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CTRI Number  CTRI/2014/02/004371 [Registered on: 03/02/2014] Trial Registered Retrospectively
Last Modified On: 18/01/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical trial of RV CAPS in Comparison with Grape Seed Capsule in Preventing Recurrence of Cancer. 
Scientific Title of Study   A Randomized, Open Labeled, Single Center, Parallel Group, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of ‘RV CAPS’ in Comparison with Grape Seed Capsule in Preventing Recurrence of Cancer in Patients Who Have Undergone Surgery for Cancer 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RVNVHPL/AY/01/2013, Version: V0, Date: 01.03.2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidyadhar Govind Vaidya 
Designation  Director and Managing Trustee  
Affiliation  Lokmanya Medical Research Center 
Address  314/B Telco Road Chinchwad Pune

Pune
MAHARASHTRA
411033
India 
Phone  9822057766  
Fax    
Email  vgvaidya@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vidyadhar Govind Vaidya 
Designation  Director and Managing Trustee  
Affiliation  Lokmanya Medical Research Center 
Address  314/B Telco Road Chinchwad Pune


MAHARASHTRA
411033
India 
Phone  9822057766  
Fax    
Email  vgvaidya@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vidyadhar Govind Vaidya 
Designation  Director and Managing Trustee  
Affiliation  Lokmanya Medical Research Center 
Address  314/B Telco Road Chinchwad Pune


MAHARASHTRA
411033
India 
Phone  9822057766  
Fax    
Email  vgvaidya@hotmail.com  
 
Source of Monetary or Material Support  
RV Newvisions Healthcare Pvt Ltd Deccan Pride 2nd Floor Above Indian Overseas Bank Deccan Gymkhana Pune-04 
 
Primary Sponsor  
Name  RV Newvisions Healthcare Pvt Ltd 
Address  Deccan Pride 2nd Floor Above Indian Overseas Bank Deccan Gymkhana Pune 04 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vidyadhar Govind Vaidya  Department of Oncology  Ground Floor, Lokmanya Medical Research Center and Lokmanya Hospital 314/B Telco Road Chinchwad Pune
Pune
MAHARASHTRA 		 9822057766

vgvaidya@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Lokmanya Medical Research Centre, Chinchwad, Pune.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Prevention of cancer following surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Grape Seed Capsule  Each capsule Contains: Draksha Extract (Vitis vinifera) Dose and Treatment Duration: Two capsules twice daily orally after meals for 3 years  
Intervention  RV CAPS  Each capsule Contains: Draksha Extract (Vitis vinifera), Amalaki Extract (Phyllanthus emblica), Guduchi Extract (Tinospora cordifolia), Haridra Extract (Curcuma longa), Ashwagandha Extract (Withania somnifera), Pippali Extract (Piper longum) Dose and Treatment Duration: Two capsules twice daily orally after meals for 3 years 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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 <70 years of age,
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 < 1.5 mg/dl),
iii. Adequate renal function (Creatinine < 1.5 mg/dl),
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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Disease (recurrence) Free Survival for Three Years  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 Outcome  
Outcome  TimePoints 
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 patient  		 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  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/01/2014 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This study is an open label, randomized, comparative, parallel group, single center, prospective, interventional, clinical study to evaluate efficacy and safety of ‘RV CAPS’ in comparison with ‘Grape Seed Capsule’ in preventing recurrence of cancer in patients who have undergone surgery for cancer. The study will be conducted in 120 subjects of having history of stage 0-II cancer with primary curative resection of the tumour (R0) and with no evidence of recurrence within last 1 year. The study will be conducted at Lokmanya Medical Research Centre and Lokmanya Hospital, Chinchwad Pune. The primary outcome will be to evaluate the efficacy of ‘RV CAPS’ in comparison with ‘Grape Seed Capsule’ by assessing the disease (recurrence) free survival of subject for three years. Subjects will be called at study site for 3 monthly follow-up including Screening visit (day -7), and baseline visit (Day 0) i.e. 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month, Visit 24 month, 27 month, 30 month, 33 month and 36 month.The secondary objectives will be to evaluate the efficacy and safety of RV CAPS in comparison with Grape Seed capsule in prevention of recurrence of cancer by assessing specific tumor biomarker level (3 monthly), PET/CT scans (12 monthly), USG (whole abdomen, pelvis and chest) (on 6 month, 18 month, 30 month), Chest X-ray (PA-View) (6 monthly), Eastern Co-operative Oncology Group (ECOG) performance scale (on every follow up visit), clinical signs and symptoms (3 monthly),WHOQOL (3 monthly) and laboratory investigations viz. CBC, Hb%, ESR, LFTs, RFTs, Lipid Profile, Urine R & M, and Blood Sugar Level-Fasting (on screening visit and at the end of the study). Also, drug compliance (on every follow-up visit), treatment acceptability/tolerability by patient and physician, and clinical global evaluation for overall improvement by physician and by the patient himself/herself will be assessed as secondary outcomes [on Day 0 and Visit 12 (36 months)].

 
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