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CTRI Number  CTRI/2022/07/043699 [Registered on: 05/07/2022] Trial Registered Prospectively
Last Modified On: 01/07/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of Non Communicable Diseases and their risk factors among women belonging to scheduled castes. 
Scientific Title of Study   Cross sectional survey to determine the prevalence of Non Communicable Diseases and their risk factors among women belonging to scheduled castes across India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunita 
Designation  Research Officer 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS),Ministry of Ayush 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS) 61-65,Institutional Area,Opposite to D block,1st Floor,Room no.121,Janakpuri,New Delhi. DELHI 110058 India

South West
DELHI
110058
India 
Phone  8010529320  
Fax    
Email  sunita.dr@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunita 
Designation  Research Officer 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS),Ministry of Ayush 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS) 61-65,Institutional Area,Opposite to D block,1st Floor,Room no.121,Janakpuri,New Delhi. DELHI 110058 India

South West
DELHI
110058
India 
Phone  8010529320  
Fax    
Email  sunita.dr@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sunita 
Designation  Research Officer 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS),Ministry of Ayush 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS) 61-65,Institutional Area,Opposite to D block,1st Floor,Room no.121,Janakpuri,New Delhi. DELHI 110058 India

South West
DELHI
110058
India 
Phone  8010529320  
Fax    
Email  sunita.dr@rediffmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences,61-65,Institutional Area,Opposite to D block,1st Floor,Room no.121,Janakpuri,New Delhi. DELHI 110058 India 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  61-65, opp. D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Susmita P otta  Central Ayurveda Research Institute, Bhubaneswar  Central Ayurveda Research Institute Bharatpur, WCH Room, Near Kalinga Studio, Bhubaneswar-751029, Dist- Khorda, Odisha. Phone /Fax no: 0674-2387702 ,EPBX-200 Email:nria dd-bhubaneswar@gov.i n
Khordha
ORISSA 		 8089375057

drsusmitaro@gmail.com 
Dr Jeuti Rani Das  Central Ayurveda Research Institute, Guwahati  Central Ayurveda Research Institute, WCH Room, Borsojai, Beltola, Guwahati-781028. Phone No. 0361-2303714 Mobile No. 09435548209 Fax No. 0361-2303714 Email addr: neiari-guwahati@gov.in / neiari.guwahati@gmail .com
Kamrup
ASSAM 		 9509192744

djeutirani@yahoo.in 
Dr Rinku Tomar  Central Ayurveda Research Institute, Patiala  Central Ayurveda Research Institute, WCH Room, Patiala Moti Bagh Road, Patiala-147001 Phone: 0175-2306529 Telefax: 91-0175-2223663 Email: niapr-patiala@gov.in, niapr.patiala@gmail.com
Patiala
PUNJAB 		 9888685874

drrinkutomer2008@gmail.com 
Dr Jaiprakash  Regional Ayurveda Research Institute, Ahmedabad  Regional Ayurveda Research Institute, WCH Room, Ahmedabad Block A & D, 2nd Floor, Bahumali Bhavan, Manjushree Mill Compound, Near Girdharnagar Over Bridge, Asarwa, Ahmedabad-380004 Phone : 079-22682155, Fax:079-22683065 e-Mail: rarisd.amd-ayus h@gov.in, rarisd.ahmed abad@gmail.com
Ahmadabad
GUJARAT 		 7791834211

jpram236@gmail.com 
Dr Kishor Gavali  Regional Ayurveda Research Institute, Jaipur  M.S. Regional Ayurveda Research Institute (RARI),WCH Room, Indira Colony, Bani Park, Jhotwara Road, Jaipur-302016. Phone: 0141-2281812 Fax: 0141-2282618 E-mail: acri.jaipur@gma il.com(link sends e-mail), acri-jaipur@gov.in
Jaipur
RAJASTHAN 		 7011908354

dr.kishorgavali@gmail.com 
Dr Harit Kumari  Regional Ayurveda Research Institute, Lucknow  Regional Ayurveda Research Institute INS-106, Sector-25, WCH Room, Indira Nagar, Lucknow-226016 Telefax – 0522 2717801 Email – raried. lko@gmail.com(link sends e-mail), nvari.lko@gov.in(link sends e-mail)
Lucknow
UTTAR PRADESH 		 9837078947

drharit79@gmail.com 
Dr Chris Antony  Regional Ayurveda Research Institute, Mandi  Regional Ayurveda Research Institute,WCH Room, Gandhi Bhawan, Mandi-175001 (H.P.) Phone No. 01905-235236(Telefax), 01905-222857 e-Mail: arri-mandi@gov.in(link sends e-mail)
Mandi
HIMACHAL PRADESH 		 7807773464

