NCT07834463 · India Glycols Ltd
Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW)
(RENEW)
What this study is about
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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
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.
OTHER
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.
Primary outcome measures
Change in Menopause Rating Scale (MRS) Total Score
Time frame: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
Change in menopausal symptom severity from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), as assessed using the Menopause Rating Scale (MRS). The MRS consists of 11 items covering somatic, psychological, and urogenital menopausal symptoms. Each item is scored from 0 (no symptoms) to 4 (very severe symptoms), with a total score ranging from 0 to 44. Higher scores indicate greater severity of menopausal symptoms. A decrease in MRS total score indicates improvement in menopausal symptom burden.
Change in Average Daily Hot Flash Frequency
Time frame: Baseline Run-in Period (7 days before Day 0) to End-of-Study Assessment (Day 56 ± 5 days)
Change in average daily hot flash frequency from the baseline run-in period to the end of treatment. Hot flash frequency will be calculated as the mean number of hot flashes recorded per day during the 7-day baseline run-in period before Day 0 and during the assessment period at the end of treatment. A decrease in average daily hot flash frequency indicates improvement.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 (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.
Where
- New Port Richey, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 22, 2026 · Source of record for eligibility and locations