| CTRI Number |
CTRI/2025/11/097814 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management of menopausal symptoms |
|
Scientific Title of Study
|
An open label randomized comparative clinical trial to evaluate the effect Of Shatavaryadi Ghrita with Brahmi Churna versus Sukumara Ghrita with Brahmi Churna in the management Of menopausal symptoms (Rajo Nivrutti Lakshan)” |
| 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 Jashanvir Kaur |
| Designation |
Post Graduate Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B |
| Address |
Room no A 205 Department of Prasuti Tantra Evam Stree Roga Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
7973584290 |
| Fax |
|
| Email |
jashanvir05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu Kumari |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh |
| Address |
Room no A 205 Department of Prasuti Tantra Evam Stree Roga Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
8219654933 |
| Fax |
|
| Email |
indu.kaund@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jashanvir Kaur |
| Designation |
Post Graduate Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B |
| Address |
Room no A 205 Department of Prasuti Tantra Evam Stree Roga Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
7973584290 |
| Fax |
|
| Email |
jashanvir05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh 160047 India |
|
|
Primary Sponsor
|
| Name |
Dr Jashanvir Kaur |
| Address |
Room no A 205 Prasuti Tatra Evam Stree Roga Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh 160047 India |
| 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 Jashanvir Kaur |
Shri Dhanwantry Ayurvedic College and Hospital |
OPD no 106 Department of Prasuti Tantra Evam Stree Roga Old block
Chandigarh
CHANDIGARH |
7973584290
jashanvir05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh 160047 |
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: RAJONASAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Brahmi Churna, Reference: Bhavprakash Nighantu pg 447, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavaryadi Ghrita, Reference: Sahastrayog Ghrit Prakaran, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brahmi churna, Reference: Bhavprakadh Nighantu pg 447, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sukumara Ghrita, Reference: Sahastrayog Ghrita Prakaran, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Amenorrhea more than or equal to 12 months
Endometrial thickness less than or equal to 5mm
Signed informed consent to participate in trial |
|
| ExclusionCriteria |
| Details |
Surgical menopause
On hormonal replacement therapy
Any pre existing psychological disorders
Uncontrolled case of diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the severity and frequency of menopausal Symptoms |
Baseline to 60 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Menopause – Specific Quality of Life
|
Baseline to 60 th day |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/12/2025 |
| 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="1"
Months="3"
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
|
Menopause
is the physiological cessation of menstruation after the reproductive phase in
a woman’s life. It generally occurs between 45–55 years of age and is marked by
significant hormonal changes due to ovarian insufficiency. This transition is
often accompanied by symptoms such as hot flashes,
mood swings, insomnia, joint pain, and urogenital disturbances, which significantly reduce
the quality of life. The Ayurvedic perspective considers this condition under Rajo
Nivrutti Lakshan, a natural aging process involving Vata
predominance and Dhatu Kshaya . This trial is to evaluate and
compare the effect of Shatavaryadi Ghrita
with Brahmi Churna Versus Sukumara Ghrita with Brahmi Churna in
the management of Menopausal Symptoms (Rajo Nivrutti Lakshan).
The
trial will be performed in two groups one will be given Shatavaryadi ghrita
(6g before food with water ) with Brahmi churna (3g after food with
water ) and second group will be given Sukumara ghrita (6g before food
with water ) with Brahmi churna (3g after food with water ). Patient
will be assessed on basis of MRS (Menopausal rating scale ) and MEN-QOL
(Menopausal Quality of life ) . Taking the hypothesis under consideration wheather Shatavaryadi Ghrita with Brahmi Churna is as effective as compared to Sukumara Ghrita with Brahmi Churna in the management of Menopausal Symptoms. The observation and result will be analyzed
statistically with relevant tests and level of significance will be reported .
|