CTRI/2022/07/043683 [Registered on: 04/07/2022] Trial Registered Prospectively
Last Modified On:
21/03/2024
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Cross Sectional Study
Study Design
Cluster Randomized Trial
Public Title of Study
To determine the prevalence of Non-communicable Diseases) among Scheduled Tribes
Scientific Title of Study
“Cross sectional survey to determine the prevalence of Non-communicable Diseases and their risk factor among Scheduled Tribes in selected states across India.â€
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Kalpana B Kachare
Designation
Research Officer (Ayurveda)
Affiliation
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush
Address
Central Council for Research in Ayurvedic Sciences, Room No. 121,First Floor, 61-65, Opposite to D" Block , Janakpuri, New Delhi-110058
South West DELHI 110058 India
Phone
09834410028
Fax
Email
kachare.kalpana@gmail.com
Details of Contact Person Scientific Query
Name
Dr Kalpana B Kachare
Designation
Research Officer (Ayurveda)
Affiliation
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush
Address
Central Council for Research in Ayurvedic Sciences, Room No. 121,First Floor, 61-65, Opposite to D" Block , Janakpuri, New Delhi-110058
South West DELHI 110058 India
Phone
09834410028
Fax
Email
kachare.kalpana@gmail.com
Details of Contact Person Public Query
Name
Dr Kalpana B Kachare
Designation
Research officer (Ayurveda)
Affiliation
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush
Address
Central Council for Research in Ayurvedic Sciences, Room No. 121,First Floor, 61-65, Opposite to D" Block , Janakpuri, New Delhi-110058
South West DELHI 110058 India
Phone
09834410028
Fax
Email
kachare.kalpana@gmail.com
Source of Monetary or Material Support
central council for Research in Ayurvedic Sciences
Primary Sponsor
Name
Ministry of AYUSH
Address
New Delhi
Type of Sponsor
Government funding agency
Details of Secondary Sponsor
Name
Address
Nil
Nil
Countries of Recruitment
India
Sites of Study
No of Sites = 14
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr S Dodamani
Central Ayurveda Research Institute Bangalore
Central Ayurveda
Research Institute
Bangalore #12,
Uttarahalli Manavarthe
Kaval, Uttarahalli
(Hobli), Bangalore
South (Tq.) Kanakapura
Main Road,
Talaghattapura Post,
Bengaluru - 560109
Telephone: 080-295350
34(Office)/29635035(H
ospital)
Bangalore KARNATAKA
9448085818
shd_ayu@yahoo.co.in
Dr Purnedu Panda
Central Ayurveda Research Institute Bhuwaneshwar
THCRP room, Central
Ayurveda Research
Institute,
Bhubaneshwar,
Bharatpur, NearKalinga
Studio,
Bhubaneswar-751029,
Dist- Khorda, Odisha. Khordha ORISSA
9777852889
pandapurnendu02@yahoo.com
Dr Ekta Dogra
Central Ayurveda Research Institute Guwahati
Dr. Ekta Dogra,
Research Officer Ayu
Central Ayurveda
Research Institute
Guwahati, THCRP
Room, Borsojai,
Beltola,
Guwahati-781028.
Phone No.
0361-2303714 Kamrup ASSAM
7696863979
dr.ektadogra@gmail.com
Dr P Srinivas
Dr Achanta Lakshmipathi Regional Ayurveda Research Institute Chennai
Dr. P Srinivas,
THCRP ROOM, Dr. Achanta
Lakshmipathi Regional
Ayurveda Research
Institute, Chennai 2nd
Floor, VHS Campus,
Taramani, Chennai,
Tamilnadu. PIN:
600113. Chennai TAMIL NADU
9840879433
drsrinivaspitta@gmail.com
Dr Sojeetra Niral Hansraj
Regional Ayurveda Research Centre Agartala
Dr Sojeetra Niral
Hansraj, Regional
Ayurveda Research
Centre, Tripura 135,
Ramnagar Road, No.4,
Opp. Raj Bhandar
Agartala, Tripura –
799002 West Tripura TRIPURA
9574980226
sojitra.niral227@gmail.com
Dr Anil Avhad
Regional Ayurveda Research Institute Ahmadabad
Dr Anil Avhad, THCRP
Room, Regional
Ayurveda ResearchInstitute, Ahmadabad
Block A & D, 2nd Floor,
Bahumali Bhavan,
Manjushree Mill
Compound, Near
Girdharnagar Over
Bridge, Asarwa,
Ahmadabad-380004 Ahmadabad GUJARAT
9510176085
anilavhad4u@yahoo.com
Dr Ashok Sinha
Regional Ayurveda Research Institute Gangtok
Dr Ashok Sinha,
THCRP Room,
Ayurveda Regional
Research Institute,
Gangtok Tadung,
Gangtok,
Sikkim-737102 East SIKKIM
9466448410
drashoksinha22@gmail.com
Dr M M Sharma
Regional Ayurveda Research Institute Gwalior
Dr M M Sharma,
Research Officer
(AYU.) Regional
Ayurveda Research
Institute, Gwalior
THCRP Room, Govt.
