[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"menopausal-hot-flashes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:menopausal-hot-flashes":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100609105","the-effectiveness-of-a-proprietary-ashwagandha-extract-on-menopausal-symptoms-a-three-arm-randomized-double-blinded-placebo-controlled-clinical-trial-100609105",false,"NCT07210229","The Effectiveness of a Proprietary Ashwagandha Extract on Menopausal Symptoms: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study\n* Baseline score of above-average menopause symptom levels on each of the patient reported scales: NRI-MSS (defined as 22+), the MRS scale (defined as 9+), AND 4+ on the MENQoL.\n* Confirmation of presence of hot flashes\n* Estridiol levels within the bottom 35% of normal ranges for their menstrual cycle phase (follicular\u002Fovulation\u002Fluteal) as established by laboratory reference range\n* Biological sex of female; gender identification of woman\n* Aged 40 to 55, inclusive\n* Good general health as evidenced by medical history and screening\n* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study\n* Still menstruating regularly (defined at least one period every 60 days)\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n\nExclusion Criteria:\n\n* Pregnant, trying to conceive, or breastfeeding\n* Hysterectomy, uterine ablation, or related procedure\n* Amenorrhea\n* Consumes \\> 8 alcoholic beverages in an average week\n* Currently consumes an ashwagandha supplement or has consumed one regularly (defined as 1x week or more often) within the past 24 months\n* Consumes any hormonal therapies or menopause-related supplements intended to improve symptoms in any way\n* Current or recent (within 60 days) history of taking thyroid medications, hypertensive drugs, CNS depressants, diabetic medications, benzodiazepines, or immunosuppressants\n* Any liver, kidney, hormonal, or cardiovascular disorder\n* Known allergic reactions to any components of the intervention\n* Recent dramatic weight changes (10% change in body weight in the last 6 months)\n* Introducing a new investigational drug or other intervention within 60 days before the start of the study\n* Any change to diet or lifestyle within 60 days before the start of the study (defined as introducing any new exercise activity, joining a gym, starting a new routine, moving to a new home, adjusting dietary habits (e.g. vegetarian, paleo, etc) or discontinuing any habits or diets.\n* Any health or medical condition which, in the primary investigators opinion, may interfere with the conduct of the study","FEMALE","40 Years","55 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on symptoms of menopause and hormone levels, as compared to a placebo.",[26,27],"Menopausal Hot Flashes","Menopausal Women",[29],"ashwagandha","NOT_YET_RECRUITING","2025-09-29",{"date":33,"type":34},"2025-10-07","ACTUAL",{"date":36,"type":20},"2025-10-01",{"date":38,"type":20},"2026-03-30",{"name":40,"class":41},"Nutraceuticals Research Institute","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":17,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":63,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":42},"100594705","a-trial-to-investigate-the-accuracy-of-a-wearable-device-in-collecting-data-related-to-perimenopausal-symptoms-in-women-100594705","NCT07022925","A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women","An Observational Virtual Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women","Inclusion Criteria:\n\n1. Females between 35-55 years of age, inclusive\n2. Self-reported perimenopausal women experiencing hot flushes or night sweats\n3. Individuals of child-bearing potential must confirm they are not pregnant, do not plan to become pregnant, and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include:\n\n   * Double-barrier method\n   * Intrauterine devices\n   * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)\n   * Vasectomy of partner at least 6 months prior to screening\n   * Abstinence\n4. Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, supplements\u002Fmedications, and sleep\n5. Provided voluntary and informed consent to participate in the study\n6. Generally healthy as determined by medical history with no unstable diagnosed medical conditions\n\nExclusion Criteria:\n\n1. Allergy or sensitivity to adhesive used for wearing the investigational device\n2. Self-reported use of a pacemaker\n3. Self-reported unstable diagnosed anxiety disorder\n4. Self-reported sleep disorder requiring medical treatment\n5. Self-reported skin conditions or sensitive skin around the area of application\n6. Self-reported surgery in the past three months or individuals who have planned surgery during the course of the study\n7. Alcohol intake average of ˃1 standard drink per day\n8. Alcohol or drug abuse within the last 12 months that has required treatment\n9. Current use of prescribed and\u002For over-the-counter (OTC) medications\u002Fsupplements that may impact data recorded by the investigational device (see Section 7.3)\n10. Participation in other clinical research studies 30 days prior to screening\n11. Individuals who are unable to give informed consent\n12. Any other condition or lifestyle factor, that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant","35 Years",{"count":52,"type":20},110,"OBSERVATIONAL","The goal of this observational study is to investigate the accuracy of the device in characterizing perimenopausal and menopausal symptoms including vasomotor symptoms, anxiety, sleep quality compared to self-reported symptoms via an app. The main question it aims to answer is:\n\nWhat is the accuracy of the developed algorithm from the investigational device compared to daily self-report via an app in characterizing perimenopausal symptoms?\n\nParticipants will be asked to wear IndentifyHer's wearable non-invasive sensor and complete a daily electronic diary and questionnaires on stress, anxiety, and sleep.",[56,57,58,59,60,26,61,62],"Perimenopause","Perimenopausal Depression","Perimenopausal Insomnia","Perimenopausal Women","Menopausal Depression","Menopausal and Postmenopausal Disorders","Menopausal Vasomotor Symptoms",[64,56,65,66,67,68,69],"Menopause","Vasomotor symptoms","Hot flashes","IdentifyHer","Peri","Perimenopausal symptoms","RECRUITING","2025-09-17",{"date":73,"type":34},"2025-09-18",{"date":75,"type":34},"2025-07-04",{"date":77,"type":20},"2025-10",{"name":79,"class":80},"IdentifyHer Limited","INDUSTRY"]