| CTRI Number |
CTRI/2024/11/076914 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the Impact of Pranayama and Cyclic Meditation on Stress Management in Adolescents: A Therapeutic Study |
|
Scientific Title of Study
|
Effect of Pranayama and Cyclic Meditation in the management of Stress in Adolescents: Therapeutic 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 |
Komal Purushuttom Wasnik |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurveda Mahavidyala Nagpur |
| Address |
Shri Ayurveda Mahavidyalaya Nagpur, Department of Swasthyavritta and Yoga, 1st Floor.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9921992407 |
| Fax |
|
| Email |
komalwasnik2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Archana Raman Belge |
| Designation |
HOD Swasthavritta and Yoga |
| Affiliation |
Shri Ayurveda Mahavidyala Nagpur |
| Address |
Department of Swasthavritta and Yoga, 1st Floor,
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9921992407 |
| Fax |
|
| Email |
archanabelge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Komal Purushuttom Wasnik |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurveda Mahavidyala Nagpur |
| Address |
Department of Swasthavritta and Yoga, 1st floor
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9921992407 |
| Fax |
|
| Email |
komalwasnik2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ayurveda Mahavidyalaya, Hanuman Nagar,Dhanvanatari Road, Nagpur, Maharashtra, India 440024 |
|
|
Primary Sponsor
|
| Name |
Komal Wasnik |
| Address |
Shri Ayurveda Mahavidyalaya, Hanuman Nagar,Dhanvanatari Road, Nagpur, Maharashtra, India 440024 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Komal Wasnik |
Shri Ayurveda Mahavidyalaya, |
Department of Swasthavritta and Yoga, 1st floor
Nagpur
MAHARASHTRA |
9921992407
komalwasnik2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
13 to 19 age group adolescents |
|
| ExclusionCriteria |
| Details |
1.Any Systemic Diseases CVS, RS.
2. Psychiatric disorders.
3.History of fracture up to 3 months and newly operated cases of abdominal surgery like hernia. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expected outcome of the study is that whether Pranayama and Cyclic Meditation will effectively reduce stress level among adolescents.
The results are likely to show improved stress management, relaxation, mindfulness, and physiological indicators of relaxation in both groups.
This study likely to show increase positive attitude in adolescents and increase concentration level in their studies. |
0 baseline, 10th day,20th Day, 30th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
12/12/2024 |
| 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="6"
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
|
Study Design Summary
Objective: The study aims to evaluate the effects of Pranayama and Cyclic Meditation on stress reduction in adolescents.
--- Trial Group - Group A (Pranayama) - No. of Patients: 20 - Treatment: Nadi Shodhan Pranayama (3 min), Bhastrika Pranayama (3 min), Bhramari Pranayama (3 min) with 1-minute relaxation after each type of pranayama. - Time: Morning hours (6-8 am) - Duration of Procedure: 12 minutes - Course Duration: 1 month - Follow-up: 0th, 10th, 20th, and 30th day
Control Group: - Group B (Cyclic Meditation): - No. of Patients: 20 - Treatment: Cyclic Meditation - Time: Morning hours (6-8 am) - Duration of Procedure: 22 minutes - Course Duration: 1 month - Follow-up: 0th, 10th, 20th, and 30th day
Both groups undergo the same follow-up schedule to assess the impact of their respective treatments on stress levels over the 1-month course. |