Herbal Nutraceutical Supplementation on Vasomotor Symptoms in Menopausal Women (NCT05813067) | Clinical Trial Compass
CompletedNot Applicable
Herbal Nutraceutical Supplementation on Vasomotor Symptoms in Menopausal Women
United States74 participantsStarted 2022-12-27
Plain-language summary
The role of nutrition is recognized as a vital component to healthy aging throughout menopause. The goal of this study is to evaluate a dietary supplement for its safety and effects on vasomotor symptoms in menopausal women.
Who can participate
Age range40 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Healthy menopausal women who are 40 to 65 years of age (inclusive).
✓. Last menstrual period has occurred at least 6 months prior to screening.
✓. MRS score ≥2 at screening and at baseline.
✓. Have self-reported menopausal symptoms for the past 6 months.
✓. Have self-reported at least five moderate to severe hot flashes per day (including night sweats), on average for 7 days
✓. Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
✓. In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
✓. Have normal vital signs or acceptable to the investigator vital signs (blood pressure and heart rate) at screening.
Exclusion criteria
✕. Individuals who are lactating, pregnant or planning to become pregnant during the study.
✕. Induced menopause through surgery such as bilateral oophorectomy or salpingo-oophorectomy, chemotherapy, radiation, or drugs.
✕. Individuals who have had a partial or total hysterectomy.
✕. Use of any treatment for menopausal symptoms or other concomitant treatments listed under the "concomitant therapies" section of the protocol
What they're measuring
1
To determine the effects of the Test Product (TP) compared to placebo on hot flash symptoms as determined by the Hot Flash Related Daily Interference Scale (HFRDIS).
✕. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
✕. Received a vaccine for COVID-19 in the two weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis).
✕. Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (e.g., lyme disease, TB, HIV).
✕. Have uncontrolled high blood pressure (≥160 mmHg systolic or ≥100 mmHg diastolic) or thyroid disease, defined as not taking a stable dose of medication on the current regimen for a minimum of three months.