CTRI

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CTRI Number

CTRI/2024/07/069982 [Registered on: 04/07/2024] Trial Registered Prospectively

Last Modified On:

25/11/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Cluster Randomized Trial

Public Title of Study

To see the acceptability of the Ayurveda-based health care approach in the community and effectiveness of individualized health care

Scientific Title of Study

Acceptability of the comprehensive Ayurveda-based health care approach in the 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 Sunita
Designation	Research Officer
Affiliation	Central Council for Research in Ayurvedic Sciences
Address	Room No. 121 CCRAS, 61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi South West 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
Address	Room No. 121 CCRAS, 61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi South West 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
Address	Room No. 121 CCRAS, 61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi South West 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 CCRAS Ministry Of Ayush, Government Of India 61-65, opp. D Block, Janakpuri Institutional Area Janakpuri New Delhi Delhi 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 = 15
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
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 tejaswini.c@ccras.nic.in
Dr Sarada Ota	Central Ayurveda Research Institute, Bhubaneswar	Central Ayurveda Research Institute, AMHCP room, Bharatpur, Near Kalinga Studio,Bhubaneswar-751029, Dist- Khorda, Odisha Khordha ORISSA	9810425662 sarada_ota@yahoo.com
DrIndu PP	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	9495312570 dr.indupp@gmail.com
Dr Amit Madan	Central Ayurveda Research Institute, Guwahati	Central Ayurveda Research Institute ,AMHCP room, Borsojai, Beltola, Guwahati-781028 Kamrup ASSAM Kamrup ASSAM	7988244197 drmadanamit@gmail.com
Dr Ranjita Ekka	Central Ayurveda Research Institute, Kolkata	Central Ayurveda Research Institute, AMHCP room, 4-CN Block, Sector â€“ V, Bidhannagar, Kolkata 700 091 Kolkata WEST BENGAL Kolkata WEST BENGAL	7086510816 drranjitaekka@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 Delhiâ€“ 110 026 New Delhi DELHI West DELHI	8851677673 dr_seema_jain@yahoo.co.in
Dr Sangeeta Sangvikar	Central Ayurveda Research Institute, Patiala	Central Ayurveda Research Institute, AMHCP room, Patiala Moti Bagh Road, Patiala-147001 Patiala PUNJAB	7507203520 sangeetasangvi@gmail.com
Dr S Asha	Dr Achanta Lakshmipathi Regional Ayurveda Research Institute,Chennai	Dr Achanta Lakshmipathi Regional Ayurveda Research Institute, AMHCP room, 2nd Floor, VHS Campus, Taramani, Chennai. PIN 600 113 Chennai TAMIL NADU	9895192067 dr.ashas2324@gmail.com
Dr Shyam kale	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 shyam.kale5@gmail.com
DrParth 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 OverBridge, Asarwa,Ahmedabad-380004 Ahmadabad GUJARAT	9638948973 drppdave88@gmail.com
Dr Lijima	Regional Ayurveda Research Institute, Gangtok	Ayurveda Regional Research Institute,AMHCP room Tadung, Gangtok, Sikkim-737102 East SIKKIM East SIKKIM	9496707295 drlijima@gmail.com
Dr Amit Kumar	Regional Ayurveda Research Institute, Gwalior	Govt. Ayurvedic Hospital, AMHCP room, Amkho, Gwalior-474009 Gwalior MADHYA PRADESH Gwalior MADHYA PRADESH	9805997571 amitnegiayurveda@gmail.com
Dr Gopesh Sharma	Regional Ayurveda Research Institute, Jammu	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 Vanamala Wokde	Regional Ayurveda Research Institute, Nagpur	Regional Ayurveda Research Institute, AMHCP room, Near Gharkul Parisar,Near Venkatesh Nagar, NIT Complex Nandanwan, Nagpur â€“440009(Maharashtra) Nagpur MAHARASHTRA	9404669789 dr.vanmala.wakode789@gmail.com
Dr AJV Sai Prasad	Regional Ayurveda Research Institute, Vijayawada	Regional Ayurveda Research Institute, AMHCP room, New Rajiv Nagar,Payakapuram Vijayawada- 520015 Andhra Pradesh Krishna ANDHRA PRADESH Krishna ANDHRA PRADESH	9490716761 saiprasad_avvaru@yahoo.co.in

