Herbal Dietary Supplementation on Vasomotor Symptoms in Menopausal Women (NCT07408115) | Clinical Trial Compass
CompletedNot Applicable
Herbal Dietary Supplementation on Vasomotor Symptoms in Menopausal Women
United States112 participantsStarted 2024-05-24
Plain-language summary
The goal of this study is to evaluate the efficacy of a neurokinin 1,3 antagonist on improving vasomotor symptoms (VMS) and overall menopause symptoms in women between the ages of 40-70. The primary research question is whether taking the study product daily for 4 weeks with an optional 8 week extension, significantly reduces the severity and frequency of menopause-related symptoms.
Who can participate
Age range40 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. Healthy women who are 40 to 70 years of age (inclusive).
✓. Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
✓. Have self-reported menopausal symptoms for the past 6 months.
✓. Have self-reported ≥5 moderate to severe hot flashes per day, on average for 7 days.
✓. In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
✓. Agree to refrain from treatments listed in the defined timeframe.
✓. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Exclusion criteria
✕. Individuals who are lactating, pregnant, or planning to become pregnant during the study.
✕. Use of any treatment for menopausal symptoms or other concomitant treatments listed.
✕. 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).
What they're measuring
1
Change from Baseline on Hot Flash Symptoms assessed by the number and severity of hot flashes and times awakened at night due to night sweats collected via participant diary tracking electronically.
Timeframe: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks
2
Change from Baseline on Hot Flash Symptoms assessed via Hot Flash Related Daily Interference Scale (HFRDIS) scores.
Timeframe: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks
3
Change from Baseline on Hot Flash Symptoms assessed via the Visual Analog Scale Vasomotor Symptoms Questionnaire (VAS).
Timeframe: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks
4
Change from Baseline on Overall Menopausal Symptoms assessed via the Greene Climacteric Scale (CGS).
Timeframe: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks
5
Change from Baseline on Overall Menopausal Symptoms assessed via the Menopause Rating Scale (MRS).
Timeframe: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks
6
Change from Baseline on Overall Menopausal Symptoms assessed via the Visual Analog Scale Vasomotor Symptoms Questionnaire (VAS).
Timeframe: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks
✕. Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (i.e., Lyme disease, TB, HIV).
✕. History of cancer (except localized skin cancer without metastases) within two years prior to screening.
✕. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study or influence the results or the potential subject's ability to participate in the study.
✕. History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e., Crohn's disease, short bowel, acute or chronic pancreatitis, gastric bypass procedures, or pancreatic insufficiency).