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CTRI Number  CTRI/2024/10/074695 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Immediate effect of DRT(Deep Relaxation Technique) 
Scientific Title of Study   Immediate effect of Deep Relaxation Technique (DRT) on Heart Rate Variability among Healthy individuals – A Randomized controlled trial 
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 S Harishma 
Designation  PG Scholar 
Affiliation  nternational Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu 
Address  184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First Floor), Department of Yoga, Kamarajar Nagar, Chengalpattu. Kancheepuram TAMIL NADU

Kancheepuram
TAMIL NADU
603001
India 
Phone  9751143555  
Fax    
Email  harishmakrishnan16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr A GayathrI 
Designation  Head Of Department I/C (Yoga) 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu 
Address  184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First Floor), Department of Yoga, Kamarajar Nagar, Chengalpattu. Kancheepuram TAMIL NADU

Kancheepuram
TAMIL NADU
603001
India 
Phone  8124634017  
Fax    
Email  gayathriannamalai93@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr A GayathrI 
Designation  Head Of Department I/C (Yoga) 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu 
Address  184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First Floor), Department of Yoga, Kamarajar Nagar, Chengalpattu. Kancheepuram TAMIL NADU


TAMIL NADU
603001
India 
Phone  8124634017  
Fax    
Email  gayathriannamalai93@gmail.com  
 
Source of Monetary or Material Support  
International Institute of Yoga and Naturopathy Medical College hospital, Chengalpattu, Tamilnadu -603001 
 
Primary Sponsor  
Name  Dr S Harishma 
Address  184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First Floor), Department of Yoga, Kamarajar Nagar, Chengalpattu. Kancheepuram TAMIL NADU 
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 SHarishma  International Institute of Yoga and Naturopathy Medical hospital   184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First Floor), Department of Yoga, Kamarajar Nagar, Chengalpattu. Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU 
09751143555

harishmakrishnan16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nil 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  rest in sitting position   No intervention for comparative group.Patients have to rest sitting for duration 20 minutes 
Intervention  Deep Relaxation Technique  Patients have to perform Deep Relaxation Technique (DRT) for duration of 20 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Patient should be underage of 18- 35 years. Both male and female healthy participants who are willing to give their consent 
 
ExclusionCriteria 
Details  Participants with spinal injuries, psychiatric illness, systemic illness, surgical history, Congenital comorbidities, Pregnancy and mensuration.
Regular Yoga practicing induvial are exclude from this study  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
HRV is the beat-to-beat variation of the cardiac cycle that represents sympathovagal
balance. The lead II ECG will be recorded using the Analogue ECG amplifier with A to
D (Analogue to Digital) conversion using the sound card inside the computer. The data
was analyzed using KUBIOS 1.1 software, Finland, which is used to measure the
different variables such as the time or frequency domain. Time-domain analysis is
calculated directly from the raw RR interval. The frequency domain shows the variability
of the RR signal over time by looking at the proportion of the wavelengths relative to the
original RR- signal. 
Immediately before and after the procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Diastolic & systolic blood pressures  Immediately before & after the practice of DRT 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 2 
Date of First Enrollment (India)   23/10/2025 
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="1"
Months="1"
Days="1" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 12-08-2025 and end date provided 16-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nothing
Brief Summary  

Deep Relaxation Technique (DRT) which is a form of Yogic Relaxation Technique developed at Swami Vivekananda Yoga Anusadhana Samsthan, Bengaluru was given for 20 minutes as an intervention. It is a systematic method of developing inner awareness. It emphasizes part-by-part relaxation of the whole body. It works at all levels of the existence of an individual at physical, mental, emotional, intellectual, and spiritual levels. It involves the relaxation of all body parts by directing the attention of the mind on different parts of the body starting from the toes to end up in the head region to propagate the relaxation feeling. DRT is known to reduce the state of anxiety and to improve sustained attention, also helps to improve sleep quality.  The practice of relaxation techniques has been shown to modify the autonomic response to mental stress which is generally termed as relaxation response, that tends to restore the altered sympatho-vagal balance towards normal. Probable 3 physiological mechanisms in meditation would be sensory attenuation, motor attenuation, and nonanalytical thinking, evoking minimal cortical activity. Heart rate variability (HRV) measures the beat-to-beat changes in heart rate and provides information on how the parasympathetic and sympathetic nervous systems control the cardiovascular system. Through the sinoatrial (SA) node, increased sympathetic nervous system activity raises heart rate, whereas increased parasympathetic nervous system (vagus nerve) activity lowers heart rate. Though the multifaceted physiological and psychological health benefits of both short- and long-term yoga training are quite well established, only very few studies have reported on the immediate effects of a single session.

 
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