Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW)
Eligible age
45–60 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: India Glycols Ltd
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
New Port Richey
Source: ClinicalTrials.gov · NCT07834463 · last updated 2026-09-22