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CTRI Number  CTRI/2024/05/067642 [Registered on: 20/05/2024] Trial Registered Prospectively
Last Modified On: 16/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Survey on prevalence of lifestyle disorders in people taking food timely and lately 
Scientific Title of Study   Prevalence of Metabolic Syndrome in Kala Bhoji and Atita Kala Bhoji subjects-An Analytical 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  Sneha John 
Designation  P.G Scholar 
Affiliation  Ch.Brahm Prakash Ayurved Charak Sansthan 
Address  Room no-222,PG Dept.of Swasthavritta,2nd floor Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi

South West
DELHI
110073
India 
Phone  7025002601  
Fax    
Email  s4snehajohn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Unnikrishnan S 
Designation  Head of the Department 
Affiliation  Ch.Brahm Prakash Ayurved Charak Sansthan 
Address  Room no-232,PG Dept.of Swasthavritta,2nd floor Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi

South West
DELHI
110073
India 
Phone  07025002601  
Fax    
Email  drunnikrishnans@gmail.com  
 
Details of Contact Person
Public Query  
Name  Unnikrishnan S 
Designation  Head of the Department 
Affiliation  Ch.Brahm Prakash Ayurved Charak Sansthan 
Address  Room no-232,PG Dept.of Swasthavritta,2nd floor Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi

South West
DELHI
110073
India 
Phone  07025002601  
Fax    
Email  drunnikrishnans@gmail.com  
 
Source of Monetary or Material Support  
Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi.110073 
 
Primary Sponsor  
Name  Ch.Brahma Prakash Ayurved Charak Sansthan 
Address  Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi Pin-110073 
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 Sneha John  Ch.Brahm Prakash Ayurved Charak Sansthan  Room no.222 PG Dept.of Swasthavritta 2nd floor institute block Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi-110073
South West
DELHI 		 7025002601

s4snehajohn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee,Ch.Brahma Prakash Ayurved Charak Sansthan  Approved 
Institutional Review Board, Chaudhary Brahm Prakash Ayurved Charak Sansthan,New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subjects taking Kala bhojana and Atita kala bhojana 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)The subjects of any gender who are willing to join the survey
2)The subjects of age group 18-60 years without any discrimination of gender,caste,religion,occupation and socio economic status
3)Subjects with informed consent to participate in the study 
 
ExclusionCriteria 
Details  1)Persons who will not fulfil the inclusion criteria
2)Pregnant and lactating mothers
3)Patients with comorbidities like carcinoma 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Prevalence of metabolic syndrome in kala bhoji and atita kala bhoji subjects is estimated  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Association between metabolic syndrome with kala bhojana & atita kala bhojana will be estimated  8 weeks 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   05/06/2024 
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   The study will be conducted among nearby areas of CBPACS,New Delhi,between the age group of 18-60 years of different socioeconomic status and also among the OPD and IPD  of 18-60 years  at CBPACS,New Delhi.Prevalence of Metabolic syndrome with reference to Vishamasana (Kala bhojana and atita kala bhojana) will be assessed.A detailed questionnaire proforma will be prepared and the participants will be interviewed by face to face interview method.Questionnaire contents will be composed in the manner that it can capture demographic details such as name,age,sex,educational background ,income,as well as daily food consumption habit like the timing of daily food with reference to atita kala bhojana and kala bhojana. It also collect the data related to working hours,physical activity,sleeping hours,alcohol consumption,smoking habit etc along with past medical history,family history,co-morbidity and clinical data of the study participants. 
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