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CTRI Number  CTRI/2025/07/092020 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Nasya and Tarpan in Computer Vision Syndrome 
Scientific Title of Study   A comparative study to assess the role of tratak with pratimarsha nasya and tarpan kriya in computer vision syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amandeep Bharti 
Designation  Ayurvedic Medical Officer 
Affiliation  Government Ayurvedic Dsipensary, Longwal 
Address  Government Ayurvedic Dsipensary, V.P.D:Longwal Dist: Sangrur, Punjab

Sangrur
PUNJAB
148106
India 
Phone  9855276008  
Fax    
Email  dramandeepbharti85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amandeep Bharti 
Designation  Ayurvedic Medical Officer 
Affiliation  Government Ayurvedic Dsipensary, Longwal 
Address  Government Ayurvedic Dsipensary, V.P.D:Longwal Dist: Sangrur, Punjab

Sangrur
PUNJAB
148106
India 
Phone  9855276008  
Fax    
Email  dramandeepbharti85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amandeep Bharti 
Designation  Ayurvedic Medical Officer 
Affiliation  Government Ayurvedic Dsipensary, Longwal 
Address  Government Ayurvedic Dsipensary, V.P.D:Longwal Dist: Sangrur, Punjab

Sangrur
PUNJAB
148106
India 
Phone  9855276008  
Fax    
Email  dramandeepbharti85@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic Dsipensary, V.P.D:Longwal Dist: Sangrur, Punjab 
 
Primary Sponsor  
Name  Dr Amandeep Bharti 
Address  Government Ayurvedic Dispensary, Longwal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Harwinder Singh  Ayush Arogya Kendra, Kanakwal  Kanakwal,Bhanguan Punjab
Sangrur
PUNJAB 		 9781237511

harwinderbhangu88@gmail.com 
Sikander Sharma  Government Ayurvedic Dsipensary  , Longwal,
Sangrur
PUNJAB 		 9815186046

shrmsikande824@gmail.com 
Dr Gurupreet Singh  SLIET  Sant Longwal Institute of Engineering and Technology, Longwal
Sangrur
PUNJAB 		 9814008636

drgurpreet84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GURU RAVIDAS AYURVED UNIVERSITY PUNJAB, HOSHIARPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Working infornt of computer 3 hours or more 
Patients  (1) ICD-10 Condition:H534||Visual field defects. Ayurveda Condition: NETRAROGAH/AKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-10 minutes eye exercises (Procedure Reference: Article, Procedure details: Washing : 5 times Sunning : 3 minutes ( Sunning = closing the eyes, facing the sun & swaying the head left to right while breathing deeply.) Palming : Simple palming, Pressure & release palming, Palming with Bhramari pranayama. Swinging: 50 times Up & down (Vertical) Viewing : 10 to 20 times Right & left (Horizontal) Viewing:10 to 20 times Diagonal Viewing : 10 times each side. Rotational movement : 5 times clockwise & 5 times anti clockwise. Second week : above mentioned Trataka Savasanam (5 minutes). This is repeated till 45th day. Pratimarsha Nasya with Anutaila )
2Intervention ArmDrugClassical(1) Medicine Name: Anu Taila, Reference: Ashtang Hrudayam, Route: Nasal, Dosage Form: Taila, Dose: 02(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
3Comparator ArmProcedure-Netra Tarpana (Procedure Reference: Sushruta Samhita, Procedure details:  Phaltrikadi Ghrita for Akshi Tarpana will be taken for Tarpana karma according to the customized dose in order to drowning the eye lashes in it.  Three sittings of Akshi Tarpana with Phaltrikadi Ghrita by Tarpana Karma each for 7 days, with interval of 7 days will be given )
(1) Medicine Name: Phaltrikadi Ghrita, Reference: Ashtang Hrudayam, Route: Ocular, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 07 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  58.00 Year(s)
Gender  Both 
Details  Subjects who are working in front of visual display terminals at least 3 hours per day.
Study population : The survey will be conducted at Subjects working/studying in Sant Longowal Institute of Engineering & Technology (SLIET), Deemed University, Longowal, who are satisfying the inclusion and exclusion criteria also healthy individuals and patients visiting the OPD of Government Ayurvedic Dispensary, Longowal & AHWC Kanakwal Bhanguan who are suffering from symptoms of computer vision syndrome. 
 
ExclusionCriteria 
Details  1. Subjects suffering from infectious conditions of the eyes like conjunctivitis, stye, blepharitis etc.
2. Subjects with other systemic disorders, hypertension, thyroid disorders.
3. Subjects having any pathological conditions such as diabetic retinopathy, and hypertensive retinopathy
4. Subjects with History of any surgical intervention to eye.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The assessment will be done according to the findings of the subjective and objective criteria.
Structured questionnaire will be given to the subjects on the 0th and 46th day and symptoms will be assessed in 0-3 scale.
The Combined efficacy of the Tratak Procedure and the Pratimarsha Nasya will be assessed as it may be beneficial due to combined internal and external dosage form
 		 The assessment will be done according to the findings of the subjective and objective criteria.
Structured questionnaire will be given to the subjects on the 0th and 46th day and symptoms will be assessed in 0-3 scale.
 
