf extract in different forms (tablet, powder, and 4% gel) in the management of Oral Submucous Fibrosis (OSMF). A total of 30 clinically diagnosed patients will be randomly divided into three groups and treated for 30 days. Group I will receive Moringa tablets + SM-FIBRO + Moringa gel, Group II will receive Moringa powder + SM-FIBRO + Moringa gel, and Group III (control) will receive SM-FIBRO + Turbocort gel. Clinical improvements in burning sensation, mouth opening, tongue protrusion, and cheek flexibility will be evaluated at baseline, Day 10, Day 20, and Day 30, followed by a 1-month follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 15.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Clinically diagnosed OSMF Stage I to III by Khanna and Andrade classification
- •History of areca nut, gutkha, kharra, pan masala chewing
- •Willing to participate and give informed consent.
Exclusion Criteria
- •Habit cessation in the last 6 months
- •Stage IV OSMF
- •Systemic illness or medications
- •Allergy to Moringa or herbal drugs
- •Already undergoing treatment for OSMF.
Outcomes
Primary Outcomes
Change in clinical parameters (burning sensation, mouth opening, tongue protrusion, cheek flexibility)
Time Frame: from baseline to Day 30
Secondary Outcomes
- Sustained improvement in symptoms at 1-month follow-up after treatment completion
Investigators
Dr Tapasya Karemore
Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Higna road, NAGPUR