| CTRI Number |
CTRI/2023/06/054181 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Trataka Kriya on vital parameters such as blood pressure, body
temperature,pulse rate respiratory rate ,pulse oxymetry, Heart rate variability |
|
Scientific Title of Study
|
Effect of Trataka Kriya on Vital Parameters and Heart Rate Variability among College Students |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D SRILEKHA |
| Designation |
PG Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of mind body medicine and lifestyle sciences
Sri Ramachandra institute of higher education and research
Porur, chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8883795970 |
| Fax |
|
| Email |
a3921002@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D C Mathaingi |
| Designation |
Prof and head |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Department of mind body medicine and lifestyle sciences, SRFAHS
Sri Ramachandra Institute of Higher Education and Research, Porur ,Chennai
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9940635874 |
| Fax |
|
| Email |
dcmathangi@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr D C Mathaingi |
| Designation |
Prof and head |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Department of mind body medicine and lifestyle sciences, SRFAHS
Sri Ramachandra Institute of Higher Education and Research, Porur ,Chennai
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
09940635874 |
| Fax |
|
| Email |
dcmathangi@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra institute of higher education and research |
| 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 |
| D Srilekha |
Sri Ramachnadra Institute of Higher Education and research |
Dept of mind body medicine and lifestyle sciences
Thiruvallur
TAMIL NADU |
8883795970
a3921002@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE, SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
COLLEGE STUDENTS BETWEEN THE AGE OF 18 - 25
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Duration of practice of the Trataka Kriya |
We will be having two groups based on the duration of the kriya practice i.e 5 minute to 10 minute of practice |
| Intervention |
Trataka kriya |
Focusing on a light/lamp for 5 to 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.College students of SRIHER
2.Individuals who understand English .
3.Willingness and ability to participate in the trataka kriya practice session
|
|
| ExclusionCriteria |
| Details |
•Individuals with medication for any disorder.
•Individuals with eye conditions (including refractive errors of the eye), Eye infection, or surgery.
•Individuals with headache
•Yoga practitioner
•Individuals with psychological or psychiatric disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| vital parameters, heart rate variability |
Pre and Post intervention assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of practice on the parameters assessed |
Practice duration would be either 5 min or 10 minutes |
| Sustenance of the change in parameters assessed post the specified duration of practice |
every 10 min post the kriya session till a final 30 min period |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
Final Enrollment numbers achieved (Total)= "41"
Final Enrollment numbers achieved (India)="41" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/07/2023 |
| Date of Study Completion (India) |
14/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Cleansing practices are part of most indigenous health systems practiced in Yoga. The practice of trataka involves concentrated gazing on a small object (usually a candle flame). . The technique is said to reduce the eye disorders and to reduce the laziness . The scientific studies on Trataka used cognitive functions and vision as their outcome measures. Several studies were explored on trataka kriya to assess the effects ,cognitive function(memory ,attention), eye sight improvement, vital parameters and heart rate variability . There is dearth of studies exploring the sustenance of change in vital parameters and heart rate variability after the trataka kriya .Hence this study has been proposed to evaluate the effect of trataka in vital parameters and heart rate variability .And to observe the sustenance of change in vital parameters and heart rate variability.Hence this study focuses on observing the effect Trataka on vital parameters and heart rate variability among college students. |