[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"India Glycols Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100657063","randomized-evaluation-of-natural-extract-for-menopausal-wellness-renew-100657063",false,"NCT07834463","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","RENEW","Inclusion Criteria:\n\n* Female subjects aged 45-60 years at screening.\n* 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\u002Fsurgical causes).\n* Menopause Rating Scale (MRS) score \\> 9 at screening.\n* Average frequency of hot flashes \\>= 3 per day for at least 7 consecutive days prior to screening.\n* Willing and able to provide written informed consent and comply with study procedures, including maintaining the daily hot-flash diary.\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\\u003C= 18 kg\u002Fm2 or \\> 35 kg\u002Fm2.\n* History of endometrial hyperplasia, endometrial cancer, cervical cancer, breast cancer, or other sex hormone-related cancers.\n* History of uterine resection or hysterectomy.\n* Unexplained abnormal uterine bleeding occurring after \\>= 1 year of menopause.\n* 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.\n* Currently undergoing treatment for severe disease of the cardiovascular, immune, respiratory, gastrointestinal\u002Fhepatobiliary, renal\u002Furologic, nervous, or musculoskeletal system, or for infectious disease or malignancy.\n* 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.\n* Use of thyroid hormones, clonidine, anticoagulants, antiplatelet agents (e.g., warfarin, clopidogrel), or osteoporosis treatments within 3 months prior to screening.\n* Use of any medication or plant-based hormone-like extract for menopausal symptoms within 3 months prior to screening.\n* Continuous intake of health functional foods related to menopause or herbal medicine within 1 month prior to screening.\n* Uncontrolled hypertension (resting blood pressure \\>= 160\u002F100 mmHg after 10 minutes of rest).\n* Uncontrolled diabetes (fasting blood glucose \\>= 180 mg\u002FdL or HbA1c \\> 9.5%).\n* Excessive use of tobacco (\\>20 cigarettes\u002Fday), caffeine (\\>5 cups\u002Fday), or alcohol (\\>14 drinks\u002Fweek) within 4 weeks prior to screening.\n* History of clinically reported drug abuse within 1 year prior to screening.\n* Known clinically significant hypersensitivity to any component or excipient of the investigational product.\n* Participation in another interventional clinical trial within 1 month prior to study start.\n* Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation.","FEMALE","45 Years","60 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29],"Menopause","Hot Flashes",[28,31,32,33,34,35,36,37,38,39],"Postmenopausal women","Menopausal symptoms","Hot flashes","Vasomotor symptoms","Shatavari","Asparagus racemosus","Herbal extract","Sleep quality","Quality of life","RECRUITING","2026-09-16",{"date":43,"type":44},"2026-09-22","ACTUAL",{"date":46,"type":44},"2026-09-01",{"date":48,"type":22},"2027-08-31",{"name":50,"class":51},"India Glycols Ltd","INDUSTRY",""]