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Clinical Trial Details (PDF Generation Date :- Fri, 05 Aug 2022 01:25:15 GMT)

CTRI Number CTRI/2022/07/044042 [Registered on: 15/07/2022] - Trial Registered Prospectively


Last Modified On 12/07/2022
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 Effect of Jal Neti and Nadi Shodhan Pranayama (Anuloma-viloma Pranayama) on the clinical
Study parameters of patients with primary open angle glaucoma (POAG)
Secondary IDs if Any Secondary ID Identifier
NIL NIL
Details of Principal Details of Principal Investigator
Investigator or overall
Name Jayvindra Singh
Trial Coordinator
(multi-center study) 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 Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Dr VK Katiyar
Query)
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 Contact Details Contact Person (Public Query)
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

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PDF of Trial
CTRI Website URL - http://ctri.nic.in

Source of Monetary or Source of Monetary or Material Support


Material Support
> University of Patanjali, Haridwar
Primary Sponsor Primary Sponsor Details
Name University of Ptatanjali
Address University of Patanjali, Patanjali Yogpeeth, Haridwar, Uttarakhand
Type of Sponsor Other [University]
Details of Secondary Name Address
Sponsor
Nil Nil
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Jayvindra Singh University of Patanjali Department of Yoga 9536011319
Science, University of
Patanjali, Patanjali jayrana319@gmail.com
Yogpeeth, Haridwar
Hardwar
UTTARANCHAL
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Institutional Ethical Approved 15/06/2022 No
Committee, University
of Patanjali
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Patients Open-angle glaucoma
Intervention / Type Name Details
Comparator Agent
Intervention Anuloma viloma pranayama, Anuloma viloma pranayama and
jala neti 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 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<br/> (ii) Patients
diagnosed with primary open angle glaucoma and currently on eye
drop medication<br/> (iii) Persons willing to take part in the study
Exclusion Criteria Exclusion Criteria
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 Computer generated randomization
Random Sequence
Method of Not Applicable

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PDF of Trial
CTRI Website URL - http://ctri.nic.in

Concealment
Blinding/Masking Outcome Assessor Blinded
Primary Outcome Outcome Timepoints
(i) Intra ocular pressure Baseline
(ii) Visual fields
(iii) Optical coherence tomography
(iv) Visual acuity test
Secondary Outcome Outcome Timepoints
(i) Intra ocular test 3 months
(ii)Visual field
(iii) Optical coherence tomography
(iv) Visual acuity test
Target Sample Size Total Sample Size=30
Sample Size from India=30
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 2
Date of First 18/07/2022
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=6
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Not Yet Recruiting
Trial (India)
Publication Details NIL
Brief Summary 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 ?-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

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PDF of Trial
CTRI Website URL - http://ctri.nic.in

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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