India Glycols Ltd
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.
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-control…
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…
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.
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.
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