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CTRI Number  CTRI/2024/07/070055 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 07/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Cluster Randomized Trial 
Public Title of Study   Assessment of acceptability of Ayurveda-based health care in the tribal community. 
Scientific Title of Study   Assessment of acceptability of the comprehensive Ayurveda-based health care approach in the tribal community and effectiveness of individualized health care - Cluster randomized study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kalpana Kachare 
Designation  Research Officer (Ayurveda) 
Affiliation  Central Council for Research in Ayurvedic Sciences, Ministry of Ayush  
Address  Dr.Kalpana Kachare, RO Ayu, Technical section Room No. 121,first floor, Central Council for Research in Ayurvedic Sciences, 61-65, Opposite to D" Block , Janakpuri, New Delhi

South West
DELHI
110058
India 
Phone  09834410028  
Fax    
Email  kachare.kalpana@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kalpana Kachare 
Designation  Research Officer (Ayurveda) 
Affiliation  Central Council for Research in Ayurvedic Sciences, Ministry of Ayush  
Address  Dr.Kalpana Kachare, RO Ayu, Technical section Room No. 121,first floor, Central Council for Research in Ayurvedic Sciences, 61-65, Opposite to D" Block , Janakpuri, New Delhi

South West
DELHI
110058
India 
Phone  09834410028  
Fax    
Email  kachare.kalpana@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kalpana Kachare 
Designation  Research Officer (Ayurveda) 
Affiliation  Central Council for Research in Ayurvedic Sciences, Ministry of Ayush  
Address  Dr.Kalpana Kachare, RO Ayu, Technical section Room No. 121,first floor, Central Council for Research in Ayurvedic Sciences, 61-65, Opposite to D" Block , Janakpuri, New Delhi

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(CCRAS), Janakpuri, New Delhi, India-110058 
 
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 = 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

nadri.bengaluru1@gmail.com 
Dr Purnedu Panda   Central Ayurveda Research Institute Bhubaneshwar   Dr Purnendu Panda, THCRP room, Central Ayurveda Research Institute, Bhubaneshwar, Bharatpur, NearKalinga Studio, Bhubaneswar-751029, Dist- Khorda, Odisha. Khordha ORISSA
Khordha
ORISSA 		 9777852889

pandapurnendu02@yahoo.com 
Dr P L Bharati  Central Ayurveda Research Institute Guwahati   Dr P L Bharati, Research Officer Ayu Central Ayurveda Research Institute Guwahati, THCRP Room, Borsojai, Beltola, Guwahati-781028. Phone No. 0361-2303714
Kamrup
ASSAM 		 9407587686

plbharati@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 		 840879433

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 Ahemadabad  Dr Anil Avhad, THCRP Room, Regional Ayurveda Research Institute, 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 Sreelakshmi  Regional Ayurveda Research Institute Gangtok  Dr Sreelakshmi, THCRP Room, Ayurveda Regional Research Institute, Gangtok Tadung, Gangtok, Sikkim-737102
East
SIKKIM 		 9207501869

sreelakshmirs069@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 V B Kumavat  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
Jaipur
RAJASTHAN 		 8003514251

vinodbihari100@gmail.com 
Dr Vipin Sharma  Regional Ayurveda Research Institute Jammu   Dr.Vipin Sharma, Research Officer Ayu, THCRP Room, Regional Ayurveda Research Institute Jammu, Rajinder Nagar, BanTalab, Jammu-181123
Jammu
JAMMU & KASHMIR 		 9899437195

rariud.jammu@gmail.com 
Dr U R Sekhar Namburi   Regional Ayurveda Research Institute Nagpur   Dr. U R Sekhar Namburi Research Officer Ayurveda Regional Ayurveda Research Institute Nagpur THCRP Room Near GharkulParisar, Near Venkatesh Nagar, NIT Complex Nandanwan, Nagpur – 440009 (Maharashtra)
Nagpur
MAHARASHTRA 		 8055595355

shilpasekhar2k5@yahoo.com 
Dr Ashok Sinha   Regional Ayurveda Research Institute Patana  Dr Ashok Sinha, THCRP Room, Regional Ayurveda Research Institute, Patna RMRI Building “D” Block, Agam Kuan, Patna-800007 Patna BIHAR Patna BIHAR
Patna
BIHAR 		 9466448410

drashoksinha22@gmail.com 
Dr Saroj Debnath  Regional Ayurveda Research Institute Port blair  Dr Saroj Debnath, 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 		 9477404010

