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CTRI Number  CTRI/2025/04/084255 [Registered on: 07/04/2025] Trial Registered Prospectively
Last Modified On: 01/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Role of yoga intervention in Glaucoma 
Scientific Title of Study   Impact of Yoga and Meditation on mitochondrial health, Telomere length and differentially expressed miRNA in POAG 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr MANOJ KUMAR 
Designation  Scientist-II 
Affiliation  AIIMS, New Delhi 
Address  Department of Anatomy, Teaching Block, AIIMS, New Delhi.

South
DELHI
110029
India 
Phone  9711887047  
Fax    
Email  mkachlas@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr MANOJ KUMAR 
Designation  Scientist-II 
Affiliation  AIIMS, New Delhi 
Address  Department of Anatomy, Teaching Block, AIIMS, New Delhi.


DELHI
110029
India 
Phone  9711887047  
Fax    
Email  mkachlas@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Dr MANOJ KUMAR 
Designation  Scientist-II 
Affiliation  AIIMS, New Delhi 
Address  Department of Anatomy, Teaching Block, AIIMS, New Delhi.


DELHI
110029
India 
Phone  9711887047  
Fax    
Email  mkachlas@aiims.edu  
 
Source of Monetary or Material Support  
Room No 1027A, Department of Anatomy, AIIMS, New Delhi-110029, India. 
 
Primary Sponsor  
Name  AIIMS NEW DELHI 
Address  Room No 1027A, Department of Anatomy, AIIMS, New Delhi-110029, India. 
Type of Sponsor  Research institution and hospital 
 
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 MANOJ KUMAR  AIIMS, NEW DELHI  Room No 1027A, Department of Anatomy, AIIMS, New Delhi-110029, India.
South
DELHI 		 01126596716

mkachlas@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H402||Primary angle-closure glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Routine day today physical and mental activity  Activities of daily living does not include yoga or consumption of any special herbal nutritive or medications. 
Intervention  YOGA  Yoga based lifestyle intervention program developed at Integral Health clinic comprises Asanas(physical postures), Pranayama (breathing exercise), Dhayna (Meditation) and counselling and education on healthy lifestyle. The intervention is 21 days combined Yoga and Meditation programme conducted on daily basis at Department of Anatomy, All India Institute of Medical Sciences, New Delhi. The course consists of mindfulness-based meditation, various relaxation and breathing techniques taught by designated meditation trainers who are qualified and certified professionals. Each session will be approximately 30 min duration (15minutes breathing exercises followed by 15 minutes mindfulness meditation).  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients with moderate to advanced primary open angle glaucoma who are planned for trabeculectomy.
Age more than 40 years
Uncontrolled IOP on maximum topical medications
Willful to attend full course of intervention.
Conversant in Hindi and/or English 
 
ExclusionCriteria 
Details  Refusal to participate in study.
Patients with other types of glaucoma.
Systemic co-morbidities (Depression, diabetes, coronary artery disease, cerebrovascular
disease etc.).
Any co morbid ocular condition (corneal opacity, retinal pathologies, optic neuropathy other
than glaucoma).
History of ocular surgery within past 6 months
Patients on medical therapy for other diseases
Subnormal mentation and patients with communication difficulties
Already practicing Yoga and meditation in any form.
Age less than 40 years 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in IOP  Baseline, Day=21 or 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in Oxidative stress
Increase in Telomere length
Improved Mitochondrial Health & Integrity
Normalized expression of the miRNA 		 2 years and 6
months 
 
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   N/A 
Date of First Enrollment (India)   15/05/2025 
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="2"
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  
We have planned this study to see the effect of yoga as a lifestyle intervention in POAG patients. Patients will undergo a structured and pre-tested yoga program. The supervised yoga-based intervention (including gentle physical movements and postures (asanas), breathing techniques (pranayamas), meditation, and lectures on yoga philosophy) is a regular outpatient-based program, practiced for two hours each day for the 21 days. Following the yoga intervention the patients will become less anxious with better coping mechanism. This study will also enlighten the effect of yoga on biomarkers of inflammation and oxidative stress in POAG and to further understand the pathogenesis of the disease. Thus, it may be possible to use it as an adjunct therapy.
 
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