| CTRI Number |
CTRI/2024/10/074874 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ayurveda-Based lifestyle Advocacies and Practices in Children of Ekalavya Model Residential Schools in India |
|
Scientific Title of Study
|
Effectiveness of Ayurveda-Based lifestyle Advocacies and Practices on Quality of Life among Children of Ekalavya Model Residential Schools in India |
| 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 Prashant Shinde |
| Designation |
Research Officer (Ay) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
CCRAS
Room No 013, Ground Floor
JawaharLal Neharu bharatiya Chikitsa evam homeopathy Anusandhan Bhawan
No. 61-65 Institutional Areaopposite to D Block, Janakpuri CCRAS
Room No 013, Ground Floor
JawaharLal Neharu bharatiya Chikitsa evam homeopathy Anusandhan Bhawan
No. 61-65 Institutional Areaopposite to D Block, Janakpuri West DELHI 110058 India |
| Phone |
09623011214 |
| Fax |
|
| Email |
drprashantccras@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Renu Singh |
| Designation |
Research Officer (Ay) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
CCRAS
Room No 101, first Floor
Jawahar Lal Neharu Bharatiya Chikitsa evam homeopathy Anusandhan Bhawan
No 61-65 Institutional Area opposite to D Block Janakpuri CCRAS
Room No 101, first Floor
Jawahar Lal Neharu Bharatiya Chikitsa evam homeopathy Anusandhan Bhawan
No 61-65 Institutional Area opposite to D Block Janakpuri West DELHI 110058 India |
| Phone |
8826570500 |
| Fax |
|
| Email |
drrenusingh@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Renu Singh |
| Designation |
Research Officer (Ay) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
CCRAS
Room No 101, first Floor
Jawahar Lal Neharu bharatiya Chikitsa evam homeopathy Anusandhan Bhawan
No 61-65 instituttional Area, Opposite to D Block, Janakpuri CCRAS
Room No 101, first Floor
Jawahar Lal Neharu bharatiya Chikitsa evam homeopathy Anusandhan Bhawan
No 61-65 instituttional Area, Opposite to D Block, Janakpuri New Delhi DELHI 110058 India |
| Phone |
8826570500 |
| Fax |
|
| Email |
drrenusingh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences under Ministry of Ayush, Govt. of India
JawaharLal Neharu Bharatiya Chikitsa evam Homoepathy Anusandhan Bhawan
No. 61-65 Institutional Area, Opposite D Block, Janak Puri, New Delhi, 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Central Council for Research in Ayurvedic Sciences
Jawahar Lal Neharu Bharatiya Chikitsa evam Homeopathy Anusandhan bhavan
61-65 institutional area
Opposite to block D |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSHDoddamani |
CARI, Bengaluru |
Central Ayurveda Research Institute,
#12, Uttarahalli Manavarthe Kaval, Uttarahalli (Hobli), Bangalore South (Tq.) Kanakapura Main Road, Talaghattapura Post, Bengaluru – 560109
Bangalore KARNATAKA |
9448085818
shd_ayu@yahoo.co.in |
| Dr Purnendu Panda |
CARI, Bhubaneswar |
Central Ayurveda Research Institute,
At & Post – Bharat Pur, Near Kalinga Studio, Bhubaneswar-751029 Khordha ORISSA |
9777852889
pandapurnendu02@gmail.com |
| Dr SavitaPGopod |
Ekalavya Model Residential School, Y Ramavaram |
EMRS, Y. Ramavaram, Kakinada Division, Andhra Pradesh, Pin: 533483 Visakhapatnam ANDHRA PRADESH |
9177777631
savitagopod18@gmail.com |
| Dr S K Vedi |
MSRARI, Jaipur |
M.S. Regional Ayurveda Research Institute
Indira Colony, Bani Park, Jhotwara Road, Jaipur-302016 Jaipur RAJASTHAN |
9958426086
drskvedi@gmail.com |
| Dr Parth Prakashbhai Dave |
RARI, Ahmedabad |
Regional Ayurveda Research Institute, Ahmedabad
Block ‘A’ & ‘D’, Second Floor, Bahumali Bhavan, Manjushree Mill Compound, Nr. Girdharnagar Overbridge, Asarwa, Ahmedabad - 380 004 (Gujarat)
Ahmadabad GUJARAT |
9638948973
drppdave88@gmail.com |
| Dr Manisha Talekar |
RARI, Nagpur |
Regional Ayurveda Research Institute,
Near Gharkul Parisar, Near Venkatesh Nagar, NIT Complex Nandanwan. Nagpur-440009 Nagpur MAHARASHTRA |
8999107282
dr.mani21jan@gmail.com |
| Dr Savita P Gopod |
RARI, Vijaywada |
Regional Ayurveda Research Institute
New Rajiv Nagar, Payakapuram, Vijayawada-520 015 (A.P.), India
Guntur ANDHRA PRADESH |
9177777631
savitagopod18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| CARI, Bengaluru |
Approved |
| CARI_Bhubaneswar |
Approved |
| EMRS Y Ramavaram |
Approved |
| MSRARI_ Jaipur |
Approved |
| RARI, Ahmedabad |
Approved |
| RARI, Nagpur |
Approved |
| RARI, Vijayawada |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No congenital deformities, No deficiency diseases, no childhood disease, No developmental milestone
Between age group 15 – 18 years of either sex |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: IEC material will be provided for 12 Months, Ritucarya: IEC material will be provided for 12 Months, Acara Rasayana:IEC material will be provided for 12 Months, Other:Dashansanskar churna for Dantadhavan for 12 months; Til Taila for Padabhyanga for 12 months, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm (Non Ayurveda) | | - | Routine Lifestyle | Lifestyle as usual. |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
i. Apparently healthy participants (confirmed by clinical examination and health screening) with age between 15-18 years of either sex