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 28
Name of Committee	Approval Status
Central Ethics Committee	Approved
IInstitutional Ethical committee of Regional Ayurveda Research Institute, Gwalior	Approved
Institutional Ethical committee of Central Ayurveda Research Institute, Bengaluru	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, Guwahati	Approved
Institutional Ethical committee of Central Ayurveda Research Institute, Kolkata	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, New Delhi	Approved
Institutional Ethical committee of Central Ayurveda Research Institute, Patiala	Approved
Institutional Ethical committee of Central Ayurveda Research Institute, Patiala	Approved
Institutional Ethical committee of Dr. Achanta Lakshmipathi Regional Ayurveda Research Institute, Chennai	Approved
Institutional Ethical committee of Dr. Achanta Lakshmipathi Regional Ayurveda Research Institute, Chennai	Approved
Institutional Ethical committee of National Ayurveda Research Institute for Panchakarma, Cheruthuruthy	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, Ahmedabad	Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Gangtok	Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Gangtok	Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Jammu	Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Jammu	Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Nagpur	Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Nagpur	Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Vijayawada	Approved
Institutional Ethical committee of Regional Ayurveda Research Institute, Vijayawada	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 in the comparator arm.
Patients	(1) ICD-10 Condition:K590\|\|Constipation. Ayurveda Condition: VIBANDHA, (2) ICD-10 Condition:N946\|\|Dysmenorrhea, unspecified. Ayurveda Condition: ARTAVAVAHA-SROTODUSHTIH, (3) ICD-10 Condition:J453\|\|Mild persistent asthma. Ayurveda Condition: SVASAH, (4) ICD-10 Condition:M179\|\|Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Lifestyle	-	-	Dinacarya: , Ritucarya: , Acara Rasayana:, Other:1)Comprehensive Ayurveda-based health care approach (CABHA) for 4 months : 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:
2	Intervention Arm	Lifestyle	-	-	Dinacarya: , Ritucarya: , Acara Rasayana:, Other:1)Comprehensive Ayurveda-based health care approach (CABHA) for 4 months: 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:

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 â€“ 1) Of age â‰¥18 years 2) Able to respond or communicate 3) Willing to participate in the survey For IAHA (Applicable only on Cluster -1) The families residing in the identified areas and consisting of at least 2 members and, at least one among them is aged â‰¥18 years â€¢ 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)
3) Head of the family does not consent for participation of any member

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, before and after the interventions(4 months) in the community

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)
2. Any change in the score of Immune Status Questionnaire (ISQ) in the participants from the included families
3.Any change in WHO-5 Wellbeing Index score of the participants from the included families
4.Any change in the score of Global Sleep Assessment Questionnaire (GSAQ) of the participants from the included families
5.Any change in the Oral Health Assessment Tool (OHAT) score of the participants from the included families
6.Any change in the scores of disease specific patient reported outcomes of the participants in the community (including selected families)
7.Proportion of participants adhering (â‰¥60%) to the Ayurveda advocacy and/or treatment throughout the duration of intervention
8.Trend in rise of OPD attendance in the outreach OPDs during the intervention period

1.to be assessed during baseline & end-line surveys
2.to be assessed at baseline, 60th day & 120th day
3.to be assessed at baseline, 30th day, 60th & 90th day
4.to be assessed at baseline, 60th day & 120th day
5.to be assessed at baseline, 60th day & 120th day
6.(Acute conditions: to be assessed at baseline, & as per the course of disease)
7.to be assessed at baseline, 30th day, 60th, 90th & 120th day.
8.4 months

Target Sample Size

Total Sample Size="7200"
Sample Size from India="7200"
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)

15/07/2024

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 Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

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 caste will be enrolled. The duration of study will be 12 months with a total sample size 7200 (480/ Centre for CABHA), 450 (30 families /30 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.