Ashoka Bark and Shatavari for Menopause

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, placebo-controlled trial will enroll up to 50 postmenopausal women aged 40–65 to receive either the Ashoka Bark and Shatavari supplement or a placebo for 12 weeks. Participants will have visits at baseline, 6 weeks, and 12 weeks to assess hormone levels (FSH and estradiol), menopausal symptoms, quality of life, anxiety, cognitive function, and sleep, along with safety and adherence checks. The study will also explore changes in the vaginal microbiome and collect safety data throughout treatment, conducted at MusB Research in New Port Richey, Florida. The goal is to determine if the botanical combination can alleviate symptoms and potentially influence related biological factors in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Females aged 40-65 years.
* Postmenopausal women in good overall health and fulfilling menopausal criteria set at the MRS score more than 5.
* Subjects had experienced absence of regular menstrual cycle for at least 3 months.
* Willingness to sign consent, follow protocols and regimen intake, as well as maintain normal physical activity and follow study procedures.

Exclusion Criteria:

* Not on Hormone Replacement Therapy (HRT) or had discontinued HRT at least 12 months before admission to the study.
* History of breast cancer,
* BMI ≥ 40mg/kg².
* Prior removal of both ovaries.
* Pregnancy, breastfeeding, or plans for pregnancy.
* History of breast or uterine cancer, including hyperplasia, endometrial carcinoma, or cervical neoplasia.
* Unstable medical conditions or clinically diagnosed depression requiring treatment.
* Self-reported drug or alcohol abuse.
* Allergy or sensitivity to herbal ingredients.
* Undiagnosed abnormal vaginal bleeding;
* A bilateral hysterectomy;
* History of chronic alcoholism,
* Medication hypersensitivity, or allergy to dietary supplement ingredients;
* Acute systemic infection or abnormal laboratory values.
* No antibiotics use in past 30 days.
* No regular probiotics use in past 30 days.

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.