rari.portblair@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
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Central Ethics Committee  Approved 
Institutional Ethical committee of Regional Ayurveda Research Institute Gwalior  Approved 
Institutional Ethical committee of Regional Ayurveda Research Institute Jaipur  Approved 
Institutional Ethical committee of Central Ayurveda Research Institute Banglore   Approved 
Institutional Ethical committee of Central Ayurveda Research Institute Bhuwaneshwar   Approved 
Institutional Ethical committee of Central Ayurveda Research Institute Guwahati   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Center Agartala   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Ahemadabad   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Chennai   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Gangtok   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Jammu   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Nagpur   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Patana  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Portblair  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Vijaywada   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals and patients both will be included in intervention arm as well as in the comparator arm 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, (2) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: ARTAVAVAHA-SROTODUSHTIH, (3) ICD-10 Condition:K590||Constipation. Ayurveda Condition: VIBANDHA, (4) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: SVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Other:1)Comprehensive Ayurveda-based health care approach (CABHA): a)Ancillary health care through Ayurveda through weekly out-reach OPDs b)Awareness regarding general health, healthy dietary and lifestyle modifications, nutrition, disease-wise counseling etc , Pathya/Apathya:no, Pathya:, Apathya:
2Intervention ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:1)Comprehensive Ayurveda-based health care approach (CABHA): a) Ancillary health care through Ayurveda through weekly out-reach OPDs b) Awareness regarding general health, healthy dietary and lifestyle modifications, nutrition, disease-wise counseling etc. 2) Individualized Ayurveda Health care Approach (IAHA): a) Holistic health care to each participating member in the included family will be given b)Apparently healthy adults will be encouraged , Pathya/Apathya:no, Pathya:, Apathya: The part, Pathya/Apathya:, Pathya:, Apathya:
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  For CABHA Eligibility Assessment for participation in the survey
1. Of age ≥18 years
2. Able to respond or communicate
3. Willing to participate in the survey

For IAHA (Applicable only on Cluster -1)
1.The families residing in the identified areas and consisting of at least 2 members and, at
least one among them is aged ≥18 years
2.At least one adult member in the family is willing to participate in this study for the 4 months
 
 
ExclusionCriteria 
Details  1. The families those are planning to move out of the identified area during the study
period.

2. Families whose members cannot dedicate any suitable time for the activities involved in
this study (personal interview and counseling) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Any change in perception & health-
seeking behavior of the selected
population after introduction of the
CABHA

(To be assessed through a questionnaire administered
among the randomly selected sample for survey in two
clusters of the community) 		 at baseline & after 4 Months 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1.Any change in the score of quality of life (SF-12) of the
surveyed participants
(including selected families) 		 SF-12 to be assessed during baseline &
120th day (end-line surveys) 
Any change in the score of Immune Status Questionnaire
(ISQ) in the participants from the included families 		 ISQ to be assessed at baseline, 60th day
& 120th day 
3.Any change in WHO-5 Wellbeing Index score of the
participants from the included families 		 WHO-5 to be assessed at baseline, 30th
day, 60th, 90th & 120th 
4.Any change in the score of Global Sleep Assessment
Questionnaire (GSAQ) of the participants from the included
families 		 GSAQ to be assessed at baseline, 60th day
& 120th day 
5.Any change in the Oral Health Assessment Tool (OHAT)
score of the participants from the included families 		 OHAT-5, to be assessed at baseline, 60th day
& 120th day 
6.Any change in the scores of disease specific patient
reported outcomes of the participants in the community
(including selected families) 		 Acute conditions: to be assessed at
30th,60th,90th & 120th 
7.Proportion of participants adhering (≥60%) to the
Ayurveda advocacy and/or treatment throughout the
duration of intervention 		 Participant adherence to be assessed at baseline, 30th
day, 60th, 90th, 120th, 150th & 180th
day. 
8.Trend in rise of OPD attendance in the outreach OPDs
during the intervention period 		 Four months 
 
Target Sample Size   Total Sample Size="7280"
Sample Size from India="7280" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   14/07/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
The present study is being conducted to assess the impact of comprehensive
Ayurveda-based health care approach (CABHA) and individualized Ayurveda health
care approach (IAHA) in the specified community. It is a Quasi-experimental study
design in which willing participants of any sex aged > 18 years and belonged to
scheduled Tribe will be enrolled. The duration of study will be 12 months with a
total sample size 7280 (520/ Centre for CABHA*14 center), 420 (30 families /28 Centre for
IAHA). There will be two clusters. In cluster 1 CABHA and IAHA will be given and in
cluster 2 only CABHA will be given for four months. Primary outcome will be
proportion of change in perception & health-seeking behavior of the selected
population after introduction of the CABHA and it will be assessed through a
questionnaire administered among the randomly selected sample for survey in two
clusters, before and after the interventions in the community.
 
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