| CTRI Number |
CTRI/2022/09/045187 [Registered on: 02/09/2022] Trial Registered Prospectively |
| Last Modified On: |
29/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Profiling of Non-Communicable Diseases among health seekers approaching the OPD in selected Ayurveda health centres in Northeast India |
|
Scientific Title of Study
|
Non-Communicable Diseases and associated factors among health seekers approaching the selected Ayurveda health centres in Northeast 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 Mata |
| Designation |
Research Officer |
| Affiliation |
Central Council for Researchin 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.
South West
DELHI
110058
India |
| Phone |
8010529320 |
| Fax |
|
| Email |
sunita.dr@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Mata |
| Designation |
Research Officer |
| Affiliation |
Central Council for Researchin 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.
South West
DELHI
110058
India |
| Phone |
8010529320 |
| Fax |
|
| Email |
sunita.dr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Mata |
| Designation |
Research Officer |
| Affiliation |
Central Council for Researchin 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.
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 |
|
|
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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Ghuse |
NE Ayurveda Health Centr , Jorethang, Regional Ayurveda Research Institute, (RARI) Gangtok |
NE Room Near Fire Station, Daragaon, Naya Bazar, Jorethang, District -South Sikkim – 737121
South
SIKKIM |
9665927690
ghuserahul@gmail.com |
| Dr Rahul Ghuse |
NE Ayurveda Health Centre, Geyzing, Regional Ayurveda Research Institute, (RARI) Gangtok |
NE Room Pandey Colony, Near Geyzing Bazar, Geyzing,
District West Sikkim-737111
West
SIKKIM |
9665927690
ghuserahul@gmail.com |
| Dr Rahul Ghuse |
NE Ayurveda Health Centre, Mangan, Regional Ayurveda Research Institute, (RARI) Gangtok |
NE Room Rinzing Namgyal Marg, Mangan Nagar Panchayat,
Mangan Bazaar,
District North Sikkim - 737116
North
SIKKIM |
9665927690
ghuserahul@gmail.com |
| Dr Sudhanshu Kumar Meher |
NE Ayurveda Health centre , Doimukh Regional Ayurveda Research Institute (RARI) ITANAGAR |
NE Room Ayurveda Health centre,
Community Health Centre
Doimukh
Pincode-791112
Papum Pare
ARUNACHAL PRADESH |
09178009633
drmeher@rediffmail.com |
| Dr Sudhanshu Kumar Meher |
NE Ayurveda Health centre , Namsai Regional Ayurveda Research Institute (RARI) ITANAGAR |
NE Room Ayurveda Health centre,
District Hospital
Namsai
Pincode- 792103
Lohit
ARUNACHAL PRADESH |
09178009633
drmeher@rediffmail.com |
| Dr Sudhanshu Kumar Meher |
NE Ayurveda Health centre , Sagalee Regional Ayurveda Research Institute (RARI) ITANAGAR |
NE Room Ayurveda Health centre,
Community Health Centre,
Sagelee
Pincode- 791114
Papum Pare
ARUNACHAL PRADESH |
09178009633
drmeher@rediffmail.com |
| Dr Sudhanshu Kumar Meher |
NE Ayurveda Health centre , Seppa Regional Ayurveda Research Institute (RARI) ITANAGAR |
NE Room Ayurveda Health centre,District Hospital
Seppa
Pincode-790102
East Kameng
ARUNACHAL PRADESH |
09178009633
drmeher@rediffmail.com |
| Dr Sudhanshu Kumar Meher |
NE Ayurveda Health centre , Tezu Regional Ayurveda Research Institute (RARI) ITANAGAR |
NE Room Ayurveda Health centre, District Hospital
Tezu
Pincode-792001
Lohit
ARUNACHAL PRADESH |
09178009633
drmeher@rediffmail.com |
| Dr Rohit Kumar Ravte |
NE Ayurveda Health centre, Jirania, Regional Ayurveda Research Centre, Agartala, ( RARC )Tripura |
NE Room Ayurveda Health centre, Old Nagar Panchayat Office
Bankim Nagar (DasPara)
District-West Tripura
Pincode-799105
West Tripura
TRIPURA |
09007729430
rohitkravte@rediffmail.com |
| Dr Rohit Kumar Ravte |
NE Ayurveda Health centre, Kakraban, Regional Ayurveda Research Centre, Agartala, ( RARC )Tripura |
NE Room Ayurveda Health centre,
Kakraban
District- Gomati Tripura
Pincode-799105
South Tripura
TRIPURA |
09007729430
rohitkravte@rediffmail.com |
| Dr Masram Pravin Radhesham |
NE Ayurveda Health centre, Kamrup Central Ayurveda Research Institute (CARI) GUWAHATI |
NE Room Ayurveda Health centre, Umakanta and ChandrakantaGoswami PHC
Amranga-Barihat,
Mirza PS- Palasbari,
Mirza PO- Barihat
Dist: Kamrup, Assam
Pin code- 781125
Kamrup
ASSAM |
