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CTRI Number  CTRI/2024/09/073549 [Registered on: 06/09/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Guided Visual meditation (Trataka) and Eye Exercises on vision in Short sighted Adolescents 
Scientific Title of Study   Effect of Guided Trataka and Eye Exercises on Visual Acuity in Myopic Adolescents A Randomized Controlled Trial  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpa Ramesh Rathod  
Designation  B.A.M.S PG Scholar  
Affiliation  Government Ayurveda College and Hospital nagpur  
Address  OPD no.6, Swastharakshan Department, Government Ayurved college and Hospital, Sakkardhara Chowk, Raje Raghuji Nagar, Nagpur-440024, Maharashtra, India.

Nagpur
MAHARASHTRA
440024
India 
Phone  9975995348  
Fax    
Email  shilparathod680@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sumeeta S Jain 
Designation  Professor and HOD 
Affiliation  Government Ayurveda College and Hospital nagpur  
Address  OPD no.6, Swastharakshan Department, Government Ayurved college and Hospital, Sakkardhara Chowk, Raje Raghuji Nagar, Nagpur-440024, Maharashtra, India.

Nagpur
MAHARASHTRA
440024
India 
Phone  9373111200  
Fax    
Email  sumeetasjain@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shilpa Ramesh Rathod  
Designation  B.A.M.S PG Scholar  
Affiliation  Government Ayurveda College and Hospital nagpur  
Address  OPD no.6, Swastharakshan Department, Government Ayurved college and Hospital, Sakkardhara Chowk, Raje Raghuji Nagar, Nagpur-440024, Maharashtra, India.

Nagpur
MAHARASHTRA
440024
India 
Phone  9975995348  
Fax    
Email  shilparathod680@gmail.com  
 
Source of Monetary or Material Support  
OPD no.6, Swastharakshan Department, Government Ayurved college and Hospital, Sakkardhara Chowk, Raje Raghuji Nagar, Nagpur-440024, Maharashtra, India. 
 
Primary Sponsor  
Name  Shilpa Ramesh Rathod  
Address  Government Ayurveda College and Hospital Nagpur 
Type of Sponsor  Other [Self] 
 
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 Shilpa Ramesh Rathod  Government Ayurved Hospital and its periphery  OPD of Shalakyatantra Government Ayurved Hospital Raje Raghuji Nagar Sakkardhara Square,Nagpur ,Maharashtra
Nagpur
MAHARASHTRA 		 09975995348

shilparathod680@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee, Government Ayurveda College and Hospital, Nagpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vyAyAmaH, व्यायामः (Procedure Reference: Gherand samhita, Procedure details: Purva karma- 1.Prayer-2min 2.Relaxation by Deep breathing-5min Pradhan karma-Guided Trataka with breathing concentration First month -10min Second month -15 min Third month -20 min Paschat karma- Relaxation by Deep Breathing 3min )
2Comparator ArmProcedure-vyAyAmaH, व्यायामः (Procedure Reference: Gherand samhita, Procedure details: Purva karma- Relaxation by Deep breathing technique 5 min Pradhan karma- 1.Eye ball movement (Netrasanchalan) -10min Horizontal Direction for 10 Times-2min Vertical Direction for 10 Times Circular Direction for 10 Times 2.Shifting and Swinging of eyeball by thumb -2min 3.Blinking-Closing the eyes pausing for 2 sec then opening -2min 4.Palming-Cup your hand over each eye breath -3min deeply 10 min Paschat karma- Relaxation by deep breathing 5min )
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1.Subject with refractive index - 0.25 D to - 6D.
2.Those who are wearing Myopic Spectacle since minimum 2 month. 
 
ExclusionCriteria 
Details  1.Subject having refractive index more than – 6D.
2.Subject having any known systemic disorder like DM.
3.Subject having any other known ocular pathology like Hypermetropia.
4.Non co-operative subject 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To study effect of guided trataka and eye exercise on visual acuity in
myopic adolescents by snellen’s chart and autorefractometry.
 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To review literature of Regarding Trataka & Eye Exercise  24 weeks 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   10/09/2024 
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="6"
Days="5" 
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  
Title -Effect Of Guided Trataka  And Eye Exercises On Visual Acuity In Myopic Adolescents- A Randomized Controlled Trial

Aim-
To study effect of Guided Trataka and eye exercise on visual acuity in Myopic Adolescents.Objective
 
Primary objective
1. To study effect of guided Trataka with eye exercise on visual acuity in myopic adolescents by Snellen’s chart and autorefractometry.
2. To study effect of eye exercises on visual acuity in myopic adolescentsby snellen’s chart and autorefractometry.
3. To compare the effect of guided trataka along with eye exercise and only eye exercise on visual acuity in myopic adolesents by snellen’s chart and autorefractometry.
 Study design-Screening will be a done out of which 70 myopic Subjects  will be selected on the basis of criteria of selection. They will be randomly divided into two groups by lottery method after taking consent- Group A (study). 35 subject  will be given Guided trataka and eye exercise.Group B (Control): 35 subject will be given Eye Exercise . Assessment will be done by objective and subjective parameters. Screening will be done out of which 70 subject will be selected on the basis of criteria of selection.Statistical analysis with appropriate test and interpretation will be done.
Study population-70 Subject selected from school examine in shalakya OPD on the basis eligibility criteria.
Inclusion Criteria:
1.Age group 10 to16yr (Irrespective of sex)
2.Subject with refractive index - 0.25 D to - 6D.
3.Those who are wearing Myopic Spectacle since minimum 2 month.
 Exclusion Criteria:
1.Subject having refractive index more than – 6D.
2.Subject having any known systemic disorder like DM.
3.Subject having any other known ocular pathology like Hypermetropia.
4.Non co-operative subject.
 Withdrawal Criteria:
1. Unwilling Subject for trataka and eye exercise.


 
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