chrisantony1@gmail.com 
Vd Priya Thakare  Regional Ayurveda Research Institute, Nagpur  Regional Ayurveda Research Institute,WCH Room, Near Gharkul Parisar, Near Venkatesh Nagar, NIT Complex Nandanwan, Nagpur – 440009 (Maharashtra) Phone No. 0712-2714230 Fax No. 0712-2714685 E-mail ID – amhri-nagpur@gov .in(link sends e-mail)
Nagpur
MAHARASHTRA 		 9175418356

ard123md@rediffmail.com 
Dr Ritika Mishra  Regional Ayurveda Research Institute, Patna  Regional Ayurveda Research Institute,WCH Room, RMRI Building “D” Block, Agam Kuan, Patna-800007, Tele-fax:0612-2631678, Telephone:0612- 2630903, E-mail id: arri. patna@gmail.com/arri-p atna@gov.in
Patna
BIHAR 		 9106511317

Dr.ritikamishra09@gmail.com 
Dr Meghna PP  Regional Ayurveda Research Institute, Trivandrum  Regional Ayurveda Research Institute,WCH Room, Poojappura, Thiruvananthapuram Kerala-695012 E-mail: r o.rarilsd-ayush[at]gov[d ot]in(link sends e-mail) Telephone : 0471-2340628 Telefax: 0471-2342070
Thiruvananthapuram
KERALA 		 9495129282

drmeghnapp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Institutional Ethics Committee of Central Ayurveda Research Institute ,Guwahati  Approved 
Institutional Ethics Committee of Central Ayurveda Research Institute, Bhubaneswar  Approved 
Institutional Ethics Committee of Central Ayurveda Research Institute, Patiala  Approved 
Institutional Ethics Committee of Regional Ayurveda Research Institute, Ahmedabad  Approved 
Institutional Ethics Committee of Regional Ayurveda Research Institute, Jaipur  Approved 
Institutional Ethics Committee of Regional Ayurveda Research Institute, Lucknow  Approved 
Institutional Ethics Committee of Regional Ayurveda Research Institute, Mandi  Approved 
Institutional Ethics Committee of Regional Ayurveda Research Institute, Patna  Approved 
Institutional Ethics Committee of Regional Ayurveda Research Institute,Nagpur  Approved 
Institutional Ethics Committee of Regional Ayurveda Research Institute,Trivandrum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prevalence of Non Communicable diseases 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  i.All the women of age 18 years and above belonging to Scheduled Caste residing in the house surveyed in the selected colonies/areas.
ii.Willing to participate in the study.
 
 
ExclusionCriteria 
Details  Population other than Scheduled caste women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
i.Proportion of participants having clinical history of any non communicable disease (Cardiovascular diseases, Cancer, Chronic respiratory diseases, Diabetes etc.) in the women of scheduled castes surveyed across India.
ii.Association of habit of post prandial day sleeping (for more than 20 minutes at least three times per week in last 3 months) and other related factors with incidence of NCDs in the study population
 		 i.Single time survey
ii.Single time survey

 
 
Secondary Outcome  
Outcome  TimePoints 
i.Assessment of living condition and socio-economic status
ii.Assessment of Anthropometric measurements (Height, weight, Waist circumference and BMI)
iii.Assessment of blood pressure and heart rate
iv.Assessment of Random blood sugar (by digital Glucometer) and hemoglobin (by digital Hemoglobinometer)
v.Assessment of physical activity score by Global physical activity questionnaire (GPAQ)
vi.Average number of servings of fruits and/or vegetables (with an average serving size of 80 gm) consumed by the study population
vii.Number of participants consuming tobacco (in any form) and alcohol
viii.Number of participants suffering from NCDs seeking health care through Ayurveda
 		 i.Single time survey
ii.Single time survey
iii.Single time survey
iv.Single time survey
v.Single time survey
vi.Single time survey
vii.Single time survey
viii.Single time survey
 
 
Target Sample Size   Total Sample Size="1700"
Sample Size from India="1700" 
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)   06/07/2022 
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="0"
Days="0" 
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 - NO
Brief Summary  

The present study is being conducted to assess the prevalence of Non communicable diseases and its risk factors among women belonging to scheduled castes across India.Its a cross sectional survey in which Women belonging to scheduled caste of age 18 years and above is being participated.The duration of study will be 12 months with a total sample size of 1700(170/centre).Primary outcome of the study will be ‘Proportion of participants having clinical history of any non communicable disease (Cardiovascular diseases, Cancer, Chronic respiratory diseases, Diabetes etc.) in the women of scheduled castes surveyed across India and ‘Association of habit of post prandial day sleeping (for more than 20 minutes at least three times per week in last 3 months) and other related factors with incidence of NCDs in the study population’.


 
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