| CTRI Number |
CTRI/2025/08/092981 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Yoga on Kidney Disease |
|
Scientific Title of Study
|
Effect of Yoga intervention on progression of 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 Rima Dada |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 1036, Teaching block, First Floor, Department of Anatomy, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9811783318 |
| Fax |
|
| Email |
rimadadaaiims20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Supriya Verma |
| Designation |
PhD Scholar |
| Affiliation |
AIIMS, New Delhi |
| Address |
Lab No. 1027, Teaching block, First Floor, Department of Anatomy, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8679501141 |
| Fax |
|
| Email |
supriyaverma@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rima Dada |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 1036, Teaching block, First Floor, Department of Anatomy, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9811783318 |
| Fax |
|
| Email |
rimadadaaiims20@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, India,110029 |
|
|
Primary Sponsor
|
| Name |
Dr Rima Dada |
| Address |
Room No. 1036, teaching block, First Floor, Department of Anatomy, AIIMS, New Delhi, India, 110029 |
| Type of Sponsor |
Other [Chief Guide] |
|
|
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 |
| Dr Rima Dada |
All India Institute of Medical Sciences, New Delhi |
Lab. 1027, Teaching Block, First floor, Department of Anatomy, AIIMS, New Delhi, 110029
South
DELHI |
9811783318
rimadadaaiims20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee,AIIMS, New delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (2) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
none |
not applicable |
| Intervention |
yoga |
12 week yoga intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
CKD stage 3 & 4 patients,
Mentally and physically fit up to a level to understand and perform yogic asanas,
Not enrolled in regular yoga practice
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria will be HIV, HCV HBsAg +ve patients, individuals with severe cardiovascular conditions active infection, respiratory conditions COPD, neurological disorder and cancer. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
25% reduction in Proteinuria
|
After 3 months of yoga intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stable eGFR (estimated glomerular filtration rate) or increase in eGFR |
After 3 months of yoga intervention |
| Reduction in markers of inflammation and oxidative stress post yoga |
After 3 months of yoga intervention
|
| Markers of CKD metabolic bone disease and kidney injury will toward normal |
After 3 months of yoga intervention |
| Reduction in adipokine levels in blood |
After 3 months of yoga intervention |
| Expression and methylation pattern of genes involved in CKD will come toward normal |
After 3 months of yoga intervention |
| Profibrotic miRNA in urinary exosomes should decrease |
After 3 months of yoga intervention |
| Improvement in quality of life |
After 3 months of yoga intervention |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 global health burden defined as irreversible kidney injury and has repercussions for other organs, leading to many extrarenal complications. Currently, CKD treatment focuses on its complications, hypertension, diabetes. Underlying mechanism driving CKD like oxidative stress, inflammation remain unaddressed. Yoga targets these factors and control blood pressure, diabetes which is crucial to slowdown CKD progression. Yoga modulates gene expression epigenetically, improves fitness, mental health thereby improving QOL. Effects of lifestyle intervention like yoga which target physical, psychological & molecular aspects of body remain explored in CKD. Our study aims to find effect of yoga on CKD progression by assessing clinical, molecular parameters, urinary exosomal miRNA. |