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CTRI Number  CTRI/2024/04/065539 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 25/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of Meditation and Flute Therapy 
Scientific Title of Study   Comparing and analyzing the effects of transcendental meditation and flute music therapy as a stress relieving therapy among ayurveda medical students 
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 Atul Sarokte 
Designation  Associate Professor 
Affiliation  G S Ayurveda Medical Collage & Hospital 
Address  Dept. Of Swasthvritta, room no 12-first Floor, G S Ayurveda Medical collage & Hospital, Pilkhuwa, Hapur-245304

Ghaziabad
UTTAR PRADESH
245304
India 
Phone  08308332530  
Fax    
Email  sarokte.atul@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Atul Sarokte 
Designation  Associate Professor 
Affiliation  G S Ayurveda Medical Collage & Hospital 
Address  Dept. Of Swasthvritta, room no 12-first Floor, G S Ayurveda Medical collage & Hospital, Pilkhuwa, Hapur-245304


UTTAR PRADESH
245304
India 
Phone  08308332530  
Fax    
Email  sarokte.atul@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Atul Sarokte 
Designation  Associate Professor 
Affiliation  G S Ayurveda Medical Collage & Hospital 
Address  Dept. Of Swasthvritta, room no 12-first Floor, G S Ayurveda Medical collage & Hospital, Pilkhuwa, Hapur-245304


UTTAR PRADESH
245304
India 
Phone  08308332530  
Fax    
Email  sarokte.atul@gmail.com  
 
Source of Monetary or Material Support  
CCRAS, Ministry of Ayush, New Delhi, India- 110058 
 
Primary Sponsor  
Name  CCRAS 
Address  Central council for Research in Ayurvedic Sciences New delhi 
Type of Sponsor  Research institution 
 
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 Atul Sarokte  G S Ayurveda Medical Collage, Pilkhuwa  Dept. of Swasthavritta , Room no . 2, Yoga Hall, G S Ayurveda Medical Collage, Pilkhuwa, utter Pradesh-245304
Ghaziabad
UTTAR PRADESH 		 08308332530

sarokte.atul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GS Ayurveda & Medical collage Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F70||Mild intellectual disabilities. Ayurveda Condition: MANA-SANTAPAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: NIL, Ritucarya: NIl, Acara Rasayana:NIl, Other:Transcendental meditation and flute music therapy daily 10 mints each therapy for duration of one month, Pathya/Apathya:no, Pathya:, Apathya:
2Comparator ArmLifestyle--Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:Flute music therapy daily 20 mints for duration of one month, Pathya/Apathya:no, Pathya:, Apathya:
3Comparator ArmLifestyle--Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:Transcendental meditation therapy daily 20 mints for duration of one month, Pathya/Apathya:no, Pathya:, Apathya:
4Comparator ArmLifestyle--Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:Daily Routine lifestyle, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  1) Age: 18-24 years.
2) Both male and female students.
3) scores ranging from 0-13 would be considered low stress.
4) scores ranging from 14-26 would be considered moderate stress.

 
 
ExclusionCriteria 
Details 
1) Menstrual stress
2) scores ranging from 27-40 would be considered high perceived stress.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the effects of Transcendental meditation and flute music therapy among the ayurveda medical students by assessment of Perceived Stress Scale (PSS).  Baseline & on 30th Day 
 
Secondary Outcome  
Outcome  TimePoints 
To anlyse the effects of Transcendental meditation among the ayurveda medical students by assessment of Perceived Stress Scale (PSS).  Baseline & on 30th Day 
To anlyze the effects of flute music therapy among the ayurveda medical students by assessment of Perceived Stress Scale (PSS).  Baseline & on 30th Day 
To assess the change in Perceived Stress Scale (PSS) by compare the group 4 (without any Intervention) & group 2 (flute music therapy) .  Baseline & on 30th Day 
To assess the change in Perceived Stress Scale (PSS) by compare the group 4 (without any Intervention) & group 1 (Transcendental meditation therapy)   Baseline & on 30th Day 
To assess the change in Perceived Stress Scale (PSS) by compare the group 4 (without any Intervention) & group 3 ( Intervention as ranscendental meditation and flute music therapy)   Baseline and on 30th Day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   16/04/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Medical studies bring many stressful conditions to students. Prolonged stress can make adverse affects to mental health and can lead to further professional burnout. According to some studies majority of medical students ( nearly 50% to 70%)perceive stress. [1,2,3] This stress can be managed through various methods. one such method is transcendental meditation.In transcendental meditation technique one have to silently repeat a Mantra in their head until they reach a state of inner peace. The main purpose is to settle your body down to a state of restful alertness. [4,5,6] Music therapy is also used to manage stress and it have great impact on mind and its functions. One such therapy can be taken from flute music.

According to Srimad Bhagavatam part 10 chapter 21, it states that flute music  enhance mood makes positive impact on mind and body. In shloka 14 chapter 21 part 10 of Shrimad Bhagavatam it is also stated that flute music helps in enhancing concentration.According to few studies flute music also enhances serum dopamine levels.[7]Thus flute music can be used to reduce stress and enhance positive thinking and concentration. Flute music along with transcendental meditation can have a great impact on the mind and body and can help to fight the stressful conditions in medical students.

 
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