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CTRI Number  CTRI/2025/11/097767 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of yoga and mudras on college students 
Scientific Title of Study   Comparative Effects of a tailored Yoga protocol with and without mudras on selected physiological and psychological parameters of college students 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 Sunita Sahish 
Designation  Associate Professor 
Affiliation  Sant hirdaram medical college of naturopathy and yogic sciences for women bhopal 
Address  Room No BS 29, Second floor, Department of Yoga, Sant Hirdaram medical college of naturopathy and yogic sciences for women bhopal

Bhopal
MADHYA PRADESH
462030
India 
Phone  7610348613  
Fax    
Email  sunitasahish9493@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyoti keswani 
Designation  Professor 
Affiliation  Sant hirdaram medical college of naturopathy and yogic sciences for women bhopal 
Address  Room No BS 29, Second floor, Department of Yoga, Sant Hirdaram medical college of naturopathy and yogic sciences for women bhopal

Bhopal
MADHYA PRADESH
462030
India 
Phone  9893782683  
Fax    
Email  jyoti.r.keswani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyoti keswani 
Designation  Professor 
Affiliation  Sant hirdaram medical college of naturopathy and yogic sciences for women bhopal 
Address  Room No BS 29, Second floor, Department of Yoga, Sant Hirdaram medical college of naturopathy and yogic sciences for women bhopal


MADHYA PRADESH
462030
India 
Phone  9893782683  
Fax    
Email  jyoti.r.keswani@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Sant Hirdaram medical college of naturopathy and yogic sciences for women bhopal 
Address  Sant Hirdaram medical college of naturopathy and yogic sciences for women bhopal, lake road, Sant Hirdaram nagar, bhopal- 462030. 
Type of Sponsor  Private 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 Sunita Sahish  Sant hirdaram medical college of naturopathy and yogic sciences for women bhopal.   Room No BS 29, Second floor, Department of Yoga, Sant Hirdaram medical college of naturopathy and yogic sciences for women bhopal
Bhopal
MADHYA PRADESH 
7610348613

sunitasahish9493@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee sant hirdaram medical college of naturopathy and yogic sciences for women bhopal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Physically and Mentally Fit 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  A prospective interventional non-blinded two-arm randomized parallel group   The present study is a randomized Controlled trial. The Comparator agent will be or Yoga with mudras group who will receive 60 minutes of tailored Yoga practices along with selected mudras for a period of 3 months, 6 days a week (Except Sundays and College holidays).  
Intervention  Tailored Yoga Practices   After obtaining informed consent and completing baseline examination, investigations and questionnaires, students will be randomly allocated to Yoga only group. They will be exposed to the Yoga intervention or tailored Yoga Protocol of 45 minutes duration for a period of 3 months, 6 days a week (Except Sundays and College holidays). At the end of the three-month intervention period, the students will be subjected to the examination, investigations and questionnaires again. Only complete data will be analysed using appropriate statistical procedures.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  Participants between ages 18 to 25 years
Participants who provide a written consent.
Participants do not have any serious problems with physical and psychological health.
Participants do not have any prior experience with Yoga and/or not engaged in intensive physical exercises such as gym activities for at least last 3 months.
 
 
ExclusionCriteria 
Details  Participants below 18 to above 25 years of age.
Participants who do not provide a written consent.
Participants with serious problems with physical and psychological health.
Participants with prior experience with Yoga and/or intensive physical exercises such as gym activities for at least last 3 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the changes in physical and psychological health parameters.
To assess the changes in Lifestyle related parameters
 
Baseline (Day 0) and Post-Intervention (after 3 months) 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the changes in Flexibility and Hand Grip.
To assess changes in Body Mass Index and Waist-Hip Ratio
To assess general and organ health such as Heart and Lungs.
To assess changes in blood cell counts (CBC)
To assess changes in visual acuity.
To assess changes in menstrual cycle and quality of sleep.
To assess changes in reaction time, concentration, and memory.
To assess state of psychological symptoms such as stress, anxiety and depression.
 
3 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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/ Phase 3 
Date of First Enrollment (India)   01/12/2025 
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="0"
Months="3"
Days="0" 
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 - NO
Brief Summary  

The present study is a randomized Controlled trial. After receiving ethical approval and procuring CTRI registration, the study is proposed to be commenced in the month of December 2025. 85 students of BNYS first year fresher who give written consent will be screened to constitute a final sample size of 70.  They will be recruited in the study in either intervention arm or active arm through a computerized randomization using alternation method. Participants meeting the inclusion criteria will be informed about the study’s objectives, voluntary nature, confidentiality, and right to withdraw at any point during the study. After providing informed consent and completing baseline examination, investigations and questionnaires, students will be randomly allocated to Yoga only group and Yoga with mudra group. They will be exposed to their respective Yoga intervention (tailored Yoga Protocol of 45 minutes duration and tailored Yoga protocol with mudras of 60 minutes duration) for a period of 3 months, 6 days a week (Except Sundays and College holidays). At the end of the three-month intervention period, the students will be subjected to the examination, investigations and questionnaires again. Only complete data will be analysed using appropriate statistical procedures.

 
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