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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--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:
2Comparator Arm (Non Ayurveda)-Routine LifestyleLifestyle 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

 
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