| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|