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CTRI Number  CTRI/2026/01/102094 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Strengthening Heart Health in Type-2 Diabetes: The Role of Yoga in Preventing Cardiovascular Disease 
Scientific Title of Study   Impact of Yoga on Atherosclerotic Cardiovascular Disease Risk Reduction in Type-2 Diabetes (Yoga-AtheroCaRRe):Exploring the Protective Effects and Molecular Mechanisms 
Trial Acronym  YogaAtheroCaRRe 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Guru Praveen S 
Designation  Junior Research Fellow 
Affiliation  SDM college of Medical Sciences and Hospital 
Address  #108, 25th cross, D Block, 1st Stage, J P Nagara, Mysore
SDM college of Medical Sciences and Hospital, Sattur
Dharwad
KARNATAKA
570031
India 
Phone  9740868362  
Fax    
Email  drgurupraveens@sdmuniversity.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Satish G Patil 
Designation  Professor 
Affiliation  SDM college of Medical Sciences and Hospital 
Address  SDM college of Medical Sciences and Hospital, Sattur, Dharwad.
SDM college of Medical Sciences and Hospital, Sattur
Dharwad
KARNATAKA
580009
India 
Phone  9986789583  
Fax    
Email  satish.patil@sdmuniversity.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Guru Praveen S 
Designation  Junior Research Fellow 
Affiliation  SDM college of Medical Sciences and Hospital 
Address  #108, 25th cross, D Block, 1st Stage, J P Nagara, Mysore
SDM college of Medical Sciences and Hospital, Sattur
Dharwad
KARNATAKA
570031
India 
Phone  9740868362  
Fax    
Email  drgurupraveens@sdmuniversity.edu.in  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Ayush Bhawan, B Block, GPO Complex, INA, New Delhi - 110023  
 
Primary Sponsor  
Name  Ministry of AYUSH 
Address  Ayush Bhawan, B Block, GPO Complex, INA, New Delhi - 110023 
Type of Sponsor  Government funding agency 
 
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 Guru Praveen S  SDM College of Medical Sciences and Hospital  SDM College of Medical Sciences and Hospital, Manjushree Nagar, sattur
Dharwad
KARNATAKA 
9740868362

gurupraveen100@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDMIEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Enhanced Standard care  Enhanced standard care, comprising routine medical management and educational materials on diabetes and cardiovascular risk management  
Intervention  Integrated Yoga with Standard care  • Integrated Yoga Program (consisting of loosening practices, Yogasanas, Pranayama & Meditation, dietary modification) along with standard treatment • 5 days in a week for one hour daily in the morning for 3 months under the supervision of authorized yoga instructor • In hospital sessions: weekly once  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Diagnosed with type 2 diabetes mellitus for at least 1 year, based on ADA criteria.
Willingness to provide informed consent and comply with trial procedures.
 
 
ExclusionCriteria 
Details  Systolic blood pressure greater than or equal to 139 mmHg and or diastolic blood pressure greater than 89 mmHg, or currently on antihypertensive medication.
History of cardiovascular disease.
Presence of neuromuscular disorders or joint pain that would interfere with the ability to perform yoga.
Regular practice of yoga (defined as greater than or equal to 2–3 hours per week) within the past 6 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in 10-year ASCVD risk score from baseline at 12 weeks and 24 weeks following the structured yoga lifestyle intervention in individuals with T2DM  Change in 10-year ASCVD risk score from baseline at 12 weeks and 24 weeks following the structured yoga lifestyle intervention in individuals with T2DM 
 
Secondary Outcome  
Outcome  TimePoints 
Immediate modulation of ASCVD-related gene expression in polymorphonuclear cells assessed after the 7-day yoga lifestyle training program.  baseline & 8th day 
Changes in glycemic parameters, lipid profile, & autonomic function   baseline, 12 weeks & 24 weeks 
Identification of molecular pathways (inflammation, oxidative stress, endothelial function) mediating the effect of yoga on ASCVD risk reduction in T2DM.   
Comparative performance of validated ASCVD risk prediction tools in estimating 10-year cardiovascular risk in individuals with T2DM   
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   10/02/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Type 2 diabetes mellitus (T2DM) is associated with a markedly increased risk of atherosclerotic cardiovascular disease (ASCVD), which remains the leading cause of morbidity and mortality in this population. Despite standard pharmacological management, a substantial residual cardiovascular risk persists, highlighting the need for complementary lifestyle-based interventions. Yoga, a traditional mind–body practice, has shown benefits in improving glycemic control, lipid profile, stress, and autonomic balance; however, its impact on composite ASCVD risk and underlying molecular mechanisms in individuals with T2DM has not been adequately studied.

The Yoga-AtheroCaRRe study is a prospective, randomized, open-label, blinded end-point (PROBE) trial designed to evaluate the efficacy of a structured yoga lifestyle intervention in reducing 10-year ASCVD risk in individuals with T2DM. A total of 150 participants will be randomized in a 1:1 ratio to receive either a structured yoga lifestyle program along with standard care or enhanced standard care alone. The intervention includes supervised yoga practices, breathing exercises, meditation, and lifestyle modifications.

Primary outcome is the change in 10-year ASCVD risk score at 3 and 6 months using validated risk prediction tools. Secondary outcomes include changes in glycemic status, lipid profile, psychosocial stress, autonomic function, endothelial function, inflammatory and oxidative stress markers, and ASCVD-related gene expression. This study aims to generate evidence on the clinical and molecular benefits of yoga as a sustainable adjunctive strategy for cardiovascular risk reduction in T2DM.

 
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