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CTRI Number  CTRI/2024/09/074390 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 15/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of Ishavasyopanishad Mantra Pathan (recitation) 
Scientific Title of Study   A randomized control trial to study the effects of the Ishavasyopanishad Mantra Pathan (recitation) on human physiological parameters. 
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 Vishwanath Pandurang Kale 
Designation  Research Head 
Affiliation  Yog Vidya Dham, Ahmednagar 
Address  Research Department, Yog Vidya Dham, Chintamani Colony, Near Dnyaneshwar Motor Driving School, Bhistbag Road, Savedi, Ahmednagar. PIN 414003

Ahmadnagar
MAHARASHTRA
414003
India 
Phone  09372454022  
Fax    
Email  dr.kalevp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vishwanath Pandurang Kale 
Designation  Research Head 
Affiliation  Yog Vidya Dham, Ahmednagar 
Address  Research Department, Yoga Vidya Dham, Chintamani colony, near Dnyaneshwar motor driving school, Bhistbag road, Savedi, Ahmednagar. PIN 414003

Ahmadnagar
MAHARASHTRA
414003
India 
Phone  07756004500  
Fax    
Email  yvdahmednagar.sanshodhan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mrs Pramila Amar Agarwal 
Designation  Research Asistant 
Affiliation  Yog Vidya Dham, Ahmednagar 
Address  Reasearch Department, Yoga Vidya Dham, Chintamani colony, near Dnyaneshwar motor driving school, Bhistbag road, Savedi, Ahmednagar. PIN 414003

Ahmadnagar
MAHARASHTRA
414003
India 
Phone  9145134656  
Fax    
Email  pramilaagarwal81@gmail.com  
 
Source of Monetary or Material Support  
Haritakri Hospital, 104 A, Aaradhya Avenue, near Ekvira Chawk, Pipeline road, Savedi Ahmednagar. PIN 414003 (within a km from above site only for medical tests) 
Yoga Vidya Dham, Chintamani colony, near Dnyaneshwar motor driving school, Bhistbag road, Savedi, Ahmednagar. PIN 414003  
 
Primary Sponsor  
Name  Yog Vidya Dham Ahmednagar 
Address  Yoga Vidya Dham, Chintamani colony, near Dnyaneshwar motor driving school, Bhistbag road, Savedi, Ahmednagar. PIN 414003  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mr Baban Hari Bargal  Haritakri Hospital  104a, Aradhya Avenue, Ekvira Chak, Savedi, Pipeline Road, Ahmednagar PIN 414003
Ahmadnagar
MAHARASHTRA 		 9420634588

babanbargal9@gmail.com 
Mr Dattatray Mallaya Dikonda  Yog Vidya Dham  Yoga Vidya Dham, Chintamani colony, near Dnyaneshwar motor driving school, Bhistbag road, Savedi, Ahmednagar. PIN 414003
Ahmadnagar
MAHARASHTRA 		 9130514793

dattajiom@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vikhe Patil Institute of Medical Sciences (VIMS) Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ishavasyopnishad Mantra Pathan (recitation)  Ishavasyopanishad text pathan (18 Mantra) 11 avartan (repetitions) tri Sandhya (thrice) per day for 4 weeks. They are told not to follow any other Pathan except above during experiment period. 
Comparator Agent  Not providing Pathan of Ishavasyopnishad Mantra Pathan  The control group persons will neither be taught nor practiced the Ishavasyopnishad Mantra Pathan. They are also not allowed to follow any other Pathan too. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Those who are willing to follow the Pathan protocol and ready not to seek any stress treatment while involved as a participant in this project.
2. The participants in the age group 18 to 80 years, (male and female) will be allowed.
3. Those who are not involved in any other such activity simultaneously will be allowed.
4. As far as possible the subjects will be divided into two groups having the similar structure.
 
 
ExclusionCriteria 
Details  1. Those who are diagnosed with serious mental and physical health issues, having serious stress, under medical treatment for it, and having other medical problems.
2. Those who are being practicing other form of Pathan.
3. Those who are not agree with teaching protocol and consent after explaining the aim and design of the study for any reason.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. The appropriate Pathan of Ishavasyopanishad to relieve the stress parameters in human individuals.
 		 On the first day before starting the trial and on the last day after completing the trial (1 month) 
 
Secondary Outcome  
Outcome  TimePoints 
1. The relations observed between the interventional parameters in modern clinical tests.  On the first day before starting the trial and on the last day after completing the trial (1 month) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
In daily life, we face a myriad of challenges, both personal and societal, such as stress, the rapid evolution of technology, and diseases linked to our lifestyles. The mantras from the Upanishads have long been considered a precious gift to humanity. These mantras, which conclude the Vedas, are traditionally recited systematically under the guidance of a knowledgeable teacher, or Guru, a practice known as ’Pathan’. Our research aims to explore the physiological impacts of chanting the Ishavasyopanishad Mantra on individuals.
During our literature review, we analyzed an article in the Odisha Review (ISSN 0970-8669) by Professor Santosh Kumar Nayak, a study on chakra frequency related to earth and brainwaves by Dr. Jay Paul Dudeja (3.21.10.22413/ijastems/2017/v3/i6/49101), and research by Kuppusamy (13.CC05-CC09.10.7860/JCDR/2019/41236.1277). We also reviewed a meta-analysis by MPDI among other studies, but noted gaps in establishing objective connections. As a result, we structured a study with a scientific approach to provide definitive evidence.
We designed a two-group study with 20 subjects in each group (control and experimental), selected through random sampling. In this single-blind study, after providing the Participant Information Sheet (PIS) to respondents and obtaining their consent, we used the semi-SIAM notation method (annexure 1) on observation sheets to conceal identities. Participants will be introduced to the Pathan method by a learned guru, followed by a sufficient interval to mitigate the effects of learning on the research parameters before conducting the pre-test. The PSS-14, HSS-1 scales, Heart Rate Variability (HRV), and serum cortisol levels are the parameters to be examined in this study. The intervention will follow the schedule outlined in Annexure, and post-tests will be administered accordingly.
The gathered data will be processed following the standard protocol detailed in the annexure, utilizing statistical tools and techniques such as the student’s t-test, and if necessary, with intervention.
 
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