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
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Efficacy of intervention on signs and symptoms of Oral Submucous Fibrosis (OSMF).
Study Overview
Brief Summary
The trial is randomized clinical trial to evaluate the efficacy of Madhupippalyadi Yoga Pratisarana, Nishadi Taila Kavala with and without Rasayana Yoga Orally in the management of Oral Submucous Fibrosis (OSMF). Total 30 patients will be enrolled in the study. Selected patients will be divided into two groups on the basis of computer generated randomization. In the study Madhupippalyadi Yoga Pratisarana 3gm. BD,Nishadi Taila 15ml BD locally as kavala will be given before meal with Rasayana Yoga 6gm BD before meal with sahpana of madhu and ghrut for 2 month . In another group only Madhupippalyadi Yoga Pratisaran 3gm. BD, Nishadi Taila 15ml BD locally as kavala will be given before meal without Rasayana Yoga for 2 months. Follow up will be carried out at 15 days interval for 2 month on routine medicine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
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
- •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.
- •9.The patients taking any other systemic drugs which can alter the result of study.
Outcomes
Primary Outcomes
Efficacy of intervention on signs and symptoms of Oral Submucous Fibrosis (OSMF).
Time Frame: during the treatment period at baseline | 8 Weeks
Secondary Outcomes
- Improvement in the quality of life of the patient Assessment of recurrence of signs & symptoms of Oral Submucous Fibrosis (OSMF) during(follow up period)
Investigators
Tamanna Kumari
ITRA Jamnagar