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CTRI Number  CTRI/2024/08/072835 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 05/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Single Arm Study 
Public Title of Study   Developing a standard yoga module for kidney failure patients on dialysis 
Scientific Title of Study   Development Validation and Pilot Testing of a standard Yoga Module for Chronic Kidney Disease 
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 Ashween Bilagi 
Designation  Assistant Professor 
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Department of Integrative Medicine Sri Devaraj Urs Academy of Higher Education and Research Tamaka Kolar

Kolar
KARNATAKA
563103
India 
Phone  9886666636  
Fax    
Email  ayushashwin@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashween Bilagi 
Designation  Assistant Professor 
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Department of Integrative Medicine Sri Devaraj Urs Academy of Higher Education and Research Tamaka Kolar

Kolar
KARNATAKA
563103
India 
Phone  9886666636  
Fax    
Email  ayushashwin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashween Bilagi 
Designation  Assistant Professor 
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Department of Integrative Medicine Sri Devaraj Urs Academy of Higher Education and Research Tamaka Kolar

Kolar
KARNATAKA
563103
India 
Phone  9886666636  
Fax    
Email  ayushashwin@gmail.com  
 
Source of Monetary or Material Support  
Sri Devaraj Urs Academy of Higher Education and Research Tamaka, Kolar- 563103 Karnataka, India 
 
Primary Sponsor  
Name  Dr Ashween Bilagi 
Address  Department of Integrative Medicine Sri Devaraj Urs Academy of Higher Education and Research 
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 
Dr Shobhana Nayak Rao  RL Jalappa Hospital and Research Center  Room no. 531 Department of Nephrology Tamaka Kolar
Kolar
KARNATAKA 
9945982509

shobhana.nayak.rao@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrated Yoga + Standard care  A validated structured yoga module will be given to the intervention group; each session will last for 1 hour. The intervention will be given 3 times a week for 4 weeks 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Individuals diagnosed with CKD and undergoing dialysis.
2. Those who provide informed consent. 
 
ExclusionCriteria 
Details  1. Individuals with a history of substance abuse, psychotic illnesses and those on therapy for psychotic illness.
2. Other chronic conditions: Recent stroke, Post coronary artery bypass grafting (CABG), morbid obesity, uncontrolled diabetes and hypertension.
3. Recent fractures of the lower limb/ recent lower limb surgery, severe knee joint pain or osteoarthritis will be excluded from the study.
4. Exposure to yoga in the past 3 months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Perceived stress levels
Quality of sleep 
Data collection will be done initially at baseline. The intervention will be given for 4 weeks. Post-data will be collected after 4th week. 
 
Secondary Outcome  
Outcome  TimePoints 
Experience and acceptance of yoga.
Other biochemical parameters. 
Data collection will be done initially at baseline. The intervention will be given for 4 weeks. Post-data will be collected after 4th week. 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/09/2024 
Date of Study Completion (India) 30/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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  

Chronic Kidney Disease (CKD) is a prevalent and debilitating condition affecting millions worldwide. As the prevalence of CKD increases, there is a growing need for complementary therapies to complement traditional medical interventions. Yoga has been recognized as a holistic approach to enhancing physical, mental, and emotional well-being. Studies have shown that yoga interventions can improve various parameters related to CKD, such as blood pressure, oxidative stress, inflammation, and psychological stress. Yoga practices can also improve health-related quality of life, sleep disturbances, and fatigue in cancer patients. Additionally, yoga practices can reduce inflammatory markers and improve kidney function, lipid profiles, and overall quality of life in CKD patients. This research proposal aims to develop and validate a specialized yoga module specifically for CKD patients, ensuring consistency in the delivery of yoga interventions across different healthcare settings and research studies. The safety and feasibility of yoga practices for CKD patients is a critical gap in current knowledge. There is a lack of standardized yoga protocols tailored specifically for CKD patients, which hinders the evidence-based implementation of yoga as a therapeutic intervention. A patient-centred approach is needed in the development and validation of yoga protocols. The current literature focuses on short-term outcome of a sustained yoga practice on disease progression and quality of life. 


 
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