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โ† Trials
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Satavari and Ashoka for Menopause (SAM) Study

RecruitingNAAges 40 Years - 65 YearsFemaleVidya USA Corporation
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In plain words

What the trial is, and whether it could suit you

This 12-week randomized, placebo-controlled clinical trial will evaluate the efficacy and safety of a daily oral supplement containing Ashoka Bark and Shatavari in women experiencing menopausal symptoms. Up to 50 participants will be randomized to receive either the active supplement or placebo, with 40 participants expected to complete the study. Participants will attend visits at Weeks 0, 6, and 12, where hormone levels (FSH and estradiol), menopausal symptoms, quality of life, anxiety, cognitive function, and sleep will be assessed using validated measures. The study will also explore changes in the vaginal microbiome and monitor safety and adherence throughout the trial. The study will be conducted at MusB Research in New Port Richey, Florida.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 40mg/kgยฒ. * 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.
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What it tests

  • Ashoka Bark and Shatavari
  • Placebo
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Where

1 site
MusB Research LLC
New Port Richey, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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