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A Study To See How Effective Moringa Leaf Extract Is In Treating Oral Submucous Fibrosis Compared To Standard Treatment

Evaluation of efficacy of moringa leaves extract in treatment of oral submucous fibrosis in comparison with standard treatment protocol - A randomized controlled trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090790
Enrollment
80
Registered
2025-07-11
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: moringa tablet, moringa powder and moringa gel: moringa oleifera leaves extract given in 3 different forms Intervention2: group 1 - Moringa Tablet + Standard Treatment + 4% Moringa Gel:

Sponsors

Poonam Ambhore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with clinically diagnosed Oral Submucous Fibrosis (OSMF) classified as Stage II-III (based on classification of Khanna and Andrade 1995) 2.Patients with known history of areca nut, gutkha, kharra, pan masala chewing. 3.Patients who are willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1.Patients who have left the habit in the last 6 months or more. 2.Patients with OSMF Stage IV. 3.Patients with any systemic diseases. 4.Patients on any medications. 5.Patients with history of hypersensitivity to any drug or natural plants including moringa. 6.Patients who are already under the treatment of OSMF.

Design outcomes

Primary

MeasureTime frame
Improvement in clinical parameters of Oral Submucous Fibrosis including burning sensation on visual analogue scale, mouth opening, tongue protrusion, and cheek flexibility. Timepoint: baseline, day 10, day 20, day 30, day 60

Secondary

MeasureTime frame
Sustained improvement in clinical parameters during follow-up Timepoint: 3-month follow-up after Day 30

Countries

India

Contacts

Public ContactPoonam Ambhore

Ranjeet Deshmukh Dental College and Research Centre, Digdoh hills, Higna Road Nagpur

poonam4997@gmail.com8830081564

Outcome results

None listed

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