FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/02/049875 [Registered on: 20/02/2023] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A survey study of ayurvedic daily routines in school going children 
Scientific Title of Study   Evatuation of Knowledge, Attitude and Practice (KAP) of Dinacharya regimen among Highschool students in & around Belagavi - A Cross-Sectional Exploratory Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arpit Sah 
Designation  PG Scholar Department of Swasthavritta and Yoga 
Affiliation  KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya 
Address  KAHERs Shri B M Kankanwadi Ayurved Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9410707459  
Fax    
Email  aarpitsah@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Sagare 
Designation  Reader  
Affiliation  KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya 
Address  Reader Department of Swasthavritta and Yoga OPD number 2 and 17 KAHERs Shri B M Kankanwadi Ayurved Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9844586894  
Fax    
Email  sandeepsagare@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Sagare 
Designation  Reader  
Affiliation  KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya 
Address  Reader Department of Swasthavritta and Yoga OPD number 2 and 17 KAHERs Shri B M Kankanwadi Ayurved Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9844586894  
Fax    
Email  sandeepsagare@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003  
 
Primary Sponsor  
Name  Dr Arpit Sah 
Address  PG scholar Department of Swasthavritta and Yoga KAHERs Shri B M Kankanwadi Ayurved Mahavidyalaya Shahapur Belagavi 
Type of Sponsor  Other [Self sponsered PG dessertation ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arpit Sah  KLE Ayurvedic Hospital Belagavi  OPD 2 and OPD 17 Department of Swasthavritta and Yoga KAHERs Shri B M Kankanwadi Ayurved Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA 		 9410707459

aarpitsah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICAL COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HEALTHY SCHOOL STUDENTS 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Students studying in 8th, 9th & 10th standard of High Schools in and around the Belagavi
irrespective of age, sex, cast, religion.
Students willing to participate in the study.
 
 
ExclusionCriteria 
Details  Students studying in other than high schools.
Students absent at the time of data collection.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
High school students in and around Belagavi have good knowledge attitude and practice of Dinacharya regimen  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
NILL  NILL 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2023 
Date of Study Completion (India) 30/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   IT IS A CROSS SECTIONAL STUDY  

AIM To assess the knowledge, attitude and practice of Dinacharya among high school students in and around Belagavi

SAMPLE SIZE 400

STUDY PERIOD 18 MONTHS 

ASSESSMENT CRITERIA 
 
The assessment will be made on the basis of Standard Questionnaire
Dinacharya regimen will be assessed in terms of KAP score and obtained data will be put for statistical analysis
The questionnaire comprises of two sections. 
 Section 1 has six questions related to demographic data
Section 2 has 20 questions related to knowledge, 8 questions related to attitude and 24 questions related to practice of Dinacharya regimen
The Knowledge Attitude and Practice score will be assessed by giving one mark for each correct answer and zero mark for each incorrect answer
Knowledge score ranged from 0 to 20
Attitude score range from 0 to 8 
Practice score range from 0 to 24
Knowledge score ranges from 0 to 20
Out of 20 questions if a student responds 
less than 10 (below 50%) correct answers then it is considered as Poor Knowledge 
11-15 (50-75%) correct answers then it is Moderate knowledge 
15 (75%) correct answers then it is Good knowledge 
Attitude score ranges from 0 to 8
Out of 8 questions if a student responds 
less than 4 (below 50%) correct answers then it is considered as Poor level of Attitude towards Dinacharya practice
5-6 (50-75%) correct answers then it is considered Intermediate level of Attitude towards Dinacharya practice
less than 6 (75%) correct answers then it is considered as high level of Attitude towards Dinacharya practice
Practice score ranges from 0 to 24
Out of 24 questions if a student responds 
12 (<50%) correct answers then it is considered as Poor practice of Dinacharya
13-18 (50-75%) correct answers then it is considered Moderate practice of Dinacharya
above than 18 (75%) correct answers then it is considered as Good practice of Dinacharya.

METHODOLOGY
CRF containing Questionnaire on Dinacharya, Informed Consent Form (ICF) & Patient (participants) Information Sheet (PIS), will be prepared priorly. 
High Schools in and around Belagavi will be selected Randomly or by Lottery method.
Consent from Head Masters of the schools will be taken. 
Students from each school will be randomly selected and assent form will be collected from students. 
After getting assent, students will be involved in the study and survey will be done by providing a paper with questionnaire on Dinacharya. 


 
Close