A Multi center, Phase II, Randomized, Double –Blind, Placebo controlled, Chemoprevention Study to Determine the Clinical Efficacy and Safety of Curcumin in Oral Premalignant Lesions/Cervical cancer. |
| Sponsored by: |
| Department of Biotechnology |
| Primary Objective: |
To evaluate the clinical efficacy and safety of oral BCM-95 therapy for period of 6 months in subjects with oral premalignant lesions (OPL) by: |
- Clinical response (reduction in size of all lesions, prevention of malignant transformation in the index lesion and occurrence of any new lesions) |
| - Histological response (change in histological grade) |
| Secondary Objective: |
| - To investigate in-vivo modulation of Nuclear Factor Kappa B (NF-kB) and biomarkers, by BCM-95 |
| - To identify pharmacokinetics of oral administration of BCM-95 |
| Study Design: |
An estimated 102 subjects with oral premalignant lesions/cervical cancer will be enrolled over 12 month period per center. All subjects will be required to meet study eligibility criteria and sign informed consent. After initial biopsy, subjects will be randomized to either BCM-95 3.6g/day bid or placebo bid for 6 months. At the end of the 6 months of treatment the lesion will be measured for the primary assessment of clinical pathologic response. Ten patients will be enrolled at the AIMS for the pharmacokinetics assay for long term use of BCM-95.
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Those patients with clinical partial response will continue the BCM-95 therapy for another 6 months. The other patients will be followed for 6 more months to assess the durability of the response. Patients who develop malignant transformation will be withdrawn from the study after biopsy confirmation. The study is planned to complete accrual of patients in 12 months and to be completed in 24 months period. |
Human Clinical Study to Assess the Efficacy and Safety of BCM-95 in the Management of the Signs and Symptoms of Active Rheumatoid Arthritis |
| Study Objective: |
The purpose of this study is to evaluate the safety and effectiveness of BCM-95 in patients with active Rheumatoid Arthritis assessed by the percentage change from baseline in study parameters. Patients will be from age of 18-65 years who are recently diagnosed to have rheumatoid arthritis according to revised 1987 ACR criteria for the classification of rheumatoid arthritis. Patients with RA functional class of I and II will be enrolled. |
| Study Design: |
This is a single center, randomized, trial designed to determine the safety and effectiveness of twice daily and thrice daily oral therapy of BCM-95 500mg capsule for 8 weeks in patients with active Rheumatoid Arthritis. |
| Study Population: |
The calculated sample size is 20. A total of 26 patients with active RA will be selected and enrolled to account for the dropouts. All subjects will have to meet the study eligibility criteria. Group A will get 500mg of BCM-95 twice a daily in morning and evening after food with water. Group B will get 500mg of BCM-95 thrice a daily in morning, afternoon and evening after food with water |
ASSAY OF NMDA RECEPTOR INHIBITORY PROPERTY OF CURCUMIN VERSUS (BCM-95). |
| Study Design: |
The proposed study involves a cell culture based assay for NMDA receptor activity. NMDA receptor with NR1 and NR2B subunits will be expressed along with a sensor protein in the HEK-293 cells. Two assays will be performed in which inhibition on NMDA receptor will be checked. |
- The NR1/NR2B receptor upon expression causes death of HEK-293 cells. To prevent this, a known inhibitor of NMDA receptor is included in the culture medium. The test compounds will be tested for their ability to substitute the known inhibitor in supporting cell survival. If it is successful, then it is likely to have inhibitory action on NMDA receptor. |
- The activity of NMDA receptors is detected using a fluorescence microscopy based assay. Inhibition on the activity of the receptor will be detected by this assay also. |
| Study centre : |
| Department of Neurobiology, Rajiv Gandhi Centre for Biotechnology P. O. Thiruvananthapuram. |
| Time Period : |
| 6 months |
