Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW)
Start Date
9/1/2026
Completion Date
8/31/2027
Summary
This study will evaluate whether an 8-week course of a standardized herbal extract containing Shatavari and natural bio-enhancer ingredients can reduce menopausal symptoms in post-menopausal women. The study will compare the herbal extract with a matching placebo. Approximately 100 women aged 45 to 60 years with menopausal symptoms will be enrolled, with approximately 80 expected to complete the study. Participants will take one study product daily for 8 weeks. Menopausal symptoms, including hot flashes, mood, sleep, skin health, and hair and scalp health, will be assessed using questionnaires, a daily hot flash diary, blood tests, and safety assessments.
Detailed Description
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.
Eligibility Criteria
Age Range: 45 years to 60 years
Interventions
Shatavari (Asparagus racemosus) Extract
Placebo
Conditions
Locations
MusB Research LLC
New Port Richey, Florida 34653
United States