| CTRI Number |
CTRI/2025/11/096876 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study on Shatavari Capsules for the treatment of Menopausal Symptoms in women. |
|
Scientific Title of Study
|
A Multicenter, Randomized, Double Blind, Placebo Controlled, Comparative, Clinical Study to evaluate the Efficacy and Safety of Shatavari Capsules for the treatment of Menopausal Symptoms in women. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-MS-001 Version No 1.0 Dated 04 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alaka C Godbole |
| Designation |
Principal Investigator |
| Affiliation |
Akshaya Surgical and Maternity Home |
| Address |
Department of gynaecology, Ground Floor, Kolbad Naka, Old Agra Road, Thane (W) – 400601
Thane
MAHARASHTRA
400601
India |
| Phone |
9833967970 |
| Fax |
|
| Email |
godbole369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt Ltd |
| Address |
SB-02, 03 and 04, Second Floor Highland Corporate Centre, Kapurbawdi Junction, Thane West Maharashtra, India
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt Ltd |
| Address |
SB-02, 03 and 04, Second Floor Highland Corporate Centre, Kapurbawdi Junction, Thane West Maharashtra, India
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| MotherSoul Private Limited,
Plot No, EC-77, Ring Rd,
Near Bombay Hospital Service Road, Scheme No: 94,
Shanti Niketan Colony, Indore,
Madhya Pradesh – 452010 |
|
|
Primary Sponsor
|
| Name |
MotherSoul Private Limited |
| Address |
Plot No, EC-77, Ring Rd, Near Bombay Hospital Service Road, Scheme No: 94,
Shanti Niketan Colony, Indore, Madhya Pradesh – 452010 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alaka C Godbole |
Akshaya Surgical and Maternity Home |
Department of gynaecology, Ground Floor, Kolbad Naka, Old Agra Road, Thane (W) – 400601.
Thane
MAHARASHTRA |
9833967970
godbole369@gmail.com |
| Dr T Sasikala |
Government Medical College And Government General Hospital (Old RIMSGGH) |
Department of Gyneacology, OPD No: 07,Ground Floor, Srikakulam- 532001, Andhra Pradesh, India
Srikakulam
ANDHRA PRADESH |
9573405562
drtsasikala@gmail.com |
| Dr Amit Agrawal |
Terna Speciality Hospital and Research Centre |
Department of Gyanecology, Plot No-12, Sector-22, Opp. Nerul Railway Station, Phase II, Nerul(W), Navi Mumbai-400706
Mumbai
MAHARASHTRA |
9437163294
dramitagrawal19@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethicare Ethics Committee Ethicare Ethics Committee |
Approved |
| Ethicare Ethics Committee Ethicare Ethics Committee |
Approved |
| Institutional Ethics committee Government General Hospital Srikakulam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N958||Other specified menopausal and perimenopausal disorders. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavari Capsules, Reference: Shatavari root extract, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: One capsule to be taken orally twice a day, in the morning and evening,
one hour after breakfast and dinner, for 60 days. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Placebo Capsules, Reference: -, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 00(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: One capsule to be taken orally twice a day, in the morning and evening, one hour after breakfast and dinner, for 60 days. |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Adult menopausal female participants, 40 to 70 years of age (both inclusive).
2. Perimenopausal and postmenopausal participants who are experiencing bothersome Vasomotor Symptoms. Perimenopause is defined as amenorrhea for greater than 60 days in the past 12 months; post menopause is defined as being without a menstrual cycle due to spontaneous reasons for the preceding 12 months.
3. Participants with menopause symptoms, defined as a score of greater than or equal to 9 to less than or equal to 16 in the Menopausal Rating Scale (MRS) at screening (includes both peri-menopausal and post-menopausal women).
4. Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures. |
|
| ExclusionCriteria |
| Details |
1. Participants with a known history of hypersensitivity to the study medication or any of the ingredients of the formulation.
2. Participants with present active medical, surgical, and gynaecological problems.
3. History of malignancy or any ongoing malignancy.
4. Participants with known history of uncontrolled hypertension and uncontrolled Type 2 Diabetes Mellitus.
5. Participants with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts); or cerebrovascular accident.
6. Participants with clinically relevant current or past history of severe, unstable, or uncontrolled pulmonary, hepatic, endocrine, neurological, rheumatological and renal diseases necessitating medical care.
7. Participants who are on hormone replacement therapy (HRT) for more than 3 months.
8. Participants taking medications such as glucocorticoids, anticonvulsants, antipsychotics, anxiolytics, antidepressants, opioid pain relievers, hypnotics, methotrexate, etc. or any other drugs that may have an influence on the outcome of the study.
9. Participants with sleep disturbances and who are on prescription/over the counter/herbal/nutraceutical or any other system of therapy for sleep related concerns.
10. Participants using phytoherbal supplements, herbal extracts, nutraceuticals, or ayurvedic supplements 3 months prior to screening.
11. Participants who are consuming or planning to consume soy/estrogenic foods like soybean oil or other estrogenic diet supplements.
12. Any other health or mental condition or any significant laboratory parameters that in the investigators opinion may adversely affect the participants ability to complete the study or its measures or that may pose significant risk to the participant.
13. Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
14. Participants who are pregnant or lactating or planning to become pregnant during the study period. Participants who are not ready to use acceptable contraceptive methods during the course of study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion in Menopause Rating Scale (MRS) assessment from baseline to end of study. |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in Menopause Rating Scale (MRS) assessment from baseline to end of study. |
60 Days |
| Mean change in Utian Quality of life Scale (UQOL) assessment from baseline to end of study. |
60 Days |
Mean change in Depression Anxiety Stress Scale (DASS-21) assessment from baseline
to end of study. |
60 Days |
| Mean change in Greene Climacteric Scale assessment from baseline to end of study. |
60 Days |
Safety Endpoint:
The assessment of safety of Investigational Product will be based on incidence of AEs, SAEs and changes in laboratory parameters. |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
10/11/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A Multicenter Randomized Double Blind Placebo Controlled Comparative Clinical Study to evaluate the Efficacy and Safety of Shatavari Capsules for the treatment of Menopausal Symptoms in women.
Primary Objective:
To evaluate the efficacy of Shatavari Capsules for the treatment of Menopausal Symptoms in women.
Secondary Objective:
To evaluate the safety of Shatavari Capsules for the treatment of Menopausal Symptoms in women. |