 
Secondary Outcome  
Outcome  TimePoints 
The assessment will be done according to the findings of the subjective & objective criteria.
Structured questionnaire will be given to the subjects & the symptoms will be assessed in 0 to 3 scale at various intervals.
The Tarpan Kriya is the specified treatment mentioned for the eye ailments hence the better efficacy can be ascertained in the patients & healthy individuals effected with CVS 		 0 day Basleine
15th day Intermmediate
45th day After completion 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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 4 
Date of First Enrollment (India)   01/10/2025 
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="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  

Computer vision syndrome is the leading occupational health problem of the 21st century.50% to 90% of people who work at computer screen have at least some symptoms of eye trouble. In fact working adults aren’t the only ones vulnerable to computer vision syndrome. Kids who stare at portable video games or who use computers throughout the day at school also can experience eye problems related to computer use, especially if the lighting and computer position are less than ideal8. Computer vision syndrome affects some 90% of the people who spend 3 hours or more a day at a computer5. This may affect their performance, health, wellbeing and also may contribute to absenteeism. So there arises the essentiality of treatment to prevent the symptoms of computer vision syndrome. As per the symptoms it may be a vata pittaja disease.

 Yoga is an ancient science that brings together mind and body. Trataka provide strength to the ocular muscles, provide relaxation and increases lubrication4 Anutaila as pratimarsha nasya, is indicated to maintain the health of sense organs above the  neck. It can also be used for rejuvenating and nourishing the eyes. Tarpan Kriya kalpa is a proven therapy for the eye disorders and it will help in relieving the Vata aggravated due to the condition.

 

 

HYPOTHESIS

A.                Null hypothesis (H0)              : There is no difference between Tratak along with Anutaila pratimarsha nasya and Tarpan kriyakalpa in treating computer vision syndrome.

B.                 Alternate hypothesis (H1)      : Tratak along with Anutaila pratimarsha nasya is having significant effect in comparison with Tarpan kriyakalpa in treating computer vision syndrome..

 

1.         AIM AND OBJECTIVES

AIM

To assess the effect of Tratak along with Anutaila pratimarsha nasya and Tarpan kriyakalpa in computer vision syndrome

OBJECTIVE

§ To assess the effect of Tratak along with Anutaila prartimarsha nasya in reducing the symptoms of computer vision syndrome.

§ To assess the effect of Tarpan kriyakalpa in reducing the symptoms of computer vision syndrome

To compare the effect of Tratak along with Anutaila pratimarsha nasya and Tarpan kriyakalpa in computer vision syndrome.

 

RESEARCH QUESTION

§  Whether the application of Tratak along with Anutaila pratimarsha Nasya 2 drops, twice daily for a period of 45 days is effective in comparison to the Tarpan Kriya kalpa in reducing the symptoms of computer vision syndrome among the age group of 20 to 58 years?

 

2.         PLAN OF STUDY

1. Conceptual study: The scattered study and references from classical texts will be collected.

2. Clinical study:  A clinical study will be conducted on 220 Patients of Computer Vision Syndrome and healthy individuals for the period of 45 days.

PROTOCOL OF RESEARCH

1.         Ethical clearance will be taken from Institutional Ethical Committee.

2.         Informed written consent will be taken from each subject before the study.

3.         Case Record Form will be filled by taking detailed history followed by General, Physical and Systemic examination and various Parameters of Computer Vision Syndrome.

Study design  :           Randomized Clinical Trial

Study setting  :           The survey will be conducted at GAD Longowal, AHWC Kanakwal Bhanguan & Sant Longowal Institute of Engineering & Technology (SLIET), Deemed University, Longowal. and the subjects required for the study will be randomly selected.

Study population : The survey will be conducted at Subjects working/studying in Sant Longowal Institute of Engineering & Technology (SLIET), Deemed University, Longowal, who are satisfying the inclusion and exclusion criteria also healthy individuals and patients visiting the OPD of Government Ayurvedic Dispensary, Longowal & AHWC Kanakwal Bhanguan who are suffering from  symptoms of computer vision syndrome.

Study duration          : 45 days

Sample size                 : 110 (In each group)

No of Groups             : 2

Criteria of Selection  :

Diagnostic criteria

The subjects are selected on the basis of accepted criteria like headaches, blurred vision, neck, shoulder and back pain, fatigue, eye strain, eye redness and irritation, dry eyes, double vision, difficulty refocusing the eyes.

Inclusion criteria

1.    Subjects between the age group 20 to 58 years

2.    There is no sex discrimination

3.    Subjects who are working in front of visual display terminals at least 3 hours per day

 

Exclusion criteria

1.            Subjects suffering from infectious conditions of the eyes like conjunctivitis, stye, blepharitis  etc.

2.  Subjects with other systemic disorders, hypertension, thyroid disorders.

3.  Subjects having any pathological conditions such as diabetic retinopathy, and hypertensive retinopathy

4.  Subjects with History of any surgical intervention to eye.

Withdrawal criteria

·         At any point when subject wishes to withdraw from the study due to any personal inconvenience

At any point of the treatment, if the subject has any difficulty or unmanageable circumstances due to adverse effect of the procedure, he/she will be given necessary treatment and will not be further included in the study.
 
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