A randomized, double-blind, active controlled, parallel-group, clinical study to evaluate the efficacy and safety of poly herb gel in treatment of clinically diagnosed stage I and Stage II Oral Sub Mucous Fibrosis.
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 1. The mean improvement in interincisal mouth opening
Study Overview
Brief Summary
There is multi drug concept in treating OSMF and use of steroids will have long term disadvantage. Disadvantage of intralesional injections can form more fibrous bands, mucosal atrophy, difficulty to deposit sufficient quantities into gingival lesions, injection are painful and intrusive. Herbal medicine has been used for thousands of years to treat a variety of health issues. It’s generally gentler on the body and has fewer side effects than prescription drugs, and it can also be more affordable. The World Health Organization guidelines define herbal medicines as finished, labeled medicinal products containing an active ingredient, i.e., obtained from the aerial or underground parts of botanicals or other plant materials or their combination.4 Hence using poly herb has medicinal or rasaya properties provide a synergestic effect in the treatment. It is also safer and more potent in long term. Starting a poly herbal gel improves prognosis of the disease
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patient who are clinically diagnosed with OSMF aged between 18 to 65 years
- •OSMF with grade I, and II will be included without any underlying comorbidities
- •Patients who are ready to quit the habit of betel quid/ areca nut/ gutkha chewing and are willing for regular follow-ups.
- •Must be willing and able to give informed consent and comply with the study procedures.
Exclusion Criteria
- •Debilitating diseases such as carcinoma.
- •Patients contraindicated for steroids.
- •Patients with other mucosal disorders with clinical features same as OSF (such as: trismus due to Temporomandibular Joint Dysfunction, pericoronitis, space infection, history of surgery or trauma, systemic sclerosis, amyloidosis, iron deficiency anemia, radiation therapy).
- •Patients who were under treatment or have had already undergone treatment for OSF.
- •The patients with history of hypersensitivity to hyaluronidase.
- •Patients with history of hypersensitivity to herbal drugs
- •Patients with OSMF of Grade III and IV
- •Pregnant and lactating mothers.
- •Disease is most advanced with premalignant and malignant changes.
Outcomes
Primary Outcomes
1. The mean improvement in interincisal mouth opening
Time Frame: Day 0 Day 30 Day 60 and Day 90
2.The mean improvement in cheek flexibility
Time Frame: Day 0 Day 30 Day 60 and Day 90
3.The mean improvement in tongue protrusion
Time Frame: Day 0 Day 30 Day 60 and Day 90
Secondary Outcomes
- 1. Pain VAS(2. OSMF questionnaire)
- Salivary Biomarkers (SImmunoglobulins)(Haematology Biochemistry)
Investigators
Dr G Roopashri
M R Ambedkar medical college and Hospital