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CTRI Number  CTRI/2022/06/043103 [Registered on: 08/06/2022] Trial Registered Prospectively
Last Modified On: 02/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Study to Evaluate the effect of Kunjal Kriya with and without Yogic Diet in Class I Obesity 
Scientific Title of Study   A Comparative Clinical study to evaluate the effect of Kunjal Kriya with and without Yogic Diet in Class I Obesity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr NIMMI AN  
Designation  PG Scholar  
Affiliation  JSS Ayurveda Medical College,Mysuru 
Address  JSS Ayurveda Medical College and Hospital Lalithadripura road Alanahalli Mysuru Karnataka
JSS Ayurveda Medical College and Hospital Lalithadripura road Alanahalli Mysuru Karnataka
Mysore
KARNATAKA
570028
India 
Phone  9400610922  
Fax    
Email  nimmi8642@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPSUDHAKAR REDDY  
Designation  Professor  
Affiliation  JSS Ayurveda Medical College Lalitadripura road , Mysuru 
Address  Dept.of Swasthavritta JSS Ayurveda Medical College Lalitadripura road, Mysuru 570028
Lalitadripura Road, Mysuru 570028
Mysore
KARNATAKA
570028
India 
Phone  9916483919  
Fax  08212548361  
Email  drpsreddy05@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DrPSUDHAKAR REDDY  
Designation  Professor  
Affiliation  JSS Ayurveda Medical College Lalitadripura road , Mysuru 
Address  Dept.of Swasthavritta JSS Ayurveda Medical College Lalitadripura road, Mysuru 570028
Lalitadripura Road, Mysuru 570028
Mysore
KARNATAKA
570028
India 
Phone  9916483919  
Fax  08212548361  
Email  drpsreddy05@yahoo.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital, Lalithadripura , Mysuru ,Karnataka-570028 
 
Primary Sponsor  
Name  NIMMI A N 
Address  JSS Ayureda Medical College and Hospital, Mysuru 
Type of Sponsor  Other [other] 
 
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 P Sudhakar Reddy  JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL   YOGA & NATUROPATHY OPD ,JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, Lalithadripura Road, Mysuru, Karnataka 570028
Mysore
KARNATAKA 		 9916483919

drpsreddy05@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, MYSURU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E668||Other obesity,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kunjal kriya (Procedure Reference: Hathayoga pradeepika , Procedure details: Kunjal kriya will be carried out on empty stomach in the morning one time per day twice a week for four weeks i.e 8 times in 30 days. Kunjal kriya involves drinking 2 liters of lukewarm saline water until the subject feels nausea and then voluntarily vomits out the water. )
2Comparator Arm (Non Ayurveda)-kunjal kriya with yogic diet In this group along with Kunjal Kriya, subjects will be asked to follow a Yogic diet for one month
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Subjects between the age 20-45 years irrespective of gender and socio-economic status.
Subjects with obesity having BMI from 30 Kg/m2 to 34.99 Kg/m2 
 
ExclusionCriteria 
Details  Subjects of Class I Obesity with associated co-morbidities which interfere with the course of the treatment will be excluded.
Pregnant women and lactating mother will be excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
reduction of BMI ,1. BMI, Waist circumference, Hip waist ratio, Mid Arm circumference , Skin fold thickness
 		 0th day, 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
reduction in reduction of BMI ,1. BMI, Waist circumference, Hip waist ratio, Mid Arm circumference , Skin fold thickness
improvement in quality of life  		 60th day of treatment 
 
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)   15/06/2022 
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="6"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
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
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Publication article

  6. For how long will this data be available start date provided 04-12-0204 and end date provided 06-12-2028?
    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   it is an open labeled randomised interventional comparative  clinical study to evaluate the effect of Kunjal kriya with and without yogic diet in class I obesity. the primary outcome will be in relieving symptoms of obesity and secondary outcome will be reduction in body weight , BMI, Waist circumference and Lipid profile. in each group 30 subjects will be recruited and study duration will be 30 days. Kunjal kriya involves drinking of 5% saline water in the quantity of 250 ml and inducing vomiting  voluntarily . 
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