Health Condition 1: null- Prevention of cancer following surgery
Conditions
Interventions
Intervention1: RV CAPS: Each capsule Contains: Draksha Extract (Vitis vinifera), Amalaki Extract (Phyllanthus emblica), Guduchi Extract (Tinospora cordifolia), Haridra Extract (Curcuma longa), Ashwaga
Sponsors
RV Newvisions Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. History of stage 0-II cancer with primary curative resection of the tumour (R0) within last 1 year, 2. Male and female patients are required to be > 18 years and 3. No evidence of recurrent disease since completion of initial treatment confirmed within last 1 year prior to randomization, 4. Patient with preoperative Neo-Adjuvant Chemo Therapy (NACT) or radiation therapy, 5. Patient who has an ECOG (Eastern Co-operative Oncology Group) performance status of 0-1, 6. Patient with i. Adequate bone marrow function (Leucocytes > 4,000 per mm3, Platelets > 100,000 per mm3), ii. Adequate liver function (Bilirubin iii. Adequate renal function (Creatinine 7. Patient with PET/CT scan showing no evidence of recurrence, 8. Patient with USG (whole abdomen, pelvis and chest) of showing no evidence of tumour, 9. Patient able to swallow oral medications, 10. Patient of low risk or moderate risk of cardiovascular events, 11. Patient who was not participated in any other clinical trial within last one month and who will not participated in any other clinical trial during the study period, 12. Patient who is fully informed of the both investigational products, 13. Patient willing to give his/her written informed consent for study participation and come for follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Patient who has serious or uncontrolled concurrent medical illness, and other active malignancy, 2. Patient who has advised post-operative radiation therapy or chemotherapy, 3. Patient having history of organ transplant, 4. Patient who has history of immunosuppressive therapy in last 1 month period form screening visit, 5. Patient who has been taking opoid analgesics except tramadol for pain management, 6. Patient is having pregnancy (in case of female patient), 7. Women/men of reproductive potential must agree to use effective contraception till the end of study, 8. History of colon resection > 40 cm, 9. High cardiovascular risk, uncontrolled hypertension and diabetes mellitus 10. Documented history of gastric/duodenal ulcer within last 12 months and/or current treatment or active symptoms of gastric/duodenal ulcer 11. Patient having dependency for any drug 12. Significant medical or psychiatric condition that would preclude study completion, 13. Basal cell or squamous cell skin cancer, 14. Patient operated for Glioma, 15. History of HIV infection 16. Subject undergoing renal dialysis, 17. Uncontrolled ascites (defined as not easily controlled with diuretic treatment), 18. Encephalopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease (recurrence) Free Survival for Three YearsTimepoint: Day 0, 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month, 24 month, 27 month, 30 month, 33 month, 36 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of specific tumor biomarker level 2.Assessment of cancer recurrence by PET/CT scans. 3.Assessment by USG 4.Chest X-ray 5.Assessment of ECOG performance scale 6.Assessment of Quality of Life Assessment 7.Assessment of clinical signs and symptoms. 8.Assessment of laboratory investigations 9.Assessment of drug compliance 10.Assessment of tolerability of study drugs 11.Assessment of clinical global evaluation for overall improvement by physician and by the patientTimepoint: Day 0, 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month, 24 month, 27 month, 30 month, 33 month, 36 month | — |
Countries
India
Contacts
Public ContactDr Vidyadhar Govind Vaidya
Lokmanya Medical Research Center
Outcome results
None listed