[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577099":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":63,"collaborators":31,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":31,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":31,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":48,"whyStopped":31,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"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 60 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 60 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 60 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":37,"description":38,"armGroupLabels":39,"otherNames":31},"placebo","The inert placebo does not contain any of the plant matter.",[20],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Jessie Hawkins, PhD","CONTACT","256-203-9010","j.hawkins@nutraceuticalsresearch.com",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Huntsville","Alabama","35801","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-86.58594,34.7304,{"lat":58,"lon":57},[61],{"name":62,"role":43,"phone":44,"phoneExt":31,"email":45},"JESSIE HAWKINS, PhD",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Jessie Hawkins","PhD","100577099","effects-of-ashwagandha-extract-on-stress-levels-100577099",false,"NCT06793891","Effects of Ashwagandha Extract on Stress Levels","The Effectiveness of a Proprietary Ashwagandha Extract on Stress Reduction: 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* Self reported high stress\n* Baseline score of above-average stress levels on the NRI-SS\n* Biological sex of woman; gender identification of female\n* Aged 30 to 59, 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* Agreement to adhere to Lifestyle Considerations throughout study duration\n\nExclusion Criteria:\n\n* Pregnancy, trying to conceive, or breastfeeding\n* Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year\n* Consumes \\> 8 alcoholic beverages in an average week\n* Is a primary caretaker for a child younger than 18 months of age\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 stress aid, medication, diet, or supplement intended to improve stress 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 or kidney disorder\n* Known allergic reactions to any components of the intervention\n* Positive COVID-19 test within 30 days of the study period\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* Introducing a new lifestyle stress-reduction aid (i.e. physical activity, yoga, etc) within 60 days before the start of the study",true,"FEMALE","30 Years","59 Years",{"count":79,"type":80},60,"ESTIMATED","INTERVENTIONAL",[83],"NA","The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on stress levels, with secondary outcomes of cognition, energy, and sleep, as compared to a placebo.",[86],"Stress",[88,89,90,91,92],"energy","fatigue","cognition","nutraceuticals","Ashwagandha","2025-01-21",{"date":95,"type":96},"2025-01-27","ACTUAL",{"