Health Condition 1: D10- Benign neoplasm of mouth and pharynx
Conditions
Interventions
Intervention1: 1. Yashtimadhu
2. Haldi
3. Ghee: The medicine used in the study shall comply the pharmacopoeial and quality standards. Medicinal Mouth wash/Rinse (Gandusha):It will consist of combinati
Sponsors
Ministry of AYUSH
Eligibility
Inclusion criteria
Inclusion criteria: 1. Volunteers with diagnosed cases of oral sub mucous fibrosis clinically. 2. Systemically healthy volunteers will be included. 3. Patients willing to give written informed consent to participate in the study for 3 months excluding 2 weeks without drug for follow-up.
Exclusion criteria
Exclusion criteria: 1. Persons not willing to participate in the study. 2. Smokers, tobacco and/ or pan masala chewers, not ready to quit the habit. 3. Persons having clinical evidence of malignant change, extension of the disease either onto the pharynx or floor of mouth. 4. Pregnant and lactating women. 5. Persons having systemic diseases or conditions, which can be worsened by the use of steroids. 6. Persons already undergoing some OSMF treatment. 7. H/o hypersensitivity to any of the control or the trial drug or any of its ingredients. 8. Patients who have completed participation in any other clinical trial during the past six (06) months. 9. Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pretreatment and post treatment inter-incisal distance (in millimeters) to assess mouth opening.Timepoint: Time frame: from base line to end of 14th days, 28th days, 42nd days, 56th days, and first follow up after 2 week and second after one month after withdrawal of the drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in scores of subjective Symptoms e.g. mouth opening, consistency of the mucosa on palpation, Burning sensation, colour.Timepoint: Time frame: from base line to end of 14th days, 28th days, 42nd days, 56th days, and first follow up after 2 week and second after one month after withdrawal of the drug. | — |
Countries
India
Contacts
Public ContactDr Uma Shanker Pal
King George medical University
Outcome results
None listed