| CTRI Number |
CTRI/2025/10/096231 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| 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 Hormonal Balance and Menstrual Health in Women with PCOS. |
|
Scientific Title of Study
|
A Multicenter, Randomized, Double Blind, Placebo Controlled, Comparative, Clinical Study to evaluate the Efficacy and Safety of Shatavari (Asparagus racemosus) Capsules for management of Hormonal Balance and Menstrual Health in women with Polycystic Ovarian Syndrome (PCOS). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-MS-002 Version No 1.0 Dated 25 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 |
09833967970
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 gynaecology, 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:E282||Polycystic ovarian syndrome. Ayurveda Condition: GRANTHIBUTA-ARTAVADUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Placebo Capsule, Reference: --, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 00(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 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 90 days. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavari (Asparagus racemosus), Reference: Reference: Bhava Prakasha Nighantu, Guduchyadi Varga, Shloka No. 186-187, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 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 90 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Adult female participants, 18 to 40 years of age (both inclusive) both married or unmarried.
2. Participants with USG confirmed diagnosis of polycystic ovarian disease.
3. Participants with LH/FSH ratio greater than or equal to 2:1.
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 uterine fibroid, polyp, adenomyosis, ovarian mass or tumour.
3. Participants with a known history of tubercular endometriosis.
4. Participants with known history of congenital adrenal hyperplasia, congenital absence or deformities of uterus and ovaries.
5. Participants having congenital anomalies in the female genital tract.
6. Participants with a current use of hormonal contraceptives or any drugs that may have an influence on the outcome of the study.
7. Participants who have been using fertility drugs within 6 months of the study.
8. Participants diagnosed with premature ovarian failure and dysfunctional uterine bleed.
9. Participants with a history of malignancy or any ongoing malignancy.
10. Participants with known history of uncontrolled hypertension or uncontrolled Type 2 Diabetes Mellitus.
11. Participants with any thyroid abnormalities or dysfunctions at screening.
12. 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.
13. Participants with clinically relevant current or past history of severe, unstable, or uncontrolled pulmonary, hepatic, endocrine, neurological, rheumatological and renal diseases necessitating medical care.
14. Participants using phytoherbal supplements, herbal extracts, nutraceuticals or ayurvedic supplements 3 months prior to screening.
15. 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.
16. Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
17. 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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Luteinizing Hormone/Follicle Stimulating Hormone (LH/FSH) ratio from baseline to end of study. |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in ovarian volume and appearance assessed with pelvic (abdominal) sonography from baseline to end of study. |
90 Days |
| Mean change in total testosterone from baseline to end of study. |
90 Days |
| Mean change in severity of pain during menstruation assessed using Visual Analog Scale from baseline to end of study. |
90 Days |
| Mean change in bleeding using the Menstruation Assessment Chart from baseline to end of study. |
90 Days |
| Mean change in menstrual cycle intervals (in days) assessed with last menstrual period (LMP) from baseline to end of study. |
90 Days |
| Mean change in mood swings using the Hospital Anxiety and Depression Scale (HADS) assessment from baseline to end of study. |
90 Days |
| Mean change in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) assessment from baseline to end of study. |
90 Days |
| Mean change in hirsutism using the modified Ferriman – Gallwey Score assessment from baseline to end of study. |
90 Days |
| Mean change in BMI and waist circumference from baseline to end of study. |
90 Dyas |
Safety Endpoint:
The assessment of safety of Investigational Product will be based on incidence of AEs, SAEs and changes in laboratory parameters. |
90 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="5"
Days="0" |
|
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
|
“A Multicenter, Randomized, Double Blind, Placebo Controlled, Comparative, Clinical Study to evaluate the Efficacy and Safety of Shatavari (Asparagus racemosus) Capsules for management of Hormonal Balance and Menstrual Health in women with Polycystic Ovarian Syndrome (PCOS).”
To evaluate the efficacy of Shatavari (Asparagus racemosus) Capsules for management of Hormonal Balance and Menstrual Health in women with Polycystic Ovarian Syndrome (PCOS).
Secondary Objective:
To evaluate the safety of Shatavari (Asparagus racemosus) Capsules for management of Hormonal Balance and Menstrual Health in women with Polycystic Ovarian Syndrome (PCOS). |