| CTRI Number |
CTRI/2024/02/062544 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of yogic sleep technique on blood flow to the brain |
|
Scientific Title of Study
|
Effect of yoga nidra on frontal hemodynamic changes among
elderly people |
| 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 A Ragasudha |
| Designation |
PG Scholar |
| Affiliation |
Government yoga and naturopathy medical college and hospital |
| Address |
Department of Yoga, Second floor, Government yoga and naturopathy medical college and hospital,PG block,Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
07639715541 |
| Fax |
|
| Email |
ragasudha496@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mooventhan A |
| Designation |
Assistant medical officer cum lecturer, Department of Research |
| Affiliation |
Government yoga and naturopathy medical college and hospital |
| Address |
Department of Research, Second floor, Government yoga and naturopathy medical college and hospital,PG block,Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Ragasudha |
| Designation |
PG Scholar |
| Affiliation |
Government yoga and naturopathy medical college and hospital |
| Address |
Department of Yoga, Second floor, Government yoga and naturopathy medical college and hospital,PG block, Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
07639715541 |
| Fax |
|
| Email |
ragasudha496@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai-600106 |
| Type of Sponsor |
Government 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 A Ragasudha |
Government yoga and naturopathy medical college and hospital |
2nd floor, Department of Yoga,PG block, Arumbakkam, Chennai-600106 -
Chennai
TAMIL NADU |
07639715541
ragasudha496@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government yoga and naturopathy medical college and hospital, Chennai institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Yoga nidra |
Yoga nidra is a mindfulness based practice in which the subjects should be in lie down position with eyes closed and they should follow the instructions from the audio |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elderly people |
|
| ExclusionCriteria |
| Details |
Subjects with more than 2 comorbidities.
Not willing to participate in the study.
Subjects with mental illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cerebral hemodynamics of pre frontal cortex |
Cerebral hemodynamics of pre frontal cortex will be assessed before and after the intervention on first and tenth day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depression, Anxiety Stress Scale (DASS-21) |
DASS-21 score will be taken on first and tenth day of intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/03/2024 |
| 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="2"
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
|
Yoga nidra is a mindfulness based intervention. It is a mental state between wakefulness and sleep. In elderly persons, neurodegeneration and dementia were common and both linked to cerebral hypoperfusion. Mindfulness based interventions improves cerebral hemodynamics. But there is no particular study has examined the effect of yoga nidra on cerebral hemodynamics. Functional near infrared spectroscopy (fNIRS) is a tool to measure cerebral blood flow. A single group pre-post study design will be adopted for this study. 30 subjects will be recruited for the study. Subjects will undergo yoga nidra practice for 25 minutes, once a day for 10 days. Assessment will be taken before and after the intervention on first and tenth day. |