Ayurvedic treatment of chronic mouth ulcer
Phase 2
Completed
- Conditions
- Health Condition 1: K135- Oral submucous fibrosis
- Registration Number
- CTRI/2022/07/043816
- Lead Sponsor
- CCRAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1.Patients aged between 18 years-60 years with OSMF are diagnosed clinically.
2.Patients who have not taken any treatment earlier for OSMF.
3.Patients who are ready to quit the habit of betel quid/ areca nut/ gutkha chewing and are willing for regular follow-ups.
Exclusion Criteria
1.Extensive fibrosis with severe trismus with an inter incisal
distance (IID) <15 mm
2.Pregnant and lactating mothers.
3.Disease is most advanced with premalignant and malignant changes
4.Generalized fibromatosis
5.Oral manifestation of scleroderma
6.Oral lichen planus
7.Pale oral mucosa of anemia mimicking blanching
8.Chronic debilitating conditions such as DM, HT, HIV, etc.
9.Patients not willing to give up addiction habits of Gutka, Panâ??Masala, tobacco, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a.Relief/ changes in the clinical manifestation of OSMF (stomatitis, palpable fibrotic band, tongue protrusion and inter-incisal distance) <br/ ><br>Timepoint: Duration of treatment: Medication for 84 days (12 weeks) <br/ ><br>Follow up: 04 weeks without medication <br/ ><br>Total study Duration: 6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method a.Changes in the real-time ultrasonography with high-frequency transducers, electromyography, and histopathological findings. <br/ ><br>b.Changes in the Quality of life of the patient <br/ ><br>Timepoint: baseline, and at the end of 84th day