Effect of combined Ayurvedic treatment using herbal medicine and mouth application medicines on improving mouth opening Reducing Burning sensation and Relieving discomfort in patients with oral submucous fibrosis

EVALUATION Of THE ADD ON EFFECT OF SAPTHACHADADI KASHAYA ORALLY ALONG WITH DARVYADI KWATHA GANDUSHA AND DARVI RASAKRIYA PRATISARANA IN TRIDOSHAJ SARVASARA MUKHAPAKA(ORAL SUBMUCOUS FIBROSIS) AN OPEN LABEL DOUBLE ARM RANDOMISED CONTROLLED CLINICAL TRIAL - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110061

Enrollment

Registered

2026-05-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients presenting with sign and symptoms of sarvasara mukharoga. 2. The Patient having clinical sign and symotoms of OSMF 3. Patient fit for Gandusha. 4. Patient fit for Pratisarana karma. 5. Patient clinically diagnosed with osmf Stage I to OSMF Stage III based on the degree of mouth opening.

Exclusion criteria

Exclusion criteria: 1. Patients exhibiting severe trismus with an inter-incisal distance (IID) of less than 15 mm due to extensive fibrosis. 2. Cases where the disease has progressed to include pre-malignant or malignant transformations. 3. Presence of widespread fibromatosis. 4. Oral involvement in systemic conditions like scleroderma. 5. Individuals diagnosed with oral lichen planus. 6. Infective bacterial,viral ,fungal ,traumatic- medical chemical thermal,radiaton,eosinophilic ulcer,injury, 7. Associated with systemic disease-gastrointestinal tract disease ,diabetic ulcer,syphilitic ulcer,HIV infection 8. Participants younger than 18 years or older than 60 years, regardless of gender. 9. Individuals unwilling to discontinue the use of addictive substances like gutka, pan masala, tobacco, etc. 10.Associated with dermatological disease Lichen planus,chronic discoid lupus erythematous ,vesiculobullous disease or neoplastic :squamous cell carcinoma ,other malignant neoplasms

Design outcomes

Primary

Measure	Time frame
1.Change in inter incisial distance (in mm).Timepoint: 0th day, 7th day, 14th day and 21st day	—

Secondary

Measure	Time frame
1.Change in quality of life. 2.Change in symptoms like pain, burning sensation and intolerance to spicy food. Timepoint: 0th day, 7th day, 14th day and 21st day	—

Countries

India

Contacts

Public ContactDr Mohini S Bhadauriya

All India Institute of Ayurveda

pankajkundal1146@gmail.com7291887810

Outcome results