Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW)

Menopause is associated with a range of symptoms that may substantially affect quality of life, including vasomotor symptoms such as hot flashes and night sweats, sleep disturbances, mood changes, and changes in skin and hair health. Although hormone therapy can be effective for menopausal symptoms, some women seek non-hormonal approaches.

This study is designed to evaluate a standardized herbal extract containing Shatavari with natural bio-enhancer ingredients as a potential non-hormonal approach for managing menopausal symptoms. The study will use a randomized, double-blind, placebo-controlled design to compare the test product with a matching placebo over an 8-week intervention period.

The primary evaluation will focus on changes in overall menopausal symptom burden and hot flash symptoms. Additional evaluations will examine depressive symptoms, sleep quality, self-reported skin health, and self-reported hair and scalp health. Safety and tolerability will also be monitored throughout the study.

Exploratory assessments will evaluate changes in selected inflammatory and hormonal biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), follicle-stimulating hormone (FSH), estradiol, and luteinizing hormone (LH). Changes in thigh and hip circumference will also be explored as anthropometric measures.

Participants will undergo screening, baseline/randomization, mid-study, and end-of-study assessments. Study-related information will be collected using validated questionnaires, participant diaries, laboratory assessments, vital signs, anthropometric measurements, and adverse-event monitoring. Participants will be followed for adherence to the study product and completion of study assessments.

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.