FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094203 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 02/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Study on Natural Therapies and Yoga to Enhance Psychological Health in CHD Patients 
Scientific Title of Study   Managing Psychological Well-being in Patients with Coronary Heart Disease through an Intervention Package of Nature Cure, Yoga, and Counseling 
Trial Acronym  MANAS-CHD (Mental And Naturopathic, Yogic Approach Study for CHD) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rupal Dilipbhai Gandhi 
Designation  PhD Scholar  
Affiliation  Lakulish Yog University 
Address  Lakulish Yoga University Lotus View, Near Balaji Temple, S.G. High Way, Chharodi, Ahmedabad-Gujarat, India


GUJARAT
382481
Other 
Phone  9898908568  
Fax    
Email  arogyadarbar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Aishwarya Jadeja 
Designation  PhD Guide 
Affiliation  Shankus Natural Health Centre 
Address  Lakulish Yoga University Lotus View, Near Balaji Temple, S.G. High Way, Chharodi, Ahmedabad- Gujarat, India


GUJARAT
382481
 
Phone  8160280177  
Fax    
Email  ashjadeja3@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rupal Dilipbhai Gandhi 
Designation  PhD Scholar  
Affiliation  Lakulish Yog University 
Address  Lakulish Yoga University Lotus Astang Yog Department, View, Near Balaji Temple, S.G. High Way, Chharodi, Ahmedabad-Gujarat, India


GUJARAT
382481
 
Phone  9898908568  
Fax    
Email  arogyadarbar@gmail.com  
 
Source of Monetary or Material Support  
Shankus Natural Health centre, (clinically driven NABH accredited Naturopathy Yoga Hospital), Shankus Water Park Campus, Ahmedabad Mehsana High way, Amipura -384435, Mehsana, Gujarat, India 
 
Primary Sponsor  
Name  Nisargopchar Yog Manav Utthan Cheritable Trust 
Address  Plot no.2142/B6, Nr. Gulista Ground, NCC Office, Hilldrive road,Bhavnagar - 364001, website - nymuct.org  
Type of Sponsor  Other [NGO] 
 
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 Chirag Andhariya  Shankus Natural Health Cente  Shankus Natural Health Centre, Naturopathy Yoga Section, Shankus Water Park Campus Ahmedabad Mahesana Highway Amipura 384435, Mehsana, Gujarat, India
Mahesana
GUJARAT 		 9099080026

dr.chirag.cmo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Lakulish Yoga University  Approved 
Shankus Natural Health Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, (2) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.Yogic Intervention 2. Nature Cure Intervention 3.Counseling  The intervention consists of a 12-week integrative program implemented as follows: •Frequency: One in-person session per week (including Yogic Intervention, Nature Cure Intervention, and Counseling) at Shankus Natural Health Centre, plus two additional online sessions each week. • Support: Continuous online assistance for self-naturopathy care at home, along with yoga guidance and counseling throughout the 12-week period. Yogic Intervention (40 minutes per session) 1. Aum Chanting – 5 min 2. Sukshma Vyayam (Joint Exercises) – 5 min 3. Asanas – 15 min o Makarasana (Crocodile Pose) o Bhujangasana (Cobra Pose, mild) o Setu Bandhasana (Bridge Pose, gentle) o Spinal Twisting 4. Anulom Vilom Pranayama (without Kumbhak) – 5 min 5. Shavasana (Relaxation) – 5 min 6. Breath Awareness – 5 min Nature Cure Intervention (40 minutes per session) 1. Hot & Cold Foot Bath – 10 min 2. Ghee Therapy for Both Feet – 5 min 3. Cold Compress on Spine – 10 min 4. Food-as-Medicine as per Naturopathy norms 5. Walking – 20 min Counseling Focus on self-awareness, emotional acceptance, stress management, decision-making, and coping strategies to improve psychological well-being and lifestyle modification. Sessions will address developmental concerns, crisis management, and behavioral adjustment.  
Comparator Agent  Usual medical care  CHD patients in the control group will continue usual medical care. Yogic intervention, nature cure intervention, and counseling will not be imparted. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects between 30 yrs. to70 yrs. of age of both the genders.
2. Subjects having CHD within last 1 yrs and are on medication.
3. Not taken Nature Cure & Yoga Treatment previously
 
 
ExclusionCriteria 
Details  1. Uncontrolled CHD
2. Subjects with, cerebral complications, renal disease or on Steroids and other critical Medical condition.
3. Patient having Psychiatric illness,
4. Subjects already practicing yoga therapy and Nature Cure treatment.
5. Pregnant women
6. Disabled person
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Outcome name: Psychological Well-Being (PWBS; Sisodia & Chaudhary) total score

Measure/units: PWBS standardized score 		 Baseline/12 week post intervention  
 
Secondary Outcome  
Outcome  TimePoints 
1.Systolic Blood Pressure (SBP) Units: mmHg
2.Diastolic Blood Pressure (DBP) Units: mmHg
3.Serum Cholesterol
Units: mg/dL
4.Serum Triglycerides
Units: mg/dL
 		 1.Systolic Blood Pressure (SBP)
o Timepoints: Baseline, 12 weeks
2.Diastolic Blood Pressure (DBP)
o Timepoints: Baseline, 12 weeks
3.Serum Cholesterol
o Timepoints: Baseline, 12 weeks
4.Serum Triglycerides
oTimepoints: Baseline, 12 weeks
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   04/10/2025 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [arogyadarbar@gmail.com].

  6. For how long will this data be available start date provided 04-10-2025 and end date provided 05-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Coronary heart disease CHD is often accompanied by psychological distress, which adversely impacts quality of life and clinical outcomes. This randomized controlled trial is designed to evaluate whether an integrative 12-week program of Nature Cure, Yoga, and Counseling can enhance psychological well-being and improve selected cardiometabolic markers in adults with CHD in Gujarat.

The study will enroll 60 adults (30–70 years) diagnosed with CHD within the last 12 months and currently on standard medication. Participants will be randomized into two groups:

  • Group 1 (Control) Standard medication and usual care.

  • Group 2 (Intervention) Standard medication plus a 12-week integrative program comprising one in-person session per week (Yoga practices, Nature Cure therapy, and counseling), two additional online sessions per week (Yoga and counseling), and continuous online support as per participant’s needs.

The Yoga module includes asanas, breathing practices, relaxation, and meditation. Nature Cure interventions include diet therapy based on naturopathy principles, selected hydrotherapy (e.g. hot & cold foot bath, cold spinal compress), ghee foot therapy, walking, and lifestyle counseling with dietary reinforcement.

Assessments will be conducted at baseline and week 12.

  • Primary Outcome: Change in Psychological Well-Being Scale score.

  • Secondary Outcomes: Blood pressure (systolic and diastolic) serum total cholesterol, serum triglycerides, and adverse events.

Randomization will use computer-generated variable permuted blocks, with allocation concealed in sequentially numbered opaque envelopes. Laboratory staff and the data analyst will remain blinded to group codes. Ethics approval has been obtained, and informed consent will be taken from all participants prior to enrollment.

 
Close