Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified
Conditions
Interventions
Intervention1: Zuroor-e-Qula and Jawarish Amla sada: Jwarish amla sada to be taken with the dose of 6 grams, twice daily for 12 weeks. Drug Zuroor-e-Qula will be given with the instructions to apply o
Sponsors
Ministry of AYUSH
Eligibility
Inclusion criteria
Inclusion criteria: i. Patients with current or previous use of any form of smokeless tobacco and/or areca nut (any duration and frequency) ii. Patients having early-intermediate stage OSMF designated as Grade I and II by the grading system proposed by Kerr et al (29). iii. Patients willing to quit the habit of smokeless tobacco and/or areca nut. iv. Patients willing to accept regular follow-up protocol
Exclusion criteria
Exclusion criteria: i. Patients having advanced stage OSMF designated as Grade III, IV or V by the grading system proposed by Kerr et al. ii. Any significant medical condition such as scleroderma, anemic stomatitis and diabetes that would interfere with the safety, treatment or compliance with the protocol. Known diabetics or those with altered blood sugar values at the baseline assessment will be excluded from the study. iii. Patients with known allergy or contra-indication to any of the ingredients of the test drugs. iv. Patients already undergoing treatment for OSMF. v. Pregnant and lactating females. vi. Patients having concomitant pericoronitis or any other dental condition leading to trismus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Inter-incisal mouth opening b) Tongue protrusion c) Range of jaw movements d) Burning sensation/painTimepoint: every 2 weeks for 3 months: | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Adverse events or side effects reported after taking the Unani formulations. b) The impact of OSMF on quality of life of the patients will be assessed. c) Changes in the oxidative stress. d) Change in the nutritional status. e) Habit cessation success rate at 12-week follow-up.Timepoint: every 2 weeks for 3 months | — |
Countries
India
Contacts
Public ContactArpita Rai
Faculty of Dentistry, Jamia Millia Islamia
Outcome results
None listed