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CTRI Number  CTRI/2023/10/058325 [Registered on: 05/10/2023] Trial Registered Prospectively
Last Modified On: 30/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of yogasana and pranayama in elderly people health 
Scientific Title of Study   A clinical study to evaluate the efficacy of yogasana and pranayama in geriatric healthcare 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RITURA SHARMA 
Designation  MD SCHOLAR 
Affiliation  Post graduate institute of Ayurved 
Address  Post graduate institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9461243224  
Fax    
Email  drriturasharma28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR PRAMOD KUMAR MISHRA 
Designation  PROFESSOR AND HOD 
Affiliation  Post graduate institute of Ayurved 
Address  Post graduate institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9001009793  
Fax    
Email  drpramodmishra4@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PRAMOD KUMAR MISHRA 
Designation  PROFESSOR AND HOD 
Affiliation  Post graduate institute of Ayurved 
Address  Post graduate institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9001009793  
Fax    
Email  drpramodmishra4@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of ayurved dr Sarvepalli Radhakrishnan ayurved university karwad jodhpur rajasthan 
 
Primary Sponsor  
Name  Post Graduate Institute of ayurved 
Address  P G Department of Swasthvritta and yoga Post Graduate Institute of ayurved 
Type of Sponsor  Government medical college 
 
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 Ritura  Post Graduate Institute of Ayurved  Department of Swasthvritta and yoga OPD no 8 Post Graduate Institute of Ayurved
Jodhpur
RAJASTHAN 		 9461243224

drriturasharma28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Post Graduate Institute of Ayurved Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R54||Age-related physical debility, (2) ICD-10 Condition: R54||Age-related physical debility,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: yoga, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Elderly persons aged between 60 to 75 years irrespective of their caste, race and sex etc.
Wiling to participate 
 
ExclusionCriteria 
Details  Elderly persons age below 60 and above 75 years.
• Physical disability, severe pain, obstructive disease, osteoarthritis, rheumatoid arthritis, injury or paralysis.
• Severe cognitive disease like Alzheimer’s.
• Extensive surgery the past years or planned the coming year.
• Blood pressure ≥160mm Hg systolic, ≥100mm Hg diastolic (blood pressure will be measured in sitting position twice in each arm) or irregular pulse.
• Contraindication of Yogasana 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Mobility, Sleep Anorexia Indigestion Constipation Weight loss Sensory Perception Lack Of Memory Adjustment To Weather Wrinkle Of Skin Dyspnea Palpitation Chest Pain Joint Pain Sex Desire  Every 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
To Achieve Improvement In Elderly Mobility Scale Score Optimum Body Weight Basal Metabolic Index


 		 Every 30 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Number of patient 40
Type of study - Open label
Intervention - yoga and pranayama
Randomisation - Non Random

Yogasana will be done on empty stomach or after breakfast.
Duration time one hour.
2 times/day 
Name of yogasana in standing position
 1 Tadasana with support
2 Vrikshasana with support
3 Trikonasana
4 Ardhachakrasana
5 Katichakrasana

Yogasana in sitting position.
1 Bhadrasana
2 Vajrasana
3 Paschimotanasan
4 Shashankasana
5 Uttanmandukasana

Yogasana in lying position.
1 Pavanmuktasan
2 Bhujangasana
3 Makarasan
4 Shalbhasan
5 Shavasan

Pranayaam –
1 Anulom Vilom 10 times
2 Om chanting 10 times

 Duration of Study – 3 Months for each patient including follow ups.

Follow up period will be 30 days during study and after 3 months after completion of study.



 
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