FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/11/059465 [Registered on: 02/11/2023] Trial Registered Prospectively
Last Modified On: 08/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Process of Care Changes
Behavioral
Nutraceutical
Other (Specify) [Quality of Life]  
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   12 Weeks Intervention of Body Revival in Breast Cancer Patients 
Scientific Title of Study   12-week Intervention of Body Revival (Ayurvedie Medicine) to Improve Quality of Life (QoL) and Progression Free Survival (PFS) to Counter Adverse Events of Chemotherapy or Radiotherapy in Post Surgery Breast Cancer Patients: A Randomized Case Control Study 
Trial Acronym  BC 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srikanta Pandit 
Designation  Associate Professor  
Affiliation  J B Roy State Ayurvedic Medical College and Hospital  
Address  Research Unit, 2nd Floor, Department of Kayachikitsha, J B Roy State Ayurvedic Medical College and Hospital 170 to 172 Raja Dinendra Street Kolkata

Kolkata
WEST BENGAL
700004
India 
Phone  9831723650  
Fax    
Email  srikantapandit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tuhin Kanti Biswas 
Designation  Professor 
Affiliation  J B Roy State Ayurvedic Medical College and Hospital Kolkata 
Address  Research Unit, 2nd Floor, Department of Kayachikitsha, J B Roy State Ayurvedic Medical College and Hospital 170 to 172 Raja Dinendra Street Kolkata

Kolkata
WEST BENGAL
700004
India 
Phone  9748664647  
Fax    
Email  biswastuhin@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Utpalendu Jana 
Designation  Professor 
Affiliation  J B Roy State Ayurvedic Medical College and Hospital Kolkata 
Address  Research Unit, 2nd Floor, Department of Kayachikitsha, J B Roy State Ayurvedic Medical College and Hospital 170 to 172 Raja Dinendra Street Kolkata

Kolkata
WEST BENGAL
700004
India 
Phone  9433180053  
Fax    
Email  janauin@gmail.com  
 
Source of Monetary or Material Support  
Health Reactive Excellency Bldg, 1st Floor, Opp. MTNL 4 Bunglow, MHADA Layout, Andheri (W), Mumbai-400053  
 
Primary Sponsor  
Name  Health Reactive 
Address  Excellency Bldg, 1st Floor, Opp. MTNL 4 Bunglow, MHADA Layout, Andheri (W), Mumbai-400053  
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 Srikanta Pandit  JB Roy State Ayurvedic Medical College and Hospital, Kolkata   Research Unit, 2nd Floor, Department of Kayachikitsha, 170 to 172 Raja Dinendra Street Kolkata 700004
Kolkata
WEST BENGAL 
9831723650

panditsrikanta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, J.B.Roy State Ayurvedic Medical College and Hospital, Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:C509||Malignant neoplasm of breast of unspecified site. Ayurveda Condition: GRANTHIH, (2) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: ARBUDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Body Revival, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 6(ml), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: Body Revival suspension, per oral, 6 ml (one teaspoon) in every 6th alternative day before going to bed (preferably in night)
2Comparator ArmLifestyle--Dinacarya: Not applicable, Ritucarya: not applicable, Acara Rasayana:not applicable, Other:without intervention, only supportive treatment (if required), Duration 12 weeks, regular follow up (baseline, 4 wk, 8 wk and 12 wk) and check up all parameters similar to intervention arm , Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  18 years of age or older; With a histologically or cytologically confirmed diagnosis of breast cancer (stage II–IV); Have been treated with surgery / first line chemotherapy / radiotherapy of not more than six months

Not relapsed during recruitment

Subjects may not have received Body Revival® or any herbal medicine
 
 
ExclusionCriteria 
Details  Clinically significant CNS, hepatic, cardio-respiratory or immunogenic problems;Pregnant woman and lactating mother; Subjects have received Body Revival® or any herbal medicine

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
(a) Progression free survival by blood CA-15.3, (b) Quality o Life by Questionnaire for cancer patients and (c) Karnofsky Performances (clinical assessments) are the primary outcomes by comparison between Intervention vs. case matched control (without intervention)   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
(a) Progression free survival by blood CA-15.3, (b) Quality o Life by Questionnaire for cancer patients & (c) Karnofsky Performances (clinical assessments) are the primary outcomes by comparison between Intervention vs. case matched control (without intervention)   12 weeks 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   03/11/2023 
Date of Study Completion (India) 30/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Approximately 48 subjects at JB Roy State Ayurvedic Medical College and Hospital with radiotherapy and chemotherapy treated post-operative breast cancer of greater than 1 and no more than 6 months from their surgery and chemotherapy/radiotherapy were randomized. Allocation was stratified by 1:1 treatment vs. case control of selected four arms. Control groups were not receive Body Revival but were allowed their regular conventional therapy, if any. Control groups were eligible to attend scheduled follow-ups. The results demonstrated that Body revival treatment significantly improved the quality of life for breast cancer patients in terms of general well being, physical well being, and psychological well being. It enhanced physical performance in everyday life. Test medicine also minimized the adverse consequences of chemotherapy and radiotherapy in cancer patients. It improved appetite, physical stamina and endurance while reducing nausea, constipation, muscle weakness, dizziness and exhaustion. Thus it may be conclude that Body Revival can aid with cancer therapy and management by reducing the negative effects of chemotherapy and radiotherapy on cancer patients. 

 
Close