Shatavari-based herbal extract to help menopausal symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial will enroll about 100 postmenopausal women aged 45 to 60 who experience menopausal symptoms and have a hot flash frequency of at least three per day. Participants will receive either the Shatavari-based extract or a matching placebo daily for 8 weeks, with assessments including symptom questionnaires, a daily hot-flash diary, blood tests, and safety monitoring. Primary outcomes focus on overall menopausal symptom burden and hot flashes; secondary analyses explore mood, sleep, skin and hair health, and exploratory biomarkers such as CRP, IL-6, FSH, estradiol, and LH. The study uses validated scales and endpoints to evaluate non-hormonal management options for menopausal symptoms. Participants will undergo screenings and periodic assessments at baseline, mid-point, and end of study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female subjects aged 45-60 years at screening.
* Post-menopausal status, defined as no menstrual period for at least 12 months, graded as post-menopausal per STRAW classification (not due to pregnancy, lactation, or medical/surgical causes).
* Menopause Rating Scale (MRS) score \> 9 at screening.
* Average frequency of hot flashes \>= 3 per day for at least 7 consecutive days prior to screening.
* Willing and able to provide written informed consent and comply with study procedures, including maintaining the daily hot-flash diary.

Exclusion Criteria:

* Body mass index (BMI) \<= 18 kg/m2 or \> 35 kg/m2.
* History of endometrial hyperplasia, endometrial cancer, cervical cancer, breast cancer, or other sex hormone-related cancers.
* History of uterine resection or hysterectomy.
* Unexplained abnormal uterine bleeding occurring after \>= 1 year of menopause.
* History of severe migraine, or diagnosis of thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or history of coronary angioplasty within 1 year prior to screening.
* Currently undergoing treatment for severe disease of the cardiovascular, immune, respiratory, gastrointestinal/hepatobiliary, renal/urologic, nervous, or musculoskeletal system, or for infectious disease or malignancy.
* Psychiatric disorders: clinically diagnosed depression, anxiety disorder, or sleep disorder within 3 months prior to screening treated with medication, or current use of neuropsychiatric drugs.
* Use of thyroid hormones, clonidine, anticoagulants, antiplatelet agents (e.g., warfarin, clopidogrel), or osteoporosis treatments within 3 months prior to screening.
* Use of any medication or plant-based hormone-like extract for menopausal symptoms within 3 months prior to screening.
* Continuous intake of health functional foods related to menopause or herbal medicine within 1 month prior to screening.
* Uncontrolled hypertension (resting blood pressure \>= 160/100 mmHg after 10 minutes of rest).
* Uncontrolled diabetes (fasting blood glucose \>= 180 mg/dL or HbA1c \> 9.5%).
* Excessive use of tobacco (\>20 cigarettes/day), caffeine (\>5 cups/day), or alcohol (\>14 drinks/week) within 4 weeks prior to screening.
* History of clinically reported drug abuse within 1 year prior to screening.
* Known clinically significant hypersensitivity to any component or excipient of the investigational product.
* Participation in another interventional clinical trial within 1 month prior to study start.
* Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation.

Where it's running

• MusB Research LLC
  New Port Richey, Florida, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.