9624603204
Pravinmasram15@gmail.com |
| Dr Masram Pravin Radhesham |
NE Ayurveda Health centre, Nakhola Central Ayurveda Research Institute (CARI) GUWAHATI |
NE Room Ayurveda Health centre,
M.G. Model Hospital Nakhola
PO/PS- Jagiroad
Dist: Morigaon
Assam
Pin code- 782410
Marigaon
ASSAM |
9624603204
Pravinmasram15@gmail.com |
| Dr Masram Pravin Radhesham |
NE Ayurveda Health centre, Barpeta Central Ayurveda Research Institute (CARI) GUWAHATI |
NE Room Ayurveda Health centre, Barpeta
Bahari Mini PHC
PS- Tarabari
PO- Bahari
Dist- Barpeta, Assam
Pin code- 781302
Barpeta
ASSAM |
9624603204
Pravinmasram15@gmail.com |
| Dr Masram Pravin Radhesham |
NE Ayurveda Health centre, Dhula Central Ayurveda Research Institute (CARI) GUWAHATI |
NE Room Ayurveda Health centre, Dhula
Dhula NHPC
P.S.- Dhula PS
Dist: Darrang, Assam
Pin code- 78414
Darrang
ASSAM |
9624603204
Pravinmasram15@gmail.com |
| Dr Rohit Kumar Ravte |
NE Ayurveda Health centre, Moharcherra, Regional Ayurveda Research Centre, Agartala, ( RARC )Tripura |
NE Room Ayurveda Health centre,
Moharrcherra district
District – Khowai West Tripura
Tripura -799203
West Tripura
TRIPURA |
09007729430
rohitkravte@rediffmail.com |
| Dr Rohit Kumar Ravte |
NE Ayurveda Health centre, Santirbazar, Regional Ayurveda Research Centre, Agartala, ( RARC )Tripura |
NE Room Ayurveda Health centre, Santirbazar village
Ramraibari District
District- South Tripura
Pincode-799141
South Tripura
TRIPURA |
09007729430
rohitkravte@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Central Ayurveda Research Institute Guwahati |
Approved |
| Institutional Ethical Committee Regional Ayurveda Research Center, Tripura |
Approved |
| Institutional Ethical Committee Regional Ayurveda Research institute Itanagar |
Approved |
| Institutional Ethical Committee Regional Ayurveda Research institute, Gangtok |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Willing participants of any sex between 25 to 50 years age, attending the OPD of selected Ayurveda health centres in the Northeast India. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| i) Proportion of patients having clinical history of any non communicable disease among the health seekers attending the OPD of selected Ayurveda health centres in Northeast India |
i) Single time survey |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i.Assessment of Anthropometric measurements (height, weight, waist circumference and BMI); blood pressure and heart rate
ii.Assessment of physical activity score by Global physical activity questionnaire (GPHAQ)
iii.Assessment of sleeping habit of the patients [especially the habit of post-prandial day sleeping in lying down position (20min. for 3days/week since at least 3 months)]
iv.Assessment of eating habit of the patients (especially frequency of consumption of junk food &/or fast food, deep fried food, sea food, red meat; other unhealthy eating habits viz., adhyashan, atyashan, vishamashan as per Ayurveda classics)
v.Proportion of participants having psychological distress as assessed through Kessler Psychological Distress Scale (K10)
vi.Assessment of Prakriti (body constitution) through Prakriti Assessment Scale developed by CCRAS
vii.Assessment of Random Blood Sugar and Hemoglobin of the study participants through portable and digital glucometer and hemoglobinometer |
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 |
|
|
Target Sample Size
|
Total Sample Size="1070"
Sample Size from India="1070"
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)
|
14/09/2022 |
| 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="0"
Months="8"
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 associated factors among health seekers approaching the selected Ayurveda health centres in Northeast Indiaâ€.Its a cross sectional survey in which willing participants of any sex aged between 25 to 50 years age, attending the OPD of selected Ayurveda health centres in the Northeast India will be included and history will be taken regarding NCD. The duration of study will be 08 months with a total sample size of 1070(70/centre).Primary outcome of the study will be Proportion of patients having clinical history of any non communicable disease among the health seekers attending the OPD of selected Ayurveda health centres in Northeast India.
|