Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW)
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
India Glycols Ltd
100 participants
Sep 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria17
- 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.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07834463