ii. Willing to follow advocacies as advised for 1 year
iii. Willing to provide verbal assent
iv. School administration / Parents / Guardian willing to provide written consent
|
|
| ExclusionCriteria |
| Details |
i. Participants who are on regular medications for any Chronic medical conditions
ii. Any other condition that the investigator considers may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any change in Quality of life assessed through the PedsQol generic core scale |
at base line and 12th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any Change in Oral Health Assessment Tool (OHAT) score |
at Baseline, 6th, 12th month visits |
| Proportion of participants adhering more than 60 percentages Ayurveda-based lifestyle Advocacies and Practices throughout duration of intervention |
at every visit |
|
|
Target Sample Size
|
Total Sample Size="360" Sample Size from India="360"
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)
|
21/10/2024 |
| 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
|
In India, an estimated 77 million adults live with diabetes and the country currently has the second-highest number of people with diabetes in the world. Rapid urbanization and consequent lifestyle changes have led to an increased burden of NCDs and by 2030, there are expected to be 101 million adults with diabetes in India. Lifestyle refers to a set of behaviors that an individual engages in over a period, which may include both health-promoting and health-damaging practices. Individuals who embrace healthy lifestyle behaviors can withstand health risks linked to disability and disease in later life. Health-promoting behaviors are the foundation of disease prevention and maintaining a healthy life The fact that lifestyle behaviors are established early in life, in childhood and adolescence, and once established, they often persist into adulthood which accentuates the need to promote healthy practices in early life. Therefore, interventions to influence healthier lifestyles may be more effective if implemented in childhood, before unhealthy practices become entrenched in an individual’s lifestyle. Indulgence in increased unhealthy behaviors such as poor diet, physical inactivity, poor personal hygiene, poor interpersonal relationships, etc., has led to an increase in lifestyle-related problems such as obesity, diabetes, and heart diseases in later life. Children, who are still developing physically, mentally, and emotionally, are particularly vulnerable to these effects, which further emphasizes the importance of instilling positive healthy habits at a young age to ensure proper growth and development. Moreover, adopting healthy behaviors can improve academic performance, reduce mental health problems reinforce a positive attitude toward life. School period is found to be an appropriate time for instilling positive attributes and hence school is an appropriate venue to provide the young ones with skills to improve their healthy style behaviors. Studies done in India show a high prevalence of various risk factors related to NCDs among school children. Several school-based interventions to assess the impact of nutrition, lifestyle, and physical education interventions on overweight and obesity in children have been done in the past in developed countries. A few school-based interventions that have been done in India have focused mainly on the urban population. Despite the efforts of various stakeholders, unhealthy behaviors and lifestyle-related health problems among children remain a major challenge. Various interventions have already been implemented; however, their effectiveness and long-term sustainability remain unclear. Ayurveda, a system of medicine that originated in the Indian subcontinent, can play a major role in this aspect. The primary aim of Ayurveda is to prevent diseases by following a healthy lifestyle. Ayurvedic approach to a healthy lifestyle includes dinacharya (daily regimen for healthy living), Ritucharya (seasonal regimen for healthy living), Sadvaritta (moral conduct), and Achara Rasayana (social conduct) as well-established guidelines for healthy dietary practices. Research has shown the positive results of Ayurveda Intervention, Lifestyle modification, and yoga in prediabetic and diabetic patients. Till now no studies to our knowledge that are based on Ayurveda advocacies for healthy lifestyles have been undertaken targeting children and adolescents. Based on the understanding of the early introduction of positive practices, the present study has been conceptualized with a specific purpose to evaluate the effect of Ayurveda-based lifestyle advocacies and Practices comprising of a multi-component model centered around approaches of Dincharya (daily regimen), Ritucharya (seasonal regimen), Ahar Vidhi Vidhan (dietary behavior), Sadvritta (Mode of conduct) and Yogasana for promoting a holistic healthy lifestyle with an aim of improving quality of life and physical activity among children and adolescents (aged 10 – 18 years) of Eklavya Model Residential Schools. The positive implication of ayurveda based life style advocacies and practices will observed in the students of EMRSs |