| CTRI Number |
CTRI/2024/02/062308 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Yoga] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Mind sound resonance technique (a yogic relaxation) in old age population to identify their physiological and psychological functions. |
|
Scientific Title of Study
|
Effect of Mind sound resonance technique (A yogic relaxation) on physiological and psychological parameters among geriatric population - A Randomized controlled 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 |
PRASHANTH S |
| Designation |
PhD Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research, Chennai |
| Address |
Faculty of Yoga Science and Therapy, Department of Yoga, Meenakshi Academy of Higher Education and Research, 12, Vembuliamman koil street, KK Nagar, Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
7708485651 |
| Fax |
|
| Email |
222909005@maher.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Nalini V |
| Designation |
Assistant Professor |
| Affiliation |
Meenakshi Academy of Higher Education and Research, Chennai |
| Address |
Department of Tamil, Meenakshi Academy of Higher Education and Research, 12, Vembuliamman koil street, KK nagar, Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
7708485651 |
| Fax |
|
| Email |
naliniv@maherfhs.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nalini V |
| Designation |
Assistant Professor |
| Affiliation |
Meenakshi Academy of Higher Education and Research, Chennai |
| Address |
Department of Tamil, Meenakshi Academy of Higher Education and Research, 12, Vembuliamman koil street, KK Nagar, Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
7708485651 |
| Fax |
|
| Email |
naliniv@maherfhs.ac.in |
|
|
Source of Monetary or Material Support
|
| Govt. Yoga and Naturopathy Medical college, Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [no sponcer] |
|
|
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 Mahesh Kumar K |
Govt. Yoga and Naturopathy Medical College and Hospital |
Department of Yoga, Research unit, Arignar anna Indian medicine campus, PP Garden, Arumbakkam, Chennai-600106
Chennai
TAMIL NADU |
9884591739
doctor.mahesh1985@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| govt. Yoga and Naturopathy Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Geriatrics |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Willing to Participate |
|
| ExclusionCriteria |
| Details |
Visual and auditory impairments, severe Organ dysfunctions, involved in other research studies, if doctor not advised to participate |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cardio autonomic function |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| neuro cognitive functions, stress level, Psychological functions |
3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/02/2024 |
| 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
|
Introduction: Aging is a complex process involving physical, psychological, and social changes including chronic non-communicable pathologies and dysfunctions of the hypothalamic-pituitary-adrenal axis (HPA axis).Yoga can help to manage physiological and psychological issues, including HPA axis dysfunction. Mind Sound Resonance Technique (MSRT), a relaxation technique, has been shown to alleviate stress, anxiety, and improve psychomotor function in both clinical and non-clinical populations. Aim: To report the methodology for three months of MSRT sessions and their impact on the physiological and psychological parameters among the geriatric population. Methods: A randomized controlled trail with the sample size of 80 participants who all are aged between 60 to 75 years. They will be divided into Intervention group and control group with 40 samples in each group. The intervention group will be given with the MSRT sessions for 45mins a day for a total period of 90 days and the control group will not be given with any intervention during the study period. After 90 days intervention post assessment will be taken and compared with control group. Conclusion: MSRT; referred to have a dual benefit as meditative effect along with its relaxation component, might enhance the physiological and psychological functions to enhance the well-being of geriatric population. Expected outcome on the cardio autonomic, pulmonary, neurocognitive, psychological functions and the changes in serum stress marker (biomarker).
|