| CTRI Number |
CTRI/2024/10/076040 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the effect of nutritional diet containing figs, dates and black raisins in improving anemia caused in breast cancer patients due to chemotherapy |
|
Scientific Title of Study
|
Nutritional intervention of raisins, dates, and figs for chemotherapy-induced anemia (Pandu) in breast cancer patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Bhagwan Chavan |
| Designation |
Research Officer |
| Affiliation |
Bharatiya Sanskriti Darshan Trusts Integrated Cancer Treatment and Research Centre |
| Address |
Centre of Excellence Buidling 2nd Floor Gat No 676 Kesnand Road Wagholi Pune 412207 Maharashtra India
Pune
MAHARASHTRA
412207
India |
| Phone |
9975611176 |
| Fax |
|
| Email |
ictrcdrugresearch2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineeta Deshmukh |
| Designation |
Deputy Director |
| Affiliation |
Bharatiya Sanskriti Darshan Trusts Integrated Cancer Treatment and Research Centre |
| Address |
Panchkarma Buidling, Ground Foor, Deputy Director Cabin Gat No 676 Kesnand Road Wagholi Pune 412207 Maharashtra India
Pune
MAHARASHTRA
412207
India |
| Phone |
02067346000 |
| Fax |
|
| Email |
ictrcpune@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geeta Dharmati |
| Designation |
PhD Guide |
| Affiliation |
Tilak Maharashtra Vidyapeeth |
| Address |
Department of Ayurveda (PG Nanal), 1st Floor, TMV Campus, Gultekdi, Pune
Pune
MAHARASHTRA
411037
India |
| Phone |
9527552221 |
| Fax |
|
| Email |
geetaud@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharatiya Sanskriti Darshan Trusts Integrated Cancer Treatment and Research Centre, Centre of Excellence Building, Ground Floor, Office Cabin, Wagholi Pune 412207 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Bharatiya Sanskriti Darshan Trusts Integrated Cancer Treatment and Research Centre Wagholi Pune |
| Address |
Gat No 676, Kesnand Road, Wagholi, Pune- 412207, Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Ayurveda Tilak Maharashtra Vidyapeeth |
Gultekdi, Pune- 411 037, Maharashtra, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Chavan |
Integrated Cancer Treatment and Research Centre |
Centre of Excellence Building, 1st Floor, Chemotherapy Ward, Gat No 676, Kesnand Road, Wagholi, Pune- 412207, Maharashtra, India
Pune
MAHARASHTRA |
9975611176
ictrcdrugresearch2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Bharatiya Sanskriti Darshan Trusts Integrated Cancer Treatment and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D538||Other specified nutritional anemias. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Control | Patient will undergo routine chemotherapy (8-12 cycles) as prescribed by the Oncologist and no Ayurvedic intervention will be given. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Anjeeradi Yog, Reference: NA, Route: Oral, Dosage Form: Modaka, Dose: 45(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: Anjeeradi Yog contains Dates 20 g Figs 20 g and Black raisins 5 g and will be an Ayurvedic intervention for the patient who will undergo routine chemotherapy (8-12 cycles) as prescribed by the Oncologist. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Female Breast Cancer patients up to Stage III, undergoing first-line chemotherapy with or without hormonal and radiotherapy treatment |
|
| ExclusionCriteria |
| Details |
Male breast cancer patients, Breast Cancer patients scheduled for second-line chemotherapy, Planned for neoadjuvant chemotherapy, Post- blood transfusion before starting the chemotherapy, Patients taking iron supplements
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemoglobin, Total WBC, Differential Leucocyte count, RBC Indices, Platelet indices, Erythrocyte Sedimentation rate; Iron specific: Serum iron, Serum ferritin, Transferrin level or Total Iron Binding Capacity; LFT: Sr. Bil., SGPT, SGOT, KFT: Sr. Creatinine, BUN and BSL (Random) |
A- 0 week as Baseline - before starting chemotherapy
B- 12 weeks as Mid-chemotherapy
C - 24 weeks at the end of chemotherapy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of Ayurvedic symptoms of Pandu viz., Panduta, Rukshata, Agnimandya, Aruchi, Shaithilya, Hrudrava
2. FACIT- Fatigue Scale
3. FACT-AN Scale
4. Quality of Life core module C-30 & BR-45 breast cancer questionnaires
5. Karnofsky’s Performance Score
6. Weight
|
A- 0 week as Baseline- before starting chemotherapy
B- 12 weeks as mid- chemotherapy
C - 24 weeks at the end of chemotherapy |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/11/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Data will be made available after reasonable request to the PI or corresponding author of the publication
- For how long will this data be available start date provided 01-08-2027 and end date provided 31-07-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
| This is a randomized, single blind, controlled clinical study, to assess the effects of nutritional intervention of black raisins, figs and dates in breast cancer female patients undergoing first line chemotherapy for a period of 6 months. The primary objective is to assess hematological; iron specific status as Serum iron, Serum ferritin, Transferrin level or Total Iron Binding Capacity; liver functions and Kidney functions. The secondary outcomes will include Ayurvedic symptom assessment, FACIT- Fatigue Scale, FACT-AN Scale, Quality of Life assessed by core module C-30 and BR-45 breast cancer questionnaires, Karnofsky’s Performance Score, and weight at all times points. Both groups will be taking chemotherapy and allied drugs such as Filgrastim (as and when required) during chemotherapy as prescribed by the oncologist. There will be no deviation from the standard line of treatment in both groups. Those patients exhibiting hemoglobin levels below 8 mg/dl will be advised to undergo blood transfusion as prescribed by the oncologist for continuation of chemotherapy. The intervention under this proposed study will be completed as per the study design and all significant events will be noted carefully for further assessment. | |