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CTRI Number  CTRI/2025/02/080410 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 25/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Single Arm Study 
Public Title of Study   To find out the effect of yoga and naturopathy including diet in metabolic syndrome patients 
Scientific Title of Study   EFFECT OF YOGA AND NATUROPATHY INCLUDING PLANT-BASED DIET ON CARDIOMETABOLIC PARAMETERS IN METABOLIC SYNDROME PATIENTS: A SINGLE GROUP PRE-POST DESIGN 
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 P Keerthi 
Designation  PG Scholar 
Affiliation  Government yoga and naturopathy medical college and hospital 
Address  DEPT of naturopathy, Second floor, Government yoga and naturopathy medical college and hospital, PG block, Arumbakkam

Chennai
TAMIL NADU
600106
India 
Phone  8778858007  
Fax    
Email  keerthipugal2099@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAMooventhan 
Designation  Assistant Medical Officer cum Lecturer,Department of research 
Affiliation  Government yoga and naturopathy medical college and hospital 
Address  DEPT of research, Second floor, Government yoga and naturopathy medical college and hospital, PG block, Arumbakkam, Chennai-106, Tamilnadu

Chennai
TAMIL NADU
600106
India 
Phone  9844457496  
Fax    
Email  dr.mooventhan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr P Keerthi 
Designation  PG Scholar 
Affiliation  Government yoga and naturopathy medical college and hospital 
Address  DEPT of naturopathy, Second floor, Government yoga and naturopathy medical college and hospital, PG block, Arumbakkam

Chennai
TAMIL NADU
600106
India 
Phone  8778858007  
Fax    
Email  keerthipugal2099@gmail.com  
 
Source of Monetary or Material Support  
Government yoga and naturopathy medical college and hospital,Arumbakkam,Chennai-106 
 
Primary Sponsor  
Name  Government Yoga and Naturopathy Medical College and Hospital 
Address  Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai-600106 
Type of Sponsor  Government medical college 
 
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 keerthi  Government yoga and naturopathy college and hospital.  2nd floor, Department of naturopathy, Post Graduate block, Arumbakkam, Chennai-106
Chennai
TAMIL NADU 		 8778858007

keerthipugal2099@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government yoga and naturopathy medical college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E70-E88||Metabolic disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrated yoga and naturopathy including plant-based diet  The total duration of intervention will be for 10 days. Four asanas and pranayama will be practiced daily. Enema will be given twice for 10 days. Hydrotherapy treatments such as Gastro hepatic pack will be given daily, Cold hip bath and mud pack to abdomen and eyes will be given for alternate days. Plant-based diet will be given for days for three a time daily. 
Comparator Agent  no  no 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Age between 35 and 65 years.
2) Both males and females
3) Patient with the following diagnostic criteria of National Cholesterol Education
Program (NCEP) 
 
ExclusionCriteria 
Details  1) Patients with psychiatric disorders
2) Pregnant and lactating mothers
3) Patients undergoing any other physical therapy
4) Patients with recent surgical intervention (past 3 month)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fasting blood sugar, Post prandial blood sugar, Lipid profile, Blood pressure  Fasting blood sugar, Post prandial blood sugar, Lipid profile, Blood pressure will be measured before and after the intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
waist-hip ratio, Body Mass Index (BMI),Framingham risk score (FRS)  waist-hip ratio, Body Mass Index (BMI),Framingham risk score (FRS) before and after 10 days of intervention 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/03/2025 
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="1"
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

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [keerthipugal2099@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 02-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   A single group pre post study design will be used for this study. All participants will undergo residential Yoga and Naturopathy including Plant-based diet for a period of 10 days. Yoga and naturopathy intervention includes 4 asanas and pranayama, enema, GH pack, CHB, mud pack Assessments will be taken before and after the intervention. The primary outcome measure will be biochemical parameters. The secondary outcome measure will be anthropometric measurements, Framingham risk score (FRS), Quality of life (QoL)-SF-36, Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). 
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