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CTRI Number  CTRI/2025/12/098469 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 01/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Yoga Practices on Quality of Life, Mental Health, Treatment-related Symptoms, and Ayurvedic Classification of Prakruti, Vikruti in Breast Cancer Patients Undergoing Radiotherapy 
Scientific Title of Study   Effect of Integrative Yoga Program on Quality of Life, Mental Health, Prakriti, and Treatment-related Symptoms in Breast Cancer Patients Undergoing Radiotherapy  
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 Sunita Chaudhari  
Designation  PhD Scholar  
Affiliation  Dr.Vishwanath Karad MIT World Peace University  
Address  Dr.Vishwanath Karad MIT World Peace University, Department of Consciousness Studies, Room No 1, Survey No, 124, Paud Rd, Kothrud, Pune, Maharashtra 411038
Dr.Vishwanath Karad MIT World Peace University, Department of Consciousness Studies, Room No 1, Survey No, 124, Paud Rd, Kothrud, Pune, Maharashtra 411038
Pune
MAHARASHTRA
411038
India 
Phone  09850060068  
Fax    
Email  sunitachaudhari3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof.Dr. Sanjeev Kumar  
Designation  Professor  
Affiliation  Dr.Vishwanath Karad MIT World Peace University  
Address  Dr.Vishwanath Karad MIT World Peace University, Department of Consciousness Studies, Room No 1, Survey No, 124, Paud Rd, Kothrud, Pune, Maharashtra 411038
Dr.Vishwanath Karad MIT World Peace University, Department of Consciousness Studies, Room No 1, Survey No, 124, Paud Rd, Kothrud, Pune, Maharashtra 411038
Pune
MAHARASHTRA
411038
India 
Phone  09850060068  
Fax    
Email  sanjeev.kumar@mitwpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sunita Chaudhari  
Designation  PhD Scholar  
Affiliation  Dr.Vishwanath Karad MIT World Peace University  
Address  Dr.Vishwanath Karad MIT World Peace University, Department of Consciousness Studies, Room No1, Survey No, 124, Paud Rd, Kothrud, Pune, Maharashtra 411038
Dr.Vishwanath Karad MIT World Peace University, Deparment of Consciousness Studies, Room No. 1, Survey No, 124, Paud Rd, Kothrud, Pune, Maharashtra 411038
Pune
MAHARASHTRA
411038
India 
Phone  09850060068  
Fax    
Email  sunitachaudhari3@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Sunita Chaudhari  
Address  Dr.Vishwanath Karad MIT World Peace University, Survey No, 124, Paud Rd, Kothrud, Pune, Maharashtra 411038  
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
MsSunita Chaudhari  Jupiter Lifeline Hospital, Baner  Radiation Department, Lower Basement, Room No 1,Near PrathameshParkBaner Pune 411045
Pune
MAHARASHTRA 		 9850060068

sunitachaudhari3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JupiterLifelineHospitalEthicsCommittee  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, (2) ICD-10 Condition: D||Radiation Therapy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventaionl Radiation Schedule  Conventional Radiation Schedule adviced by radiation oncologist  
Intervention  Conventional Radiation Therapy +Integrative Yoga   Radiation Schedule + Integrative yoga. Duration 12 weeks, Length of session 30-45 minutes and practices - Prakruti related Life-style + Loosening exercise, Asana, Pranayama, Relaxation, Meditation, Chanting, affirmatin prayer.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Subjects with a confirmed diagnosis of Breast cancer patients, stage I to III, scheduled to undergo radiotherapy, ECOG-PS: 0 to 2 or KPS score more than 70, who are willing to give consent and participate in the 12-week intervention study protocol for hybrid-online and offline mode 
 
ExclusionCriteria 
Details  Subjects with Stage IV breast cancer with Metastasis, Patient planned for Brachytherapy, Neo-adjuvant Chemo with radiotherapy, currently doing another form of structured yoga, Severe medical co-morbidities, inability to perform yoga, Pregnant women, those who are on medication for severe psychotic diseases, Severe immobility due to arthritis, vision, and hearing impairment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
EORTC 42 (Quality of life),
HADS (Anxiety and Depression Score),
PSS (Perceived Stress score),
PSQI (Pittsburgh Sleep Quality score),
treatment-related symptoms(VAS Score),
Prakruti -vikruti questionnaire,
Nadipariksha score
 		 Timepoints:
T1=Baseline (prior to start of radiation therapy)
T2= End of radiation therapy (approx. 6 weeks from baseline)
T3= 12 weeks from baseline
EORTC 42:T1.T2,T3,
HADS:T1.T2,T3,
PSS:T1,T2,T3,
PSQI:T1T2T3,
symptoms(VAS Score): T1,T2,T3,
Prakruti -vikruti Priksha: T1,T2
Nadipariksha: daily between T1 and T2
 
 
Secondary Outcome  
Outcome  TimePoints 
Hear Rate Variability (HRV )  T1,T2 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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   N/A 
Date of First Enrollment (India)   14/12/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sunitachaudhari3@gmail.com].

  6. For how long will this data be available start date provided 01-08-2029 and end date provided 31-12-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study will evaluate whether yoga can improve quality of life, mental health, sleep, and fatigue in women with non-metastatic breast cancer receiving radiotherapy. About 128 participants aged 18–65 years will be randomly assigned to two groups. One group will continue standard cancer treatment along with a guided yoga program (45 minutes, five times a week for 12 weeks), while the other group will receive only standard treatment. The study will also explore whether Ayurvedic body type (Prakriti) influences the benefits of yoga. 
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