Ayurvedic treatment of Oral Submucous Fibrosis (Unable to open mouth) with Madhupippalyadi Yoga Pratisarana (local application over gums lepa ),Nishadi Taila Kavala (garggle) with and without Rasayana Yoga (internally oral medicine)

Role of Madhupippalyadi Yoga Pratisarana, Nishadi Taila Kavala with and without Rasayana Yoga Orally in the management of Oral Submucous Fibrosis - An Open Labelled Randomized Comparative Clinical Trial

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084806

Enrollment

Registered

2025-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: O- Medical and Surgical

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age Group between 18- 60 year old 2.The patient having cinical signs and symptoms blanching and stiffness of oral mucosa , altered taste sensation,altered salivation, repeated vesicular eruption and ulceration on buccal mucosa , palate and pillars , burning sensation in mouth , intolerance to hot and spicy foods, difficulty in opening mouth 3.Interincisal distance of more than 15mm 4.Patient Having minimum two Clinical symptoms of Oral Submucous Fibrosis will be included 4.Primary symptom is Blanching and stiffness of oral mucosa along with any other symptoms of osmf

Exclusion criteria

Exclusion criteria: 1.Age less than 18-60 years 2.Extensive Fibrosis of oral mucosa severe trismus with an interincisal distance of less than 15mm 3.Disease most advanced with premalignant and malignant changes. 4.Oral manifestation of scleroderma. 5.Oral lichen planus. 6.Chronic debilitating conditions like DM, HTN. 7.Patients not willing to give up habits of gutkha, pan masala, mawa, tobacco, betel quid or betel nut chewing. 8.Pregnant women should be excluded. 9.The patients taking any other systemic drugs which can alter the result of study.

Design outcomes

Primary

Measure	Time frame
Efficacy of intervention on signs and symptoms of Oral Submucous Fibrosis (OSMF).Timepoint: during the treatment period at baseline 8 Weeks	—

Secondary

Measure	Time frame
Improvement in the quality of life of the patient Assessment of recurrence of signs & symptoms of Oral Submucous Fibrosis (OSMF) during follow up periodTimepoint: During follow up period on 15th ,30th,45th & 60th day	—

Countries

India

Contacts

Public ContactProf Dr D B Vaghela

ITRA Jamnagar

drvaghela@rediffmail.com9825407899

Outcome results