Health Condition 1: null- Oral Premalignant lesions
Conditions
Interventions
Intervention1: Curcumin capsules: Each subject will receive 3 capsules twice in a day after food. (strength of each capsule is 600 mg and total 3.6/day)
Control Intervention1: Placebo capsules: Each s
Sponsors
Department of Biotechnology Ministry of Science and Technology
Eligibility
Inclusion criteria
Inclusion criteria: The index lesion should be 15 mm2 or greater in size that has not been biopsied in the past 6 weeks. The subject meets the following laboratory eligibility criteria during a time not to exceed 4 weeks prior to randomization. Hemoglobin level above or equal to 8 g %. Zubrod score of 0 to 2 WBC count > 3,000 mm3. Platelets count > 125,000 m3. Total bilirubin, AST (SGOT) and ALT (SGPT) Urea Serum creatinine The subject is willing and able to fully participate for the duration of the study. If the subject is female and of childbearing potential (women are considered not of childbearing potential if they are at least two years postmenopausal and/or surgically sterile), and she has been using adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since her last menses and will use adequate contraception during the study, -AND is not lactating, -AND has a documented negative urine beta hCG within 14 days prior to randomization. The subject has discontinued any other chemo-preventive therapy at least 3 months prior to the baseline visit and all toxicities have been fully resolved. The subject has signed and dated the informed consent statement. If applicable, the subject has been counseled on tobacco cessation.
Exclusion criteria
Exclusion criteria: The subject has had chemotherapy, immunotherapy, hormonal therapy (other than HRT for menopause), or radiation therapy within 3 weeks of the baseline visit.  The subject has not recovered from the acute toxic effects of chemotherapy, immunotherapy, hormonal therapy, or radiation therapy.  The subject will need concurrent chemotherapy, radiotherapy, hormonal (other than HRT for menopause), or immunotherapy during the time of study.  The subject participated in the study previously and was withdrawn.  All subjects considered for participation and found ineligible will be recorded in the Screen Failure Log. Subject confidentiality is maintained, but reason for exclusion will be recorded.  Subjects with potential behavioral and cognitive impairment.  Previous history of radiotherapy for oral or oropharyngeal cancer  Subjects diagnosed with oral submucous fibrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with Final Complete Response (CR) or Final Partial Response (PR)assessed both on clinical response and histological responseTimepoint: based on the evaluation at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events - incidence, frequency and severityTimepoint: Followed throughout the study;Correlations among the biomarkers and between the biomarkers and response rate will be evaluatedTimepoint: Repeated measurements of biomarkers over the time from baseline to 6, 12 months post-treatment will be analyzed | — |
Countries
India
Contacts
Public ContactRakesh Naranbhai Dadhania
Director - AIMS, Cochin
Outcome results
None listed