Comparison of Two Ayurvedic Ghee-Based Oral Treatments for Managing Mouth Tightness (Oral Submucous Fibrosis)

An Evaluation of Pratisarana with Yasthimadhu Ghrita and Panchgavya Ghrita in the Management of Oral Submucous Fibrosis- An Open-Label Randomized Comparative Clinical Study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103168

Enrollment

Registered

2026-02-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients with age group between 16 and 60 years will be included. 2. Diagnosed patients of Oral Submucosal Fibrosis (OSMF) will be included. 3. Patients of both sex will be included. 4. Clinically and/or histopathologically diagnosed cases of Oral Submucous Fibrosis. 5. Patients with restricted mouth opening (less35 mm). 6. Patients presenting with characteristic clinical signs and symptoms such as burning sensation mucosal stiffness blanching, and presence of fibrous bands. 7. Patients willing to provide written informed consent and comply with the study protocol

Exclusion criteria

Exclusion criteria: Patients who are contraindicated for pratisarana e.g.- unconscious poisoned, weak krusha person patient suffering from bleeding disorders and conjunctivitis will be excluded. 2. Extensive fibrosis with severe trismus with an Inter Incisal Distance (IID) Less15 mm will be excluded. 3. Disease is most advanced with premalignant and malignant changes will be excluded. 4. Generalized fibromatosis will be excluded. 5. Oral manifestation of scleroderma will be excluded. 6. Oral lichen planus will be excluded. 7. Pale oral mucosa of anemia mimicking blanching will be excluded. 8. Chronic debilitating conditions such as Diabetes Mellitus Hypertension HIV etc. will be excluded. 9. Individuals with known hypersensitivity to any component of the study drug. 10. Pregnant and lactating women.

Design outcomes

Primary

Measure	Time frame
Improvement in mouth opening (inter-incisal distance) after treatment with Yasthimadhu Ghrita and Panchgavya Ghrita.Timepoint: 30 day 60 day	—

Secondary

Measure	Time frame
Change in burning sensation (VAS). Change in cheek flexibility. Improvement in clinical grade of OSMF.Timepoint: 30 day 60 day	—

Countries

India

Contacts

Public ContactDr Siva Kumar CS

Glocal College Of Ayuvedic Medical Sciences

sivakumarcs33@gmail.com9447389253

Outcome results