| CTRI Number |
CTRI/2024/11/076747 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Yoga] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga for young minds: Reducing Anxiety and improving health |
|
Scientific Title of Study
|
The impact of yogic practices on anxiety scores, autonomic functions and lipid profile in young students: A randomized control 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 |
Jagruti Katiyar |
| Designation |
Junior Resident |
| Affiliation |
G.S.V.M Medical College, Kanpur |
| Address |
Department of physiology
G.S.V.M Medical College, Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7007507437 |
| Fax |
|
| Email |
katiyarjagruti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDolly Rastogi |
| Designation |
Head of department |
| Affiliation |
G.S.V.M Medical College, Kanpur |
| Address |
Department of Physiology
G.S.V.M Medical College, Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8400331162 |
| Fax |
|
| Email |
drdollyrastogi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dolly Rastogi |
| Designation |
Head of Department |
| Affiliation |
G.S.V.M Medical College, Kanpur |
| Address |
Department of Physiology
G.S.V.M Medical College, Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8400331162 |
| Fax |
|
| Email |
drdollyrastogi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiology, G.S.V.M. Medical College, Kanpur
PIN 208002
Country: India |
|
|
Primary Sponsor
|
| Name |
Jagruti Katiyar |
| Address |
Department of Physiology
G.S.V.M Medical College, Kanpur, India, Uttar Pradesh
PIN 208002
PIN 208002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Jagruti katiyar |
G.S.V.M Medical college, Kanpur |
Hematology Lab, Room No 1, Department of Physiology, G.S.V.M Medical college, Kanpur
Kanpur Nagar
UTTAR PRADESH |
7007507437
katiyarjagruti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College, Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers suggestive of no present or past illness. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention. |
No intervention |
| Intervention |
Yoga |
Perform Yoga for 30 minutes, 5 days a week for 12 weeks.
Yogasans included are:
1.Pranayam 1 minute.
2.Kapalbhati 1 minute.
3.Suryanamaskar 2 repetitions.
4.Triyaka tadasan 5 repetitions.
5.Naukasan 5 repetitions.
6.Setu bandha sarvangasan 5 repetitions.
7.Titli asan 100 repetitions.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers |
|
| ExclusionCriteria |
| Details |
Subjects less than 18 and more than 25 years.
Exposure to any physical training
History of any illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Significant reduction in anxiety score
2 Improvement in autonomic functions
3 Favorable changes in lipid profile |
1) Baseline
2) 6 weeks
3) 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To study the effect of yoga on the anxiety score
2 To study the effect of yoga on autonomic functions
3 To study the effect of yoga on lipid profile. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="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
|
This study will be conducted to study the impact of yogic practices on anxiety score, autonomic functions and lipid profile in young students. It can be interpreted that yoga intervention has a significant improvement on anxiety score, autonomic functions and lipid profile in young students. |