| CTRI Number |
CTRI/2025/07/092062 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out if Shatavari (asparagus racemosus) is safe and helps improve hormone balance in healthy women of reproductive age. |
|
Scientific Title of Study
|
A randomized double-blind placebo-controlled multicentric clinical study to evaluate the safety and efficacy of Shatavari (asparagus racemosus) in improving hormonal health in healthy reproductive women. |
| 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 Bhagyashree Purna Satpathy |
| Designation |
Asst. Professor, Dept. of Streeroga and Prasuti Tantra Sri Sri Ayurvedic College and Hospital |
| Affiliation |
Sri Sri Ayurvedic College and Hospital Sri Sri University |
| Address |
Dept. of Streeroga and Prasuti Tantra
Sri Sri Ayurvedic College and Hospital
Sri Sri University
Sri Sri Vihar
Ward No - 3
Godi Sahi
Cuttack - 754006
Odisha
India
Dept. of Streeroga and Prasuti Tantra
Sri Sri Ayurvedic College and Hospital
Sri Sri University
Sri Sri Vihar
Ward No - 3
Godi Sahi
Cuttack - 754006
Odisha
India
Cuttack
ORISSA
754006
India |
| Phone |
9348062527 |
| Fax |
|
| Email |
satpathybhagyashree92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saiprasanna Behera |
| Designation |
Director Research, Indivirtus Global CRO Pvt. Ltd. |
| Affiliation |
Indivirtus Global CRO Pvt. Ltd. |
| Address |
Indivirtus Global CRO Pvt. Ltd.
521-522
Top Floor
Taj Plaza
TDI City
Sector-118
Mohali
Punjab
India 160059
Chandigarh
CHANDIGARH
160059
India |
| Phone |
9861252518 |
| Fax |
|
| Email |
director.research@indivirtus.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudeep Kumar Patra |
| Designation |
Chief Operating Officer, Indivirtus Global CRO Pvt. Ltd. |
| Affiliation |
Indivirtus Global CRO Pvt. Ltd. |
| Address |
Indivirtus Global CRO Pvt. Ltd.
521-522
Top Floor
Taj Plaza
TDI City
Sector-118
Mohali
Punjab
India 160059
Indivirtus Global CRO Pvt. Ltd.
521-522
Top Floor
Taj Plaza
TDI City
Sector-118
Mohali
Punjab
India 160059
Chandigarh
CHANDIGARH
160059
India |
| Phone |
9861268508 |
| Fax |
|
| Email |
sudeep.coo@indivirtus.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri Ayurvedic College and Hospital
Sri Sri University
Sri Sri Vihar
Ward No - 3
Godi Sahi
Cuttack - 754006
Odisha
India |
|
|
Primary Sponsor
|
| Name |
Aurea Biolabs (P) Limited |
| Address |
G-285
Main Avenue
Panampilly Nagar
Cochin – 682036
Kerala
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indivirtus Global CRO Pvt Ltd |
521-522
Top Floor
Taj Plaza
TDI City
Sector-118
Mohali
Punjab
India 160059 |
|
|
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 |
| DrP S R S PRAVALLIKA |
Akkineni Womens Hospital |
D.NO. 54-20 10-12, Srinagar Colony, Bharati Nagar
Serv ice Road, Vijayawada 520008,Andhra Pradesh, India.
Visakhapatnam
ANDHRA PRADESH |
9603933338
praveerudraraju@gmail.com |
| Dr Bhagyashree Purna Satpathy |
Sri Sri Ayurvedic College and Hospital |
Department of Streeroga and Prasuti Tantra
Sri Sri Ayurvedic College and Hospital
Sri Sri University
Sri Sri Vihar
Ward No - 3
Godi Sahi
Cuttack - 754006
Odisha
India
Cuttack
ORISSA |
9348062527
satpathybhagyashree92@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Akkineni Womens Hospital |
Approved |
| KIDS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E289||Ovarian dysfunction, unspecified. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavari, Reference: HerStasis, Route: Oral, Dosage Form: Churna/ Powder, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: ), Additional Information: (2) Medicine Name: Shatavari, Reference: HerStasis, Route: Oral, Dosage Form: Churna/ Powder, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: ), Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Placebo Matching Capsule |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Female |
| Details |
Fertile women between 30 - 42 years of age (in reproductive age)
Normal BMI, not obese or underweight (BMI range 18.5 to 29.9)
Experiencing symptoms associated with hormonal imbalance like:
MEDI-Q: Moderate symptoms
Borderline Hormone levels in accordance with the table below (as per Gynecologists): Hormone Inclusion Range Units
Estradiol (E2): 30-70 pg/mL
Progesterone: 0.2-0.6 ng/mL
FSH: 3.5-5.5 IU/ml
LH: 8-15 IU/ml
Testosterone: 35–48 ng/dL
DHEA: 150-300 mcg/dL
AMH: 3-5 ng/mL
All these tests will be done on Day 2 ± 1 of the Menstrual Cycle Phase i.e., early follicular phase |
|
| ExclusionCriteria |
| Details |
Unwillingness to sign the Inform Consent Form.
Females with PCOS, primary ovarian failure, thyroid dysfunction, hyperprolactinemia, systemic illnesses, malignancy.
Pregnant and lactating females
Secondary dysmenorrhea diagnosed (fibroids, endometriosis, or cysts), presence of a history of abortion
Use of antidepressants and/or psychotropic medication in the last two months
Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment.
Subject has a history of alcohol or other drug abuse in the past year. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood Hormone Tests – will be done in the range as per the table in inclusion criteria on the 2nd day of all the cycles (4 cycles) - Total of 4 points
(a)Estradiol
(b)FSH
(c)Luteinizing Hormone (LH)
(d)Total Testosterone
(e)Progesterone
(f)Anti-Mullerian Hormone (AMH)
(g)DHEA
Improvement of the regularity of periods will be analyzed by MEDI-Q.
Assessment of the severity of symptoms and their impact on health-related quality of life (HRQoL) by MEDI-Q Questionnaire. |
Baseline (Day 0), 1st Follow up visit (Day 30), 2nd Follow up visit (Day 60), Last follow up visit (Day 90) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Nature of cycle
2. Duration of cycle
3. Duration of flow
4. Amount of flow
5. CBC
6. RFT
7. LFT
8. Serum Cortisol
9. HOMA-IR |
Day 0, Day 90 |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The study population consists of healthy premenopausal women aged 30 - 42 years who are experiencing symptoms of hormonal imbalance, such as irregular menstrual cycles, mood swings, anxiety, and loss of libido. These participants are selected based on their eligibility criteria, ensuring a homogenous group suitable for evaluating the investigational product’s efficacy and safety. Participants must exhibit borderline hormonal levels based on the inclusion criteria, measured on Day 2 ± 1 of the menstrual cycle (early follicular phase). Hence, 60 subjects must be enrolled and receive either a test product or Placebo in this study at the investigative site as per the nature of the population mentioned above. |