| CTRI Number |
CTRI/2026/03/106431 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A comparative study on the effect of Shatavari ghee with and without mantra therapy for improving mental health symptoms in menopausal women |
|
Scientific Title of Study
|
An open label comparative clinical study to evaluate the effect of dvadasha avartita brihat shatavari ghrita and add on effect of mantra chikitsa w.s.r to manovikara in menopuasal syndrome |
| 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 Gadiraju Sri kala |
| Designation |
MD Scholar (Manasaroga) |
| Affiliation |
Sri dhramasthala manjunatheswara college of ayurveda hospital and research centre |
| Address |
OPD3,Department of pg studies in manovijnana evum manasa roga
SDM college of ayurveda kuthpady
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
8072892802 |
| Fax |
|
| Email |
srikalagadiraju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayendra G bhat |
| Designation |
BAMS MD (Ayu) |
| Affiliation |
Sri dharmasthala manjunatheshwara college of ayurveda ,hospital and research center |
| Address |
OPD3,Department of pg studies in manovijnana evum manasa roga
SDM college of ayurveda kuthpady
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
7019021611 |
| Fax |
|
| Email |
ayurvijay25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gadiraju Sri kala |
| Designation |
MD Scholar (Manasaroga) |
| Affiliation |
Sri dharmasthala manjunatheshwara college of ayurveda ,hospital and research center |
| Address |
OPD3,Department of pg studies in manovijnana evum manasa roga
SDM college of ayurveda kuthpady
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
8072892802 |
| Fax |
|
| Email |
srikalagadiraju@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Gadiraju Sri kala pg scholar
Sri dharmasthala manjunatheshwara college of ayurveda ,hospital and research center,kuthpady,udupi-574118 |
|
|
Primary Sponsor
|
| Name |
DrGadiraju Sri kala |
| Address |
Sri dharmasthala manjunatheshwara college of ayurveda ,hospital and research center,kuthpady,udupi |
| 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 |
| Dr Gadiraju Sri kala |
Sri dharmasthala manjunatheshwara college of ayurveda ,hospital and research center,kuthpady,udupi |
OPD3,Dept of Manasaroga,Sri dharmasthala manjunatheshwara college of ayurveda ,hospital and research center,kuthpady,udupi
Udupi
KARNATAKA |
8072892802
srikalagadiraju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SDM COLLEGE OF AYURVEDA UDUPI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: dvadasha avartita brihat satavari ghrita, Reference: charaka samhitha chikitsasthana 30th chapter 641/2-1/269, Route: Oral, Dosage Form: Ghrita, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: ushnajala), Additional Information: - | | 2 | Comparator Arm | Procedure | - | mantra-cikitsA, मन्त्र-चिकित्सा | (Procedure Reference: charaka samhitha sutra sthana 11th chapter, Procedure details: Mantrachikitsa: Mantra chikitsa- ( audio therapy) Recorded Audio of repetitive chanting of particular mantra from Sri Lalitha Sahasra namaavali (Manasvini Maanavati Mahesi Mangalakrutih) listen for half an hour in morning . Protocol to be followed for mantra chikitsa– In the early morning between 5am to 6am (Brahma muhurta) After the completion of bowel evacuation and personal hygiene, sit in a calm and quiet place in Sukhasana or any other comfortable posture. Maintain an upright spine, gently close your eyes, and focus your attention on the mantra. Listen to the mantra for a duration of 30 minutes.)
(1) Medicine Name: dvadasha avartita brihath satavari ghrita, Reference: charaka samhitha yonivyapath chikitsa, Route: Oral, Dosage Form: Ghrita, Dose: 2(ml), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Women age group of 40-55 years
2. Patient fulfilling diagnostic criteria of natural menopause
3. Patients willing to sign informed consent |
|
| ExclusionCriteria |
| Details |
1.patients with premature menopause
2.patients with surgical menopause
3. patients under hormonal therapy
4. patients with other psychiatric, psychosomatic disorders and systemic illness |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 30th day
1.Menopausal rating scale
2.Manasika bhava assessment scale
All scored parameters will be analyzed
statistically after the treatment on 30th day. All
the subjective parameters and scales will be
assessed using Wilcoxon signed rank test
within the groups and Mann-Whitney U test in
between the groups. |
Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 30th day
1.Menopausal rating scale
2.Manasika bhava assessment scale
All scored parameters will be analyzed
statistically after the treatment on 30th day. All the subjective parameters and scales will be assessed using Wilcoxon signed rank test within the groups and Mann-Whitney U test in between the groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improvement in associated menopausal symptoms
emotional well being |
|
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
14/04/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is an open label comparative interventional clinical study to evaluate the effectiveness of Dvadasha Avartita Brihat Shatavari Ghrita alone and in combination with MantraChikitsa in managing Manovikara associated with menopausal syndrome. The study will be conducted in Shri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi. A total of 30 naturally menopausal women (40–55 years) will be randomly allocated into two groups. Group A will receive Dvadasha Avartita Brihat Shatavari Ghrita orally for 30 days, while Group B will receive the same medication along with MantraChikitsa (audio-based mantra listening). Assessment will be done using the Menopause Rating Scale and Manasika Bhava Assessment Scale before and after treatment. Statistical analysis will evaluate both within-group and between-group efficacy. Hence, the study aims to scientifically validate Ayurvedic rasayana and daivavyapashraya approaches in addressing menopausal psychological symptoms and to assess whether the addition of MantraChikitsa provides superior therapeutic benefit, thereby contributing to holistic menopausal care. |