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CTRI Number  CTRI/2025/02/081277 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   STHAULYA (OBESITY) AND THYROID FUNCTION  
Scientific Title of Study   TO FIND OUT ETIOLOGICAL FACTOR ACCOUNTABLE FOR STHAULYA ALONG WITH ROLE OF THYROID FUNCTION IN ITS MANIFESTATION A CROSS SECTIONAL STUDY  
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 BABITA JAMRA 
Designation  Pg Scholar Roga Nidan Evum Vikriti Vigyan  
Affiliation  Pt Khushilal Sharma Govt (Auto) Ayurveda College and Institute Bhopal 
Address  Science Hills Behind Manit Kolar Nehru Nagar Bypass Road Bhopal bhopal Madhya Pradesh 462003 India
Science Hills Behind Manit Kolar Nehru Nagar Bypass Road Bhopal Bhopal Madhya Pradesh 462003 India
Bhopal
MADHYA PRADESH
462003
India 
Phone  9179981470  
Fax    
Email  jamrababita0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RAJESH JAIN 
Designation  Lecturer Roga Nidan Evum Vikrati Vigyan Department 
Affiliation  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal 
Address  Science Hills Behind Manit Kolar Nehru Nagar Bypass Road Bhopal Madhya Pradesh 462003 India india
Science Hills Behind Manit Kolar Nehru Nagar Bypass Road Bhopal Madhya Pradesh 462003 India india
Bhopal
MADHYA PRADESH
462003
India 
Phone  9827730455  
Fax    
Email  rajeshjain1075@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR BABITA JAMRA 
Designation  Pg Scholar Roga Nidan Evum Vikriti Vigyan Department 
Affiliation  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal 
Address  Science Hills Behind Manit Kolar bypass Nehru Nagar Bhopal bhopal Madhya Pradesh 462003 India
Science Hills Behind Manit Kolar bypass Nehru Nagar Bhopal bhopal Madhya Pradesh 462003 India
Bhopal
MADHYA PRADESH
462003
India 
Phone  9179981470  
Fax    
Email  jamrababita0@gmail.com  
 
Source of Monetary or Material Support  
PT KHUSHILAL SHARMA GOVERNMENT AYURVEDIC AUTONOMOUS COLLEGE AND INSTITUTE BHOPAL 462003  
 
Primary Sponsor  
Name  Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal 
Address  Science Hills Behind Manit Kolar Nehru Nagar Bypass Road Bhopal Madhya Pradesh 462003 India 
Type of Sponsor  Research institution and hospital 
 
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 Babita Jamra  Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal  Roga Nidan Evum Vikrati Vigyan Department Room No 6 Science Hills Behind Manit Kolar Nehru Nagar Bypass Road Bhopal Madhya Pradesh 462003 India
Bhopal
MADHYA PRADESH 		 9179981470

jamrababita0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: STHULARUSHKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Participants having sign and symptoms of Obesity.
2. Participants between age group of 21 to 50 years either sex and irrespective of Socio-economic condition.
3. Participants having BMI (body mass index) between 25 to 35 kg/m² will be included in the study.
4. Participants willing to sign informed written consent forms for participation in the research study.
 
 
ExclusionCriteria 
Details  1. Patient not fulfilling the inclusion criteria.
2. BMI more than 35 and less than 25 kg/m².
3. Suffering from cardiac disease, pulmonary tuberculosis, severe lung diseases, severe, Hypertension, Diabetes mellitus, PCOD, pregnant and lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
At the end of the study, it is expected that we would be able to explore the To Evaluated the role of etiological factor and thyroid function test in case of sthoulya (obesity) An observation study.   12 months 
 
Secondary Outcome  
Outcome  TimePoints 
It is further expected that this study will be helpful in the clinical practice for the prevalence and treatment of this disease.  12 Months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/03/2025 
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 - NO
Brief Summary  

It is expected that we would be able to explore the To Evaluated the role of etiological factor and thyroid function test in case of sthoulya (obesity) An observation study. It is further expected that this study will be helpful in the clinical practice for the prevalence and treatment of this disease.

 
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