Health Condition 1: M265- Dentofacial functional abnormalities
Conditions
Interventions
Intervention1: Svarnsaathi, 4g sachets: The product is a natural product and intended for the mild to moderate oral sub-mucous fibrosis symptoms relief.
To be taken orally once in morning daily for 3
Sponsors
BigBrother Nutra Care Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and females aged >=18 2. Participants (or legally acceptable representative) who are voluntarily willing to participate in the study and sign/thumb-stamped the informed consent document 3. Willingness to use the assigned products according to instructions and other study steps, availability for appointments, and likelihood of completing the clinical trial. 4. No concurrent participation in any other oral care clinical study. Oral Inclusion Criteria 1a. Moderate oral submucous fibrosis (defined interincisal distance equal to or greater than 20mm but less than 35mm AND at least one of the following clinical features): a) fibrous banding (ie stiff/leathery mucosa) b) blanching of mucosa c) burning symptoms ( >20mm on items 1 or 2 on oral symptoms VAS) 1b. Mild oral submucous fibrosis (defined as interincisal distance equal to or greater than 35mm but less than 45mm AND at least one of the following clinical features) a) fibrous banding (ie stiff/leathery mucosa) b) blanching of mucosa c) burning symptoms ( >20mm on items 1 or 2 on oral symptoms VAS)
Exclusion criteria
Exclusion criteria: 1. Current or prior history of oral cancer. 2. Radiation therapy to the head or neck region. 3. No recent treatment for OSMF, particularly steroids (within 3 months). 4. Medical conditions which in the opinion of the investigator may compromise the subjectâ??s health or the outcome of the study. (eg ischemic heart disease (angina, recent MI, or connective tissue diseases). 5. Observable oral conditions (eg odontogenic infections) contributing to trismus which in the opinion of the investigator may compromise the subjectâ??s health or the outcome of the study. 6. Women who are, or will become, pregnant or lactating during the course of the study. 7. Participants who are not willing to give their consent to participate in the trial Inability to obtain informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measure of mouth opening will be assessed by Vernier calipers measuring inter incisal distanceTimepoint: week0 week4 week 8 week12 | — |
Secondary
| Measure | Time frame |
|---|---|
| The measure of oral symptoms particularly oral burning will be assessed by visual analogue scaleTimepoint: week0 week4 week 8 week12 | — |
Countries
India
Contacts
Public ContactDivya C
BioAgile Therapeutics Pvt Ltd
Outcome results
None listed