| CTRI Number |
CTRI/2024/12/078729 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of 365 Breathing technique as an adjunctive modality to improve outcomes in Primary Open Angle Glaucoma patients. |
|
Scientific Title of Study
|
A Study to Analyse the Effect of 365 Breathing Technique as an Adjunctive Modality along with Standard Medical Management on Intraocular pressure, Serum Cortisol and Optic nerve Head perfusion in Patients with Primary Open Angle Glaucoma. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonal Kalia |
| Designation |
Associate Professor |
| Affiliation |
SMS Medical College JAIPUR |
| Address |
Upgraded Department of Ophthalmology, Charak Bhawan, SMS Medical College and Hospital,JLN Marg
Jaipur
RAJASTHAN
302004
India |
| Phone |
9571721727 |
| Fax |
|
| Email |
dr_sonal21@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Kalia |
| Designation |
Associate Professor |
| Affiliation |
SMS Medical College JAIPUR |
| Address |
Upgraded Department of Ophthalmology, Charak Bhawan, SMS Medical College and Hospital,JLN Marg
Jaipur
RAJASTHAN
302004
India |
| Phone |
9571721727 |
| Fax |
|
| Email |
dr_sonal21@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Kalia |
| Designation |
Associate Professor |
| Affiliation |
SMS Medical College JAIPUR |
| Address |
Upgraded Department of Ophthalmology, Charak Bhawan, SMS Medical College and Hospital,JLN Marg
Jaipur
RAJASTHAN
302004
India |
| Phone |
9571721727 |
| Fax |
|
| Email |
dr_sonal21@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SMS Medical college and Hospital, Charak Bhawan ,JLN Marg, Jaipur, Rajasthan, India. Pin code -302004 |
|
|
Primary Sponsor
|
| Name |
Upgraded Department of Ophthalmology SMS Medical College and Hospital |
| Address |
SMS Medical College and Hospital, Charak Bhawan, JLN Marg, Jaipur, Rajasthan, India (302004). |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anusuya |
SMS Medical College &Hospital, Jaipur |
Upgraded Department of Ophthalmology, Unit 3, Glaucoma clinic, room no.C22,Charak Bhawan, JLN Marg, Jaipur
Jaipur
RAJASTHAN |
9729491335
anusuyanahar08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF ETHICS COMMITEE,S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITALS,JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A Study to Analyse the Effect of 365 Breathing Technique as an Adjunctive Modality along with Standard Medical Management on Intraocular pressure, Serum Cortisol and Optic nerve Head perfusion in Patients with Primary Open Angle Glaucoma. |
Out of total sampled size of 70, 35 patients fulfilling inclusion criteria will be kept as Group A and will be kept only on pharmacological antiglaucoma treatment and will be waitlisted for same intervention and 35 patients will be included in Group B who will be performing 365 breathing technique along with their pharmacological antiglaucoma treatment. Patients will be taught “365 breathing technique†along with their anti glaucoma medications at glaucoma clinic. Follow up visits will be done at 6 weeks and 16 weeks after enrolment. It will include measurement of IOP ,Serum cortisol and Optic nerve head perfusion..
This is followed by assessing changes in IOP, Serum cortisol and Optic nerve head perfusion by investigator and comparing results between two groups.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Early to moderate Primary open angle glaucoma (as per Hodapp Parish Anderson classification) : newly diagnosed & started on medication that is Treatment naïve POAG patients and POAG patients previously on topical antiglaucoma medications.
2.Age: 40-80 years
3.Willing to consent with regular follow up and perform 365 breathing.
4.Geographical proximity : Preferably District Jaipur (rural & urban ).
|
|
| ExclusionCriteria |
| Details |
1. Ocular morbidities other than glaucoma contributing to visual loss ( ocular trauma, angle closure glaucoma , Retinal diseases ).
2. Any ocular surgery in previous three months.
3. Deaf/ Communication impaired/Subnormal mentation.
4 . Already practicing Yoga/Meditation in any form since long time.
5. Chronic systemic diseases significantly affecting quality of life like Malignancy, Respiratory disease, Thyroid disease ,coronary artery disease, Hypertension , Diabetes mellitus, rheumatoid arthritis & autoimmune diseases& chronic allergies .
 6. On any long term drugs known to affect autonomic functions like anticholinergics including antidepressants, Antihistamines, Diuretics, sympathomimetic and parasympathomimetic agents.
7. Geographically very far ( outside Jaipur ) and unable to come for regular follow up. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Intraocular Pressure in two groups of patients(A and B). |
At 6 weeks and 16 weeks after enrolment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Optic nerve head perfusion and Serum Cortisol in two groups of patients (A and B). |
At 16 weeks after enrolment. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2025 |
| 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="1"
Months="6"
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
|
Glaucoma is one of the leading causes of irreversible blindness in the world. IOP remains the only modifiable risk factor. Many other mechanisms are known to contribute to glaucomatous nerve damage. Many studies have shown a positive correlation between physiological stress and glaucoma. A growing number of studies have shown that breathing techniques are effective in reducing stress by influencing both psychological factors by diverting attention from negative thoughts and physiological factors by stimulating parasympathetic nervous system.AIM of our trial is to study the effect of “365 breathing technique†as an adjunct to standard medical management on Intraocular pressure, Optic nerve head perfusion and Serum cortisol in patients with Primary Open Angle Glaucoma: a Randomized study. In this randomized controlled trial,35 patients fulfilling inclusion criteria will be kept as Group A and will be kept only on pharmacological antiglaucoma treatment and will be waitlisted for same intervention and 35 patients will be included in Group B who will be performing 365 breathing technique along with their pharmacological antiglaucoma treatment. Planned sample size-70 (Group A -35 and Group B- 35). |