[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609105":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":39,"locations":45,"responsibleParty":60,"collaborators":31,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":31,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":31,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":85,"whyStopped":31,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Nutraceuticals Research Institute","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Plant Extract 1","EXPERIMENTAL","Participants in this arm will take an ashwagandha root supplement each day for 84 days.",[13],"Dietary Supplement: ashwagandha root",{"label":15,"type":10,"description":16,"interventionNames":17},"Plant Extract 2","Participants in this arm will take an ashwagandha root and leaf supplement each day for 84 days.",[18],"Dietary Supplement: ashwagandha root and leaf",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Participants in this arm will take an inert placebo each day for 84 days.",[24],"Other: Placebo",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIETARY_SUPPLEMENT","ashwagandha root","This substance is extracted from the root of the plant.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"ashwagandha root and leaf","This substance is extracted from both the root and leaves of the plant.",[15],{"type":6,"name":20,"description":37,"armGroupLabels":38,"otherNames":31},"The inert placebo does not contain any of the plant matter.",[20],[40],{"name":41,"role":42,"phone":43,"phoneExt":31,"email":44},"Jessie Cavanaugh, PhD","CONTACT","256-203-9010","j.cavanaugh@nutraceuticalsresearch.com",[46],{"facility":5,"status":31,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Huntsville","Alabama","35801","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-86.58594,34.7304,{"lat":56,"lon":55},[59],{"name":41,"role":42,"phone":43,"phoneExt":31,"email":44},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Jessie Hawkins","Primary Investigator","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":74,"type":75},90,"ESTIMATED","INTERVENTIONAL",[78],"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.",[81,82],"Menopausal Hot Flashes","Menopausal Women",[84],"ashwagandha","NOT_YET_RECRUITING","2025-09-29",{"date":88,"type":89},"2025-10-07","ACTUAL",{"date":91,"type":75},"2025-10-01",{"date":93,"type":75},"2026-03-30",{"name":5,"class":6},1]