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Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW)
Sponsor: India Glycols Ltd
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.
Official title: An 8-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Herbal Extract With Natural Bio-Enhancer Additives on Menopausal Symptoms in Post-Menopausal Women
Key Details
Gender
FEMALE
Age Range
45 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-09-01
Completion Date
2027-08-31
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
Shatavari (Asparagus racemosus) Extract
Shatavari (Asparagus racemosus) extract provided as a 400 mg oral capsule containing Shatavari extract with natural bio-enhancer additives, including piperine, quercetin, naringin, and silicon dioxide. Participants will take one capsule orally once daily, preferably with water at approximately the same time each day, for 8 weeks. The intervention will be administered under double-blind conditions and compared with a matching placebo.
Placebo
Matching placebo capsule formulated to match the active Shatavari study product in appearance and administration. Participants will take one capsule orally once daily, preferably with water at approximately the same time each day, for 8 weeks. The placebo will contain no active Shatavari extract and will be used as the comparator under double-blind conditions.
Locations (1)
MusB Research LLC
New Port Richey, Florida, United States