A study to find out if Shatavari (asparagus racemosus) is safe and helps improve hormone balance in healthy women of reproductive age.

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. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/092062

Enrollment

Registered

2025-07-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E289- Ovarian dysfunction, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: Baseline (Day 0), 1st Follow up visit (Day 30), 2nd Follow up visit (Day 60), Last follow up visit (Day 90)	—

Measure

Time frame

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.Timepoint: Baseline (Day 0), 1st Follow up visit (Day 30), 2nd Follow up visit (Day 60), Last follow up visit (Day 90)

—

Secondary

Measure	Time frame
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-IRTimepoint: Day 0, Day 90	—

Countries

India

Contacts

Public ContactDr Sudeep Kumar Patra

Indivirtus Global CRO Pvt. Ltd.

director.research@indivirtus.com9861252518

Outcome results