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CTRI Number  CTRI/2022/09/045798 [Registered on: 23/09/2022] Trial Registered Prospectively
Last Modified On: 22/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   त्राटक का युवा वयस्कों के संज्ञानात्मक कार्यों पर प्रभाव  
Scientific Title of Study   EFFECT OF TRATAKA ON COGNITIVE FUNCTIONS IN YOUNG ADULTS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr ARTI YADAV 
Designation  ASSISTANT PROFESSOR 
Affiliation  UNIVERSITY OF PATANJALI 
Address  DEPARTMENT OF YOGA SCIENCE, UNIVERSITY OF PATNAJLI, HARIDWAR, UTTARAKHAND, INDIA-249405
UNIVERSITY OF PATNAJLI, HARIDWAR, UTTARAKHAND, INDIA-249405
Hardwar
UTTARANCHAL
249405
India 
Phone  9557710802  
Fax    
Email  arti@uop.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Kanchan  
Designation  Research Scholar 
Affiliation  University of Patanjali 
Address  DEPARTMENT OF YOGA SCIENCE, UNIVERSITY OF PATNAJLI, HARIDWAR, UTTARAKHAND, INDIA-249405
UNIVERSITY OF PATNAJLI, HARIDWAR, UTTARAKHAND, INDIA-249405
Hardwar
UTTARANCHAL
249405
India 
Phone  9627005572  
Fax    
Email  yadavkanchany@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kanchan  
Designation  Research Scholar 
Affiliation  University of Patanjali 
Address  DEPARTMENT OF YOGA SCIENCE, UNIVERSITY OF PATNAJLI, HARIDWAR, UTTARAKHAND, INDIA-249405
UNIVERSITY OF PATNAJLI, HARIDWAR, UTTARAKHAND, INDIA-249405
Hardwar
UTTARANCHAL
249405
India 
Phone  9627005572  
Fax    
Email  yadavkanchany@gmail.com  
 
Source of Monetary or Material Support  
Department of yoga science, University of Patanjali, Haridwar Uttarakhand, India-249405 
 
Primary Sponsor  
Name  University of Patanjali 
Address  University of Patanjali, Haridwar, Uttarakhand, India-249405 
Type of Sponsor  Other [University] 
 
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 
Kanchan Yadav  University of Patanjali  Department of yoga science, University of Patanjali, Haridwar
Hardwar
UTTARANCHAL 		 9627005572

yadavkanchany@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, University of Patanjali, Haridwar, Uttarakhand  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Volunteers 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Trataka (Procedure Reference: Tiwari et al., 2018, Procedure details: Experimental group will be given regular practice of Jyoti Tratka at the same time of the day for 8 weeks (each day 20 minutes practice which include 8 minutes relaxation period before and after practicing Tratka). )
2Comparator Arm (Non Ayurveda)-CONTROLControl group would be remain without intervention.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  1.Healthy participants both gender
2.Those people who will be willing to follow study conditions
3.Age between 18 to 24 years
 
 
ExclusionCriteria 
Details  1.Participants having cognitive impairment
2.Participants with a diagnosed illness
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
(i) Reaction Time
(ii) Attention

 
Reaction time and attention will be assessed (i) at baseline and (ii) after the intervention of 8 weeks(2 months). 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Perception
Optical Illusion
Learning 		 Time Points
(1). Baseline (T1)
(2). After the intervention (T2)
Duration of Intervention: 8 weeks (2 months) 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   25/09/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The objective of the present study is to assess the effect of trataka on cognitive functions in healthy young adults. In the present study participants of both gender having age range from 18 to 24 years will be recruited from University of Patanjali situated in north of India.  
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