Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue
Conditions
Interventions
Intervention1: Lycopene capsule
Tocotrienol (50 percent) tablet: Lycopene capsule 5 mg orally, twice daily (after meals) and Tocotrienol (50percent) tablet 400 mg orally, once daily (after meals). Tot
Sponsors
Dr Aditi Roy
Eligibility
Inclusion criteria
Inclusion criteria: Age group 20 to 50 years, clinically and histologically diagnosed homogeneous leukoplakia (white patch not attributable to any other disease), having measurable lesions with minimum lesion size greater than or equal to 1 cm in greatest dimension, no history of prior topical or systemic treatment for oral leukoplakia in the last 3 months, willing to discontinue tobacco or areca nut habits during the study period, willing to attend regular follow-up visits throughout the study, and provide written informed consent.
Exclusion criteria
Exclusion criteria: Clinical or histopathological evidence of oral carcinoma at the lesion site; presence of other oral potentially malignant disorders; known hypersensitivity to beta carotene, lycopene, tocotrienol, or vitamin E derivative components; current or recent use of antioxidant therapy within the last 3 months; pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lesion size (square cm): Lesion size will be measured clinically using a digital vernier caliper and area will be calculated from maximum length and width.Timepoint: Assessments will be performed at baseline, every 15 days during the 3-month treatment period, and monthly during the 3-month post-treatment follow-up period up to 6 months.Baseline, 15 days, 1 month, 1.5 months, 2 months, 2.5 months, 3 months (end of treatment), 4 months, 5 months, and 6 months (end of follow-up). | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects of intervention, if any reported by patient. In case of any untoward reaction such as nausea, vomiting, headache, rash, allergy, etc., the patients were asked to report immediately. Timepoint: Assessment of adverse effects will be performed at baseline, every 15 days during treatment, monthly during follow-up, & immediately upon occurrence of any adverse event. | — |
Countries
India
Contacts
Public ContactDr Ashita Kalaskar
Government Dental College and Hospital, Nagpur
Outcome results
None listed