| CTRI Number |
CTRI/2022/09/045305 [Registered on: 07/09/2022] Trial Registered Prospectively |
| Last Modified On: |
06/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of meditation on menopausal depression |
|
Scientific Title of Study
|
Effect of Mind Sound Resonance Technique (MSRT) on depression in perimenopausal and postmenopausal women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASMITA VEVILA MONTEIRO |
| Designation |
Intern |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
SDM College of Naturopathy and Yogic Sciences
Ujire
Belthangady
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
7259929448 |
| Fax |
|
| Email |
dr.asmitavevila@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHASHIKIRAN H C |
| Designation |
Assistant Professor of Research Methodology |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Sri Dharmasthala Manjunatheswara College of Naturopathy and
Yogic Sciences
Ujire
Belthangady
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9483004440 |
| Fax |
|
| Email |
bnysresearch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHASHIKIRAN H C |
| Designation |
Assistant Professor of Research Methodology |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Sri Dharmasthala Manjunatheswara College of Naturopathy and
Yogic Sciences
Ujire
Belthangady
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9483004440 |
| Fax |
|
| Email |
bnysresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Yoga and Nature Cure Hospital Shantivana |
|
|
Primary Sponsor
|
| Name |
ASMITA VEVILA MONTEIRO |
| Address |
SDM College of Naturopathy and Yogic Sciences Ujire Belthangady Dakshina Kannada Karnataka 574240 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Asmita Vevila Monteiro |
SDM Yoga and Nature Cure hospital Shantivana |
SDM Yoga and Nature Cure hospital Shantivana Dharmasthala 574216
Dakshina Kannada
KARNATAKA |
7259929448
dr.asmitavevila@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F328||Other depressive episodes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mind Sound Resonance Technique |
MSRT given for 30 mins everyday for 10 days |
| Comparator Agent |
Supine Rest |
Supine Rest given for 30 mins everyday for 10 days |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women with cessation of menstruation for at least 12 months
Women with a score of above 16 on the CES D (Center for Epidemiological Studies Depression Scale)
Women willing to participate with signed informed consent
|
|
| ExclusionCriteria |
| Details |
Women with history of Major Depressive Disorder, Seasonal Affective Disorder, dysthymia or other psychiatric disorders
Women having regular menstrual cycle
Women undergoing Hormonal replacement therapy
Women under antidepressant or anxiolytic drugs
Women having serious medical illness or mental retardation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CES D Center for Epidemiological Studies Depression Scale |
Before intervention on Day 0 and after intervention on Day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MENQOL The Menopause specific Quality of Life Questionnaire |
Before intervention on Day 0 and after intervention on Day 10 |
| WHQ The Womens Health Questionnaire |
Before intervention on Day 0 and after intervention on Day 10 |
|
|
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)
|
15/09/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is being conducted to determine the effectiveness of Mind Sound Resonance Technique on depressive symptoms and Quality of life among Perimenopausal and Postmenopausal women
60 subjects are taken and divided into 2 groups
Group 1 will be given Mind Sound Resonance Technique for 30 minutes everyday for 10 days
Group 2 will be given Supine Rest for 30 minutes everyday for 10 days
Baseline assessment will be done using CES D MENQOL and WHQ and the same will be assessed after 10 days
The aim is to evaluate the effect of MSRT on depression among Perimenopausal and Postmenopausal women |