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CTRI Number  CTRI/2022/06/043044 [Registered on: 06/06/2022] Trial Registered Prospectively
Last Modified On: 07/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Cyclic Meditation(CM) on women entrepreneurs  
Scientific Title of Study   Effect of Cyclic Meditation (CM) on stress, burnout, and entrepreneurial self-efficacy in women entrepreneurs 
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 Sony Kumari 
Designation  Associate Professor 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana University 
Address  Prashanti Kutiram
Vivekananda Road, Kalluballu Post, Jigani, Anekal
Bangalore
KARNATAKA
560105
India 
Phone  09742060024  
Fax    
Email  sony.karmanidhi@svyasa.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Ranisha K 
Designation  PhD Scholar 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana University 
Address  Prashanti Kutiram
Vivekananda Road, Kalluballu Post, Jigani, Anekal
Bangalore
KARNATAKA
560105
India 
Phone  09539517385  
Fax    
Email  ranishakkannamvayal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ranisha K 
Designation  PhD Scholar 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana University 
Address  Prashanti Kutiram
Vivekananda Road, Kalluballu Post, Jigani, Anekal
Bangalore
KARNATAKA
560105
India 
Phone  09539517385  
Fax    
Email  ranishakkannamvayal@gmail.com  
 
Source of Monetary or Material Support  
Swami Vivekananda Yoga Anusandhana Samsthana University 
 
Primary Sponsor  
Name  Swami Vivekananda Yoga Anusandhana Samsthana  
Address  Swami Vivekananda Rd Kalluballu Post Anekal Jigani Karnataka  
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 
RANISHA K  SVYASA University  Yoga and Management Department, Swami vivekananda Rd, Kalluballu Post ,Anekal ,Jigani ,560105
Bangalore
KARNATAKA 		 09539517385

ranishakkannamvayal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) - SVYASA   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  stress, burnout 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-NILNIL
2Intervention ArmLifestyle--Dinacarya: NA, Ritucarya: NA, Acara Rasayana:NA, Other:Cyclic Meditation (CM) is a yogic relaxation method based on Ancient Indian Wisdom. It is a moving meditation technique combining physical postures (asanas) with relaxation procedures. The intervention is for 4 weeks, 5 days of practice in a week, and each session for 35 minutes every day. , Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  a)Women entrepreneurs doing business in Kerala.
b)Not exposed to yoga practice in the last 1 year.
c)Those who are having stress levels moderate and above (PSS Score >13)
d)Signed consent form
e)literate
 
 
ExclusionCriteria 
Details  a)Under regular medication for any psychological condition or another chronic disease.
b)Missing fingers, or cutting in the finger (10 fingers required for Bio-Well recordings).
c)Pregnant women
d)PSS Score <13 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Perceived stress
2. Burnout
3. Entrepreneurial self-efficacy  		 day 0 (before the start of the trial)
day 30 (after the end of the trial)
day 90 (follow up)  
 
Secondary Outcome  
Outcome  TimePoints 
Effect of Cyclic Meditation (CM) practice on the physiological, emotional, and spiritual health of women entrepreneurs using the GDV Bio-well device.  day 0 (before the start of the trial)
day 30 (after the end of the trial)
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/06/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Women entrepreneurs are facing more challenges than their counterparts and stress, and burnout is important concerns that hinder their health as well as performance. So, the current study intended to examine the effect of moving meditation practice called Cyclic Meditation (CM) on stress, burnout, and entrepreneurial self-efficacy, their correlation, with characteristics of self-actualization through a randomized controlled study. Also, the shreds of evidence from a non-invasive technique called the GDV Bio-well device will increase the strength of evidence by measuring the stress level, psychosomatic health, and psychospiritual health before and after the practice. 
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