| CTRI Number |
CTRI/2024/10/074870 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The Effects of Vipassana Meditation on Middle Aged Tamil Nadu Residents |
|
Scientific Title of Study
|
Exploring the Impact of Vipassana Meditation on Attainment of Yama and Niyama among Middle aged People in Tamil Nadu Prospective Cohort Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Ramya |
| Designation |
PhD Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No. 12 Vembuliamman Koil Street, West K K nagar, Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
7305629425 |
| Fax |
|
| Email |
yoginiramya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Uma Maheswari |
| Designation |
Assistant Professor |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No. 12 Vembuliamman Koil Street, West K K nagar, Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
7708022722 |
| Fax |
|
| Email |
shiny.uma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Ramya |
| Designation |
PhD Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No. 12 Vembuliamman Koil Street, West K K nagar, Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
7708022722 |
| Fax |
|
| Email |
yoginiramya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Academy of Higher Education and Research, (Deemed to be University) West K K nagar, Chennai, India - 600078 |
|
|
Primary Sponsor
|
| Name |
M Ramya |
| Address |
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No. 12 Vembuliamman Koil Street, West K K nagar, Chennai - 600078 |
| Type of Sponsor |
Other [Scholar] |
|
|
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 D Uma Maheswari |
Meenakshi Academy of Higher Education and Research |
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No. 12 Vembuliamman Koil Street, West K K nagar, Chennai - 600078
Chennai
TAMIL NADU |
7708022722
shiny.uma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEENAKSHI ACAEDMY OF HIGHER EDUCATION AND RESEARCH INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vipassana Meditation Practitioner |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Those who attend Ten days course.
2. Those who give consent form.
3. Fresher’s only included.
4. Middle aged people only included.
5. Only Tamil Nadu people |
|
| ExclusionCriteria |
| Details |
1. Active clinical surgery or other major clinically significant disorder/ disease.
2. Those do not give consent form.
3. Those who attend Twenty days and Three days vipassana course are excluded.
4. Adolescents and Children are excluded.
5. Those who are affected with any psychological disorder are excluded.
6.Those who are affected with chronic diseases are excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Yamas Questionnaire
2. Niyamas Questionnaire |
10 Days Vipassana Meditation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/10/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 would be conducted for the partial fulfilment of the Ph.D study at Meenakshi Academy of Higher Education and Research (Deemed to be University), Chennai.
The life is full of misery. But the root cause of
misery is ignorance. Hence, to wipe away the ignorance that causes misery,
following Yama Niyama which are the
tools for achieving ultimate purpose of
life is very important. People who performed 10
days Vipassna meditation course from the city of Chennai between the ages of 35
to 55 years are to be randomly selected, and 200 subjects based
on the Inclusion and Exclusion criteria and to study the impact of Vipassna meditation
through the questionnaires on Yamas and Nyamas. Selected questionnaires would be given to the
observational groups at the end of 10 days Vipassna meditation course by using cross sectional study. |