| CTRI Number |
CTRI/2025/02/081408 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical
Other (Specify) [Therapeutic diet] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Trushna Shamak Yavagu in Breast cancer patients to reduce the side effects of Chemotherapy |
|
Scientific Title of Study
|
An open labeled randomised controlled clinical study to assess the efficacy of Trushna Shamak Yavagu in the alleviation of chemotherapy induced side effects in Breast cancer patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nisha Sane |
| Designation |
PG student |
| Affiliation |
D.Y.Patil School of Ayurveda |
| Address |
Oncology OPD, D. Y. Patil Hospital and D.Y.Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai,Maharashtra 400706.
D.Y.Patil deemed to be University School of Ayurveda. Sector 7,Nerul, Navi Mumbai,Maharashtra 400706.
Thane
MAHARASHTRA
400706
India |
| Phone |
9004548001 |
| Fax |
|
| Email |
drnishasane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Pawar |
| Designation |
Associate Professor and Guide |
| Affiliation |
D.Y.Patil School of Ayurveda |
| Address |
D.Y.Patil School of Ayurveda. Sector 7,Nerul, Navi Mumbai,Maharashtra 400706.
Thane
MAHARASHTRA
400706
India |
| Phone |
7506631982 |
| Fax |
|
| Email |
vinay.pawar@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay Pawar |
| Designation |
Associate Professor and Guide |
| Affiliation |
D.Y.Patil School of Ayurveda |
| Address |
D.Y.Patil School of Ayurveda. Sector 7,Nerul, Navi Mumbai,Maharashtra 400706.
Thane
MAHARASHTRA
400706
India |
| Phone |
7506631982 |
| Fax |
|
| Email |
vinay.pawar@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| D.Y.Patil Hospital, sector 7, Nerul,Navi Mumbai, Maharashtra. 400706 |
|
|
Primary Sponsor
|
| Name |
Dr.Nisha Sane |
| Address |
D.Y.Patil College of Ayurved Hospital Research Institute.sector 7,Nerul,Navi Mumbai,Maharashtra.400706 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrNisha Sane |
D.Y.Patil Hospital, sector 7,Nerul,Navi Mumbai,Maharashtra.400706 |
Oncology OPD, D. Y. Patil Hospital, sector 7,Nerul,Navi Mumbai,Maharashtra.400706
Thane
MAHARASHTRA |
9004548001
drnishasane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC D.Y.Patil deemed to be university.Navi Mumbai. |
Approved |
| IEC D.Y.Patil Hospital Navi Mumbai. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C50||Malignant neoplasm of breast. Ayurveda Condition: TRUSHNA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trushna Shamak Yavagu, Reference: Ca.Su.2/24, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 80(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 63 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | | Chemotherapy induced side effects in Breast cancer patients. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Diagnosed carcinoma (breast) patients on chemotherapy
2.Age 18 to 60 years of females
3.Patients with mild to moderate side effects
4.Controlled Diabetes Mellitus & Hypertension
|
|
| ExclusionCriteria |
| Details |
1.Cycle 01 of Chemotherapy
2.With severe cases of side effects
3.Uncontrolled Diabetes Mellitus & Hypertension, Pregnant and Lactating women, With contagious diseases such as TB or Hepatitis C
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement on MSAS scale |
every 7 days for 63 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any effect on Quality of life |
every 30 days till 63 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "47"
Final Enrollment numbers achieved (India)="47" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/03/2025 |
| Date of Study Completion (India) |
16/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/01/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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)
|
This study is randomised , open labeled ,parallel group, single centre trail assessing the efficacy of Trushna Shamak Yavagu 80 ml twice a day for 63 days to alleviate the side effects of chemotherapy in breast cancer female patients.The primary outcome measure will be alleviation of chemotherapy induced side effects in these patients. The secondary out come will be the improvement of quality of life in them. The assessment of MSAS scale will be done every after 7 days for completion of 3 chemo cycles. After the enrolment of the patient the posology will be followed. The consent form will be taken prior to the trial on the second chemo day and the drug will be dispensed for next 21 days (42 sachets of TSY with 5 extra sachets of TSY. The extra TSY is given in case of any spillage. The TSY sachets will be named and numbered. The patients are asked to keep the empty sachets carefully to give it back at the time of next TSY dispensing to ensure the administration of complete drug. Scale will be checked and recorded on that day. 1st follow up will be after 7 days, which is the 8th day of 2nd chemotherapy cycle. The scale will be checked to assess the immediate side effects of chemotherapy. On the 15th day the 2nd follow up will be recorded to assess the delayed side effects of chemotherapy. 3rd follow up will be on the 3rd chemotherapy cycle which will be 21st day of 2nd chemo and 1st day of 3rdchemotherapy. The scale will be recorded. The first set of empty TSY sachets will be collected back and the 2nd pack of named and labelled TSY will be handed over to the patient. If any extras are used due to any spillage the extra sachets will be replaced. 4th follow up will be 8th day of 3rd chemotherapy cycle to record the immediate side effects of chemotherapy. 5th follow up will be recorded on the 15th day of 3rd chemotherapy cycle to assess the delayed side effects of chemotherapy. 6th follow up- 1st day of 4th chemotherapy and 21st day of 3rd chemotherapy cycle. Scale will be recorded. The second set of empty TSY sachets will be collected back and the 3rd pack of named and labelled TSY will be handed over to the patient. If any extra used due to any spillage the extra sachet will be replaced. 7th follow up will be on 8th day of 4th chemotherapy cycle to record the immediate side effects of chemotherapy. 8th follow up will be on the 15th day of 4th chemotherapy cycle to record the delayed side effects of chemotherapy. 9th follow up will be 21st day of 4th chemotherapy cycle. The records of every follow-up will be studied together, and results will be drawn. There will be comparison between immediate side effects(8th day) and delayed side effects(15th day) with 21st day every chemotherapy cycle. Also there will be comparison between every cycle of chemotherapy in individuals. There will be comparison-base devaluation in Control-Group and Trial-Group to get the final results. Study completed Total no. of patients enrolled - 47 Trial Group - completed 30, dropouts 02 due to lost to follow up Control Group - completed 15, no dropouts No SAEs observed during or after completion of trial.
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