Ayurvedic Hospital,
Amkho,Gwalior-474009
Madhya Pradesh Gwalior MADHYA PRADESH
9810691874
mmsharmajpr@gmail.com
Dr VBKumavat
Regional Ayurveda Research Institute Jaipur
Dr V.B.Kumavat
THCRP Room, M.S.
Regional Ayurveda
Research Institute
Jaipur, Indira Colony,
Bani Park, Jhotwara
Road, Jaipur-302016. Jaipur RAJASTHAN
8003514251
vinodbihari100@gmail.com
Dr Vipin Sharma
Regional Ayurveda Research Institute Jammu
Regional Ayurveda
Research Institute
Jammu Rajinder
Nagar,Ban Talab,
Jammu-181123 Phone
and Fax No.
0191-2546475, Jammu JAMMU & KASHMIR
9899437195
rariud.jammu@gmail.com
Dr S Namburi
Regional Ayurveda Research Institute Nagpur
Regional Ayurveda
Research Institute
Nagpur Near Gharkul
Parisar, Near
Venkatesh Nagar, NIT
Complex Nandanwan,
Nagpur – 440009
(Maharashtra) Phone
No. 0712-2714230 Nagpur MAHARASHTRA
8055595355
shilpasekhar2k5@yahoo.com
Dr Vimal Tiwari
Regional Ayurveda Research Institute Patana
Dr Vimal Tiwari,
THCRP Room,
Regional Ayurveda
Research Institute,
Patna RMRI Building
“D†Block, Agam Kuan,
Patna-800007 Patna
BIHAR Patna BIHAR
8176811914
vimalayuccras@gmail.com
Dr Abhay Dev
Regional Ayurveda Research Institute Port blair
Dr Abhay Dev,
Regional Ayurveda
Research Institute, Port
Blair Quarter No. NGII -
1/3, Chakkargaon (PO),
Opp. Municipal
Complex, Near Ganesh
Temple, Chakkargaon,
Port Blair, South
Andaman-744112, Andamans ANDAMAN & NICOBAR ISLANDS
9633180685
vimalayuccras@gmail.com
Dr K Nishanth
Regional Ayurveda Research Institute Vijaywada
Dr K Nishanth,
Regional Ayurveda
Research Institute
Vijayawada THCRP
Room New Rajiv
Nagar, Payakapuram
Vijayawada- 520015 Krishna ANDHRA PRADESH
9946307403
dr.nishanth.k@gmail.com
Details of Ethics Committee
No of Ethics Committees= 12
Name of Committee
Approval Status
Institutional Ethical committee of Central Ayurveda Research Institute Banglore
Approved
Institutional Ethical committee of Central Ayurveda Research Institute Bhubaneshwar
Approved
Institutional Ethical committee of Central Ayurveda Research Institute Guwahati
Approved
Institutional Ethical committee of Central Ayurveda Research Institute Guwahati(Agartala)
Approved
Institutional Ethical committee Reginal Ayurveda Research Institute Nagpur
Approved
Institutional Ethical committee Reginal Ayurveda Research Institute Patna
Approved
Institutional Ethical committee Reginal Ayurveda Research Institute Port Blair
Approved
Institutional Ethical committee Reginol Ayurveda Research Institute Vijayawada
Approved
Institutional Ethical Committee-Regional Ayurveda Research Institute Gangtok
Approved
Institutional Ethical Committee-Regional Ayurveda Research Institute Chennai
Approved
Institutional Ethical Committee-Regional Ayurveda Research Institute Gwalior
Approved
Institutional Ethical Committee-Regional Ayurveda Research Institute Jaipur
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
any gender, aged ≥18 years and belonging to Scheduled Tribe residing in the house surveyed in the selected colonies/areas.
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 gender, aged ≥18 years and belonging to Scheduled Tribe residing in the house surveyed in the selected colonies/areas.
ExclusionCriteria
Details
A person belonging to Scheduled Tribe but not Willing to participate.
A participant aged <18 years
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 Tribes 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
Single time data collection
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 (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
Single time data collection
Target Sample Size
Total Sample Size="3430" Sample Size from India="3430" Final Enrollment numbers achieved (Total)= "3430" Final Enrollment numbers achieved (India)="3430"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study is designed to determine the prevalence of NCD and their risk factor among Scheduled Tribes A field-based survey study will be carried out in the areas having residents belonging to Scheduled Tribe predominately. A study proforma to assess the socio-demographic profile, eating habits, exercise habits, Addictions, Present health status, and health-seeking behavior, will be developed. The houses in each selected colony will be numbered starting from the first house closest to the fixed landmark. House to house survey will be undertaken by a research team equipped with set-off instruments like a Weighting machine, measuring tap, Sphygmomanometer, a Stethoscope, etc.
At least five areas will be selected to cover 245 populations in each center (A total 3430 target populations for 14 institutes). After appropriate training, the weekly visits will be made by the research team in each area for a survey of the target population for 10 months. Information from the willing participants will be obtained after getting informed consent.
Participants above eighteen years of age belonging to Scheduled Tribe, residing in the selected areas will be included in the study.