A Pilot Study on the Use of Moringa Leaf Extract to Improve Symptoms in People with Oral Submucous Fibrosis

Evaluation of efficacy of Moringa leaves extract in treatment of Oral Submucous Fibrosis in comparison with standard treatment protocol A Randomised Controlled Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091159

Enrollment

Registered

2025-07-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: standard drug + intervention: Moringa Tablet (1000 mg OD) + SM-FIBRO (OD) + 4% Moringa gel (TID) Intervention2: Standard drug + Intervention drug: Moringa Powder (2 g in water OD) + SM

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinically diagnosed OSMF Stage I to III by Khanna and Andrade classification 2. History of areca nut, gutkha, kharra, pan masala chewing 3. Willing to participate and give informed consent

Exclusion criteria

Exclusion criteria: 1. Habit cessation in the last 6 months 2. Stage IV OSMF 3. Systemic illness or medications 4. Allergy to Moringa or herbal drugs 5. Already undergoing treatment for OSMF

Design outcomes

Secondary

Measure	Time frame
Sustained improvement in symptoms at 1-month follow-up after treatment completion Timepoint: Baseline, day 10, day 20, day 30 , follow up after 1 month	—

Primary

Measure	Time frame
Change in clinical parameters (burning sensation, mouth opening, tongue protrusion, cheek flexibility) Timepoint: from baseline to Day 30	—

Countries

India

Contacts

Public ContactDr Poonam Ambhore

Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Higna road, NAGPUR - 440019

drtapasyavk@gmail.com08830081564

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026