| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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) | | 2 | Comparator Arm | Lifestyle | - | - | 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. |