CTRI/2022/07/043637 [Registered on: 01/07/2022] Trial Registered Prospectively
Last Modified On:
04/07/2022
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 scheduled castes.
Scientific Title of Study
Cross sectional survey to determine the prevalence of Non-communicable Diseases and their risk factors among scheduled castes in selected states 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 = 20
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr S Asha
Captain Srinivasa Murthy Central Ayurveda Research Institute, Chennai
Dr.R.Ilavarasan
Assistant Director (S-III)
In-charge, Captain
Srinivasa Murthy
Central Ayurveda
Research
Institute,AMHCP room,
Arignar Anna
Government Hospital
Campus, Arumbakkam,
Chennai – 600 106 Chennai TAMIL NADU
9895192067
dr.ashas2324@gmail.com
Dr Thejaswini C
Central Ayurveda Research Institute, Bengaluru
Dr. Sulochana Bhat
Assistant Director
In-charge Central
Ayurveda Research
Institute,AMHCP room,
#12, Uttarahalli
Manavarthe Kaval,
Uttarahalli (Hobli),
Bangalore South (Tq.)
Kanakapura Main
Road, Talaghattapura
Post, Bengaluru
-560109 Bangalore KARNATAKA
9738222525
theju.tani99@gmail.com
Dr Gurucharan Bhuyan
Central Ayurveda Research Institute, Bhubaneswar
Central Ayurveda
Research
Institute,AMHCP room,
Bharatpur, Near
Kalinga Studio,
Bhubaneswar-751029,
Dist- Khorda, Odisha Khordha ORISSA
995835517
drbhuyangc@gmail.com
Dr Praveen Kumar K S
Central Ayurveda Research Institute, Guwahati
Central Ayurveda
Research Institute ,
AMHCP room, Borsojai,
Beltola,
Guwahati-781028 Kamrup ASSAM
9447506528
drpraveenkumarks@gmail.com
Dr Ranjita Ekka
Central Ayurveda Research Institute, Kolkata
Central Ayurveda
Research
Institute,AMHCP room,
4-CN Block, Sector – V,
Bidhannagar, Kolkata –
700 091 Kolkata WEST BENGAL
7086510816
drranjitaekka@gmail.com
Vd Sandipkumar
Central Ayurveda Research Institute, Patiala
Central Ayurveda
Research
Institute,AMHCP room,
Patiala Moti Bagh
Road, Patiala-147001 Patiala PUNJAB
9422540609
sandiprbaheti@gmail.com
Dr Seema Jain
Central Ayurveda Research Institute, Punjabi Bagh New Delhi
Central Ayurveda
Research
Institute,AMHCP room
Road No.66, Punjabi
Bagh(West) New Delhi
– 110 026 New Delhi DELHI
8851677673
drseemajain@yahoo.co.in
Dr SK Vedi
M.S. Regional Ayurveda Research Institute, Jaipur
M.S. Regional
Ayurveda Research
Institute
(RARI),AMHCP room,
Indira Colony, Bani
Park, Jhotwara Road,Jaipur-302016 Jaipur RAJASTHAN
9958426086
drskvedi@gmail.com
Dr Parvathy G Nair
National Ayurveda Research Institute for Panchakarma, Cheruthuruthy
The Director National
Ayurveda Research
Institute for
Panchakarma,
Cheruthuruthy, AMHCP
room,Thrissur District,
Kerala-679531, (India) Thrissur KERALA
9745886253
dr.parvathydev@gmail.com
Dr Amrish
Raja Ramdeo Anandilal Podar (RRAP) Central Ayurveda Research Institute, Mumbai
Raja Ramdeo Anandilal
Podar Central Ayurveda
Research Institute
(under CCRAS, Ministry
of AYUSH, Government
of India)AMHCP room,
Podar Medical Campus,
Dr. Annie Besant Road,
Worli, Mumbai-400018,
Maharashtra, India Mumbai MAHARASHTRA
9028638650
vdamrish@gmail.com
Dr Parth dave
Regional Ayurveda Research Institute, Ahmedabad
Dr. Kiran S.
Deshbhratar, Research
officer In-charge
Regional Ayurveda
Research
Institute,AMHCP room,
Ahmedabad Block A &
D, 2nd Floor, Bahumali
Bhavan, Manjushree
Mill Compound, Near
Girdharnagar Over
Bridge, Asarwa,
Ahmedabad-380004 Ahmadabad GUJARAT
9638948973
drppdave88@gmail.com
Dr Rahul Ghuse
Regional Ayurveda Research Institute, Gangtok
Ayurveda Regional
Research Institute,
AMHCP room Tadung,
Gangtok,
Sikkim-737102 East SIKKIM
Regional Ayurveda
Research Institute
under CCRAS, Ministry
of AYUSH, Government
of India),AMHCP room,
Rajinder Nagar,Ban
Talab, Jammu-181123 Jammu JAMMU & KASHMIR
9015947900
drgopeshsharma@rediffmail.com
Dr Alok Kumar Srivastava
Regional Ayurveda Research Institute, Lucknow
Regional Ayurveda
Research Institute,
AMHCP room, INS -106
Sector-25,Indira Nagar
Lucknow -226016 Lucknow UTTAR PRADESH
Institutional Ethical committee of Dr. Achanta Lakshmipathi Regional Ayurveda Research Institute, Chennai
Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Vijayawada
Approved
Institutional Ethical committee of Central Ayurveda Research Institute, Bengaluru
Approved
Institutional Ethical committee of Central Ayurveda Research Institute, Bhubaneswar
Approved
Institutional Ethical committee of Central Ayurveda Research Institute, Guwahati
Approved
Institutional Ethical committee of Central Ayurveda Research Institute, Kolkata
Approved
Institutional Ethical committee of Central Ayurveda Research Institute, New Delhi
Approved
Institutional Ethical committee of Central Ayurveda Research Institute, Patiala
Approved
Institutional Ethical committee of M.S. Regional Ayurveda Research Institute, Jaipur
Approved
Institutional Ethical committee of National Ayurveda Research Institute for Panchakarma, Cheruthuruthy
Approved
Institutional Ethical committee of Raja Ramdeo Anandilal Podar (RRAP) Central Ayurveda Research Institute, Mumbai
Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Ahmedabad
Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Gangtok
Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Gwalior
Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Jammu
Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Lucknow
Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Mandi
Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Nagpur
Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Patna
Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Thiruvananthapuram
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
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
Inclusion Criteria
Age From
18.00 Year(s)
Age To
90.00 Year(s)
Gender
Both
Details
Willing participants of any sex aged ≥18 years and belonging to Scheduled Caste residing in the house surveyed in the selected colonies/areas.
ExclusionCriteria
Details
Population other than Scheduled caste.
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 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) with incidence of NCDs.
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 heamoglobin (by digital Heamoglobinometer)
v.Assessment of physical activity score by Global physical activity questionnaire (GPHAQ)
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="3700" Sample Size from India="3700" 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 scheduled castes in selected states across
India.Its a cross sectional survey in which willing
participants of any sex aged ≥18 years and belonging to Scheduled Caste residing
in the house surveyed in the selected colonies/areas is being participated.The duration of study will
be 12 months with a total sample size of 3700(185/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 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) with incidence of NCDs.