| CTRI Number |
CTRI/2025/02/080601 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [mantra chanting] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of maha Mantra Chanting on Menopausal mild depression |
|
Scientific Title of Study
|
A Study of Effect of Maha Mantra Chanting on Mild Depression during Menopause
|
| 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. Shilpa Yerme |
| Designation |
Professor |
| Affiliation |
S.G.R.Ayurved College,Solpaur |
| Address |
kusummanik apt.solpur
Budhwar Peth ,solapur
Solapur
MAHARASHTRA
423002
India |
| Phone |
9822887906 |
| Fax |
|
| Email |
shilpa.yerme@sgrayurved.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shilpa Yerme |
| Designation |
Professor |
| Affiliation |
S.G.R.Ayurved College,Solpaur |
| Address |
kusummanik apt.flat 7 ,solapur
Budhwar Peth ,solapur
Solapur
MAHARASHTRA
423002
India |
| Phone |
9822887906 |
| Fax |
|
| Email |
shilpa.yerme@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shilpa Yerme |
| Designation |
Professor |
| Affiliation |
S.G.R.Ayurved College,Solpaur |
| Address |
kusummanik apt.solapur
Budhwar Peth ,solapur
Solapur
MAHARASHTRA
423002
India |
| Phone |
9822887906 |
| Fax |
|
| Email |
shilpa.yerme@sgrayurved.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Ayurved & Research Center, Pimpri Pune 18 |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil College of Ayurved Research Center Pimpri Pune |
| Address |
Dr D Y Patil College of Ayurved & Research Center
Pimpri Pune 18
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shilpa yerme |
Akash Speciality Hospital ,Solapur |
3-4 Ganesh Nagar ,Hyderabad Road Solapur
Solapur
MAHARASHTRA |
09822887906
yermeshilpa@gmail.com |
| Dr Shilpa Yerme |
Dr DY Patil Ayurved College Pune |
Kriyasharir Dept. Dr shilpa Yerme DR DY Patil Ayurved college and hospital Pune
Pune
MAHARASHTRA |
9822887906
yermeshilpa@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr D Y Patil College of Ayurved Research Centre (Dr DYPCA and RC) Institutional Ethics Committee |
Approved |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mild depression during Menopause |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mantra-cikitsA, मन्त्र-चिकित्सा | (Procedure Reference: Anant samhita, Procedure details: 15 Minutes )
|
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Menopause women between 45 to 60 will be included for study with mild depression having Meno -D scale in between 12 -24 points. |
|
| ExclusionCriteria |
| Details |
Meno -D scale more than 24,Menopause with other systemic disease like Hypothyrodism,hypertension,Diabetes will be excluded from study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study highlights the potential of Mantra Chanting as a therapeutic tool for managing menopausal depression in Indian women |
after intervention with mantra chanting in mild depression during menopause subjects will be assessed on the basis of Meno -D scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increased awareness & education about the benefits of the use of Mantra Chanting ,coupled with integration into holistic health practices such as yoga & meditation could enhance the quality of life for menopausal women. |
mantra chanting efficiency will be assessed on 7th 15th,21 ,31 th day during study period of 18 months on the basis of Meno D scale |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="3"
Months="1"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Menopausal depression is
having greater prevalence with 28.7 world wide and 42% in Maharashtra. this depression further leads with various
complication such as suicidal attempts, family disputes, social losses etc.
research studies shows that Mantra therapy has a marvelous effect on mental health.
Maha mantra is a very powerful mantra which shows a very good effect on various
health problems. Mantra chanting gives surprising results in psychosomatic
diseases. Depression is treated by psychotherapy, Rasayan, counselling Satvavjaya and Daivavyapashray chikitsa. Cost effective easy treatment modules are
necessary to boost mental health |