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CTRI Number  CTRI/2024/08/073040 [Registered on: 28/08/2024] Trial Registered Prospectively
Last Modified On: 05/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Exploring the Benefits of Meditation for Chronic Kidney Disease A Preliminary Study 
Scientific Title of Study   The Effect of Meditation as an Adjuvant Therapy in Chronic Kidney Disease CKD A Pilot Study 
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 and In-charge HoD of Integrative Medicine Department 
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 and In-charge HoD of Integrative Medicine Department 
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 and In-charge HoD of Integrative Medicine Department 
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 Tamaka Kolar 
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 
Shriya S  RL Jalappa Hospital and Research Center  Department of Nephrology RL Jalappa Hospital and Research Center Tamaka 563103
Kolar
KARNATAKA 		 8277624069

shriya.svk0@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  Meditation + Standard care  The intervention in this study is a mantra-based meditation along with standard care. Each session will roughly be 15 minutes twice a day. The experimental group will be exposed to this intervention 5 days a week for 1 month under the supervision of a trained Yoga Therapist.  
Comparator Agent  Standard care  Patients will undergo standard care under the supervision of a nephrologist. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with CKD and undergoing dialysis
2. Those who have given informed consent for completing the study
3. Those who are mentally and physically fit up to a minimum level to understand and perform the practices will be included.
 
 
ExclusionCriteria 
Details  1. Participants with a history of substance abuse, psychotic illnesses, and those on therapy for psychotic illness.
2. Other chronic conditions, such as recent stroke and post-coronary artery bypass grafting.
3. Recent abdominal surgeries.
4. Solid organ or bone marrow transplant.
5. Active malignancy in the last 2 years.
6. Palpitations or dyspnoea at rest or asymptomatic only when resting.
7. Pregnant women.
8. Those who are currently on immunosuppressive drug therapy.
9. Those with an expected life expectancy of less than 1 year.
10. Those with vocal cords or speech problems.
11. Those with exposure to yoga and meditation in the past 3 months. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Heart Rate Variability
Health-Related Quality of Life 		 Data collection will be done first at baseline on the 0th day. Intervention will be given from day 1 to day 30. Post-data collection will be done on the 31st day. 
 
Secondary Outcome  
Outcome  TimePoints 
Perceived stress levels
Level of mindfulness 		 Data collection will be done first at baseline on the 0th day. Intervention will be given from day 1 to day 30. Post-data collection will be done on the 31st day. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/09/2024 
Date of Study Completion (India) 16/02/2026 
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 progressive decline in renal function that affects a significant portion of the adult population. It is characterized by structural and functional abnormalities within the kidneys, often remaining asymptomatic during the initial stages but predisposing individuals to various complications, including cardiovascular ailments, end-stage renal failure, anemia, metabolic bone disorders, and neurological manifestations. CKD is typically defined by renal impairment or a glomerular filtration rate (GFR) below 60 mL/min/1.73 m^2, with albuminuria as an additional diagnostic criterion. CKD is associated with coronary artery disease, making managing it complex due to its multifaceted nature and concurrent comorbidities. CKD precipitates premature aging through mechanisms involving increased allostatic load, dysregulated stress response, facilitation of aging processes, and inhibition of anti-aging pathways. CKD patients experience a range of symptoms, including disturbances in sleep patterns, somnolence, fatigue, pruritus, anorexia, muscle cramping, and skeletal pain. Frailty is an independent correlate of heightened symptomatology and compromised health-related quality of life in CKD patients. Depression and anxiety are notably elevated among CKD patients, primarily due to the adverse health outcomes and diminished quality of life associated with the condition. Mind-body therapies, such as meditation, have been investigated for their potential role in CKD patients. Evidence suggests that mindfulness meditation can effectively mitigate chronic pain and mood disturbances, enhancing their overall quality of life. However, further research is needed to explore the potential benefits of meditation and its incorporation into standard treatment regimens for CKD patients undergoing dialysis.

Research on meditation’s impact on chronic kidney disease (CKD) patients has mainly focused on short-term outcomes, highlighting the need for longitudinal studies to evaluate its sustained effects on clinical parameters like dialysis efficacy, renal function, and overall health. The dose-response relationship between meditation practice and therapeutic benefits for CKD patients is unclear, necessitating further investigation to identify the optimal frequency, duration, and type of meditation practice. Evidence suggests meditation can improve emotional resilience and reduce stress in CKD patients, but the exact mechanisms are poorly understood. There is also a need to understand how meditation can be integrated into multidisciplinary healthcare settings, considering feasibility, scalability, and healthcare provider training. This study aims to examine the impact of meditation as an adjunctive therapeutic modality for improving CKD patients’ overall well-being, with potential for integration within the standard care regimen.
 
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