| CTRI Number |
CTRI/2025/05/087451 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of yoga on chronic kidney disease |
|
Scientific Title of Study
|
Yoga as a complementary therapy in Chronic Kidney Disease: Impact on clinical, biochemical, molecular and quality of life parameters in CKD stage 3 and 4 |
| 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
South
DELHI
110029
India |
| Phone |
9811783318 |
| Fax |
|
| Email |
rimadadaaiims20@gmail.com |
|
Details of Contact Person
Scientific 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
South
DELHI
110029
India |
| Phone |
9811783318 |
| Fax |
|
| Email |
rimadadaaiims20@gmail.com |
|
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
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 [Self] |
|
|
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, India, 110029 |
Lab. 1027, Teaching Block, First floor, Department of Anatomy, AIIMS, New Delhi, 110029
South
DELHI
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 |
NIL |
NIL |
| Intervention |
Yoga |
Yoga (12 week) intervention, 5 days a week, 70 minutes a day
1 Prayer - (2 min.)
2 Yogic sukhsma vyayam - (3 min.)
3 Yogic sthula vyayam (8 min)- Sarvang Pushti,
Hrid gati
Surya namaskar
4 Yoga Asanas:(25 min)
1. Standing - Tadasana, Tiryak tadasana and Kati chakrasana
2. Sitting- Malasana, Baddha Konasana, Yoga Mudrasana,
Chakki chalanasana, janu sirsasana, Ushtraasana,
Brahmacharyasana and Marjariasana
3. Lying down-
Prone - Bhujang asana, Dhanur asana and Nauka asana
Supine-Supta badha kanasana, Uttana padasana, Markatasana and Shavasana
5 Pranayam (25 min)- Kapalbhati, Bhastrika, Nadi shoadhna and Bhramri
Mudra- Vayu, Moolbandh, Vipreetkarni and Ashwini Mudra
6 Breath awareness with health affirmation and Chakra meditation - (5 min)
7 Prayer - (2 min)
|
|
|
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 |
| Reduction in proteinuria, stable or increased glomerular filtration rate, improvement in renal function tests and quality of life. |
After 3 months of yoga intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in markers of inflammation and oxidative stress.
Markers of CKD metabolic bone disease and kidney injury and adipokines will come toward normal. |
After 3 months of yoga intervention. |
Expression and methylation pattern of genes involved in CKD will come toward normal.
Profibrotic miRNA in urinary exosomes should decrease post yoga. |
After 3 months of yoga intervention. |
| Dysregulated lipids and metabolites in blood of CKD patients will be identified by advanced omics techniques. (LC-MS) |
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
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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. Objectives: 1. To determine effect of yoga intervention on CKD progression by assessing clinical parameters (eGFR, proteinuria, RFT’s, BCM) along with QOL in CKD patients. 2. To investigate effect of yoga on markers of inflammation, oxidative stress, CKD metabolic bone disease, kidney injury and adipokines 3. To investigate effect of yoga on expression and methylation pattern of genes involved in CKD and impact on miRNA profile in urinary exosomes 4. To investigate effect of yoga on dysregulated lipids and metabolites in blood by using advanced omics techniques (LC-MS) Methods: Blood samples for biochemistry, ELISA, PCR, LC-MS. Urine samples for proteinuria estimation and exosome isolation. Expected Outcome: Improvement in clinical parameters, biomarkers and normalization of dysregulated genes, miRNA expression along with enhanced QOL and identification of novel dysregulated lipids and metabolites. |