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CTRI Number  CTRI/2022/07/044042 [Registered on: 15/07/2022] Trial Registered Prospectively
Last Modified On: 14/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effect of Jal Neti and Nadi Shodhan Pranayama in Glaucoma 
Scientific Title of Study   Effect of Jal Neti and Nadi Shodhan Pranayama (Anuloma-viloma Pranayama) on the clinical parameters of patients with primary open angle glaucoma (POAG) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayvindra Singh 
Designation  Research Scholar 
Affiliation  University of Patanjali 
Address  University of Patanajli Patanjali Yogpeeth

Hardwar
UTTARANCHAL
249405
India 
Phone  9536011319  
Fax    
Email  jayrana319@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr VK Katiyar 
Designation  Professor 
Affiliation  University of Patanjali 
Address  University of Patanjali, Patanjali Yogpeeth,Bahadrabad

Hardwar
UTTARANCHAL
249405
India 
Phone  9897000998  
Fax    
Email  vktmafma20@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr VK Katiyar 
Designation  Professor 
Affiliation  University of Patanjali 
Address  University of Patanjali, Patanjali Yogpeeth,Bahadrabad

Hardwar
UTTARANCHAL
249405
India 
Phone  9897000998  
Fax    
Email  vktmafma20@gmail.com  
 
Source of Monetary or Material Support  
University of Patanjali, Haridwar 
 
Primary Sponsor  
Name  University of Ptatanjali 
Address  University of Patanjali, Patanjali Yogpeeth, Haridwar, Uttarakhand 
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 
Jayvindra Singh  University of Patanjali  Department of Yoga Science, University of Patanjali, Patanjali Yogpeeth, Haridwar
Hardwar
UTTARANCHAL 		 9536011319

jayrana319@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, University of Patanjali  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H401||Open-angle glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anuloma viloma pranayama, jala neti  Anuloma viloma pranayama and jala neti are yoga practices. 
Comparator Agent  Control  No intervention will be given to the participants who are not assigned to active intervention.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  (i) Persons with ages between 40 and 65 years
(ii) Patients diagnosed with primary open angle glaucoma and currently on eye drop medication
(iii) Persons willing to take part in the study 
 
ExclusionCriteria 
Details  (i) Patients with history of intraocular surgery/laser in previous 3 months, malignancy, ocular trauma, angle closure glaucoma.
(ii) Patients having any systemic disease (diabetes mellitus, hypertension, hyperthyroid etc).
(iii) Patients taking part in any other research study involving yoga or other mind body interventions. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
(i) Intra ocular pressure
(ii) Visual fields
(iii) Optical coherence tomography
(iv) Visual acuity test 		 Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
(i) Intra ocular test
(ii)Visual field
(iii) Optical coherence tomography
(iv) Visual acuity test 		 3 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   18/07/2022 
Date of Study Completion (India) 30/12/2023 
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)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Effect of yoga on intra-ocular pressure in patients with glaucoma: A systematic review and meta-analysis 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jayrana319@gmail.com].

  6. For how long will this data be available start date provided 01-08-2023 and end date provided 01-08-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Globally the prevalence of glaucoma is 3.54 percent for the population aged 40 to 80 years and is expected to increase from 76 million to 111.8 million individuals between 2020 and 2040. The pharmacological treatment of glaucoma mainly involves reducing the elevated IOP levels with drugs such as alpha-agonists, prostaglandins and β-blockers, although the envisaged results of the current medical regimen are not satisfying and sufficient. In recent years, an increased interest of using complementary and alternative therapies is seen for the treatment of glaucoma. Yoga is one of the most popular and widely used non-pharmacological interventions mainly comprising of practices involving breathing manipulation (pranayama), physical postures (asana) and mental awareness or meditation (dhyana). The evident effects of yoga on stress reduction, improvement of quality of life and general wellbeing could make it a relatively safe and economical add on treatment for categories of patients including those with primary open angle glaucoma. Nadishodhan pranayama and jal neti kriya are two yoga practices which are used by Yoga and Ayurveda therapists for various ailments including primary open angle glaucoma. However, there have been very few studies which examine the effects of yoga practices on primary open angle glaucoma. Also these studies have methodological limitations, therefore present randomized controlled trial is planned to investigate the effects of nadishodhan pranayama and jal neti on patients primary open angle glaucoma.

 
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