| CTRI Number |
CTRI/2021/07/034752 [Registered on: 12/07/2021] Trial Registered Prospectively |
| Last Modified On: |
09/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Health Care survey of Women and Children of Scheduled caste community. |
|
Scientific Title of Study
|
“Profiling of Demographic, health status and Non communicable Diseases among Women and Child population of Scheduled Caste in selected states across India- A descriptive , Cross sectional Epidemiological study†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kishor Gavali |
| Designation |
Research Officer |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New
Delhi, Delhi 110058
61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New
Delhi, Delhi 110058
South West
DELHI
110058
India |
| Phone |
7011908354 |
| Fax |
|
| Email |
dr.kishorgavali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishor Gavali |
| Designation |
Research Officer |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New
Delhi, Delhi 110058
61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New
Delhi, Delhi 110058
DELHI
110058
India |
| Phone |
7011908354 |
| Fax |
|
| Email |
dr.kishorgavali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishor Gavali |
| Designation |
Research Officer |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New
Delhi, Delhi 110058
61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New
Delhi, Delhi 110058
DELHI
110058
India |
| Phone |
7011908354 |
| Fax |
|
| Email |
dr.kishorgavali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New
Delhi, Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeuti Rani Das |
Central Ayurveda Research Institute,Bhubaneswar |
Central Ayurveda Research Institute,
Borsojai (Bhetapara), Beltola,
Guwahati-781028, Assam
Kamrup
ASSAM |
9509192744
djeutirani@yahoo.in |
| Dr Susmita Priyadarshinee Ota |
Central Ayurveda Research Institute,Bhubaneswar |
At & Post – Bharat Pur, Near Kalinga Studio, Bhubaneswar-751029
Khordha
ORISSA |
8089375057
drsusmitaro@gmail.com |
| Dr Rinku Tomar |
Central Ayurveda Research Institute,Patiala |
Central Ayurveda Research Institute,
Moti Bagh Road, Patiala-147001
Patiala
PUNJAB |
9888685874
drrinkutomer2008@gmail.com |
| Vd Jaiprakash Ram |
Regional Ayurveda Research Institute, Ahmedabad |
Regional Ayurveda Research Institute,
Block A & D, 2nd Floor, Bahumali Bhavan,
Manjushree Mill Compound, Near Girdharnagar Over Bridge, Asarwa, Ahmedabad-380004
Ahmadabad
GUJARAT |
7791834211
jpram236@gmail.com |
| Dr SK Vedi |
Regional Ayurveda Research Institute, Jaipur |
M.S. Regional Ayurveda Research Institute
Indira Colony,
Bani Park, Jhotwara Road,
Jaipur-302016
Jaipur
RAJASTHAN |
9958426086
drskvedi@gmail.com |
| Dr Harit Kumari |
Regional Ayurveda Research Institute, Lucknow |
Regional Ayurveda Research Institute,
Plot No[dot]inS-106,
Sector -25,Near Sherwood Academy,
Indira Nagar Lucknow- 226 016
Lucknow
UTTAR PRADESH |
9837078947
drharit79@gmail.com |
| Dr Chris Antony |
Regional Ayurveda Research Institute, Mandi |
Regional Ayurveda Research Institute,
Siyog (Jaral) Pandoh, Tehsil Sadar, Distt. Mandi -175124 (H.P.)
Mandi
HIMACHAL PRADESH |
7807773464
chrisantony1@gmail.com |
| Dr PriyaAshokrao Thakare |
Regional Ayurveda Research Institute, Nagpur |
Regional Ayurveda Research Institute,
Near Gharkul Parisar,
Near Venkatesh Nagar,
NIT Complex Nandanwan. Nagpur-440009
Nagpur
MAHARASHTRA |
9175418356
ard123md@rediffmail.com |
| Dr Kuldeep |
Regional Ayurveda Research Institute, Patna |
Regional Ayurveda Research Institute,
D Block, Rajindra Memorial Res. Institute Building,
Agam Kuan, Patna-800007
Patna
BIHAR |
8954354560
doc.kuldeep@gmail.com |
| Dr Meghna P P |
Regional Ayurveda Research Institute, Thiruvananthapuram |
Regional Ayurveda Research Institute,
Poojapura
Thiruvananthapuram, -695012
Thiruvananthapuram
KERALA |
9495129282
drmeghnapp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee CARI, Guwahati |
Approved |
| Institutional Ethical Committee Central Ayurvedic Research Institute, Patiala |
Approved |
| Institutional Ethical Committee Central Ayurvedic Research Institute, Bhubaneshwar |
Approved |
| Institutional Ethical Committee MSRARI, Jaipur |
Approved |
| Institutional Ethical Committee RARI , Mandi |
Approved |
| Institutional Ethical Committee RARI, Ahmadabad |
Approved |
| Institutional Ethical Committee Regional Ayurvedic Research Institute, Lucknow |
Approved |
| Institutional Ethical Committee Regional Ayurvedic Research Institute, Nagpur |
Approved |
| Institutional Ethical Committee Regional Ayurvedic Research Institute, Patna |
Approved |
| Institutional Ethical Committee Regional Ayurvedic Research Institute, Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Any apparently healthy participant of Scheduled caste community willing to participate in the survey |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (3) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (4) ICD-10 Condition: J454||Moderate persistent asthma, (5) ICD-10 Condition: I619||Nontraumatic intracerebral hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Women and Children belonging to other than SC community |
|
| ExclusionCriteria |
| Details |
Women and Children belonging to other than SC community |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| i. Profiling of health status and non- communicable diseases in Women and Children of Scheduled Caste Population across selected states of India through a detailed structured questionnaire |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. To document the risk factors of NCDs through door to door survey method using structured questionnaires.
ii. To determine the Association between NCD’s and risk factors.
iii. To document the demographic profile of the SC population across the selected states in India in terms of age, gender, occupation etc.
|
baseline |
|
|
Target Sample Size
|
Total Sample Size="580000"
Sample Size from India="580000"
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)
|
12/07/2021 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
i. Profiling of health status and Non communicable Diseases like Hypertension, Diabetes
mellitus, Cancer, Asthma/COPD, Osteoarthritis in women’s of
Scheduled
Caste population in selected states
across India. ii. Demographic
profiling of Women and Children of Scheduled Caste population in selected states.
iii) Profiling of risk
factors of NCDs in women’s of Scheduled Caste population across
selected states of India. |