FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/081408 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 14/03/2026
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  
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 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:C50||Malignant neoplasm of breast. Ayurveda Condition: TRUSHNA-UPADRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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: -
2Comparator 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   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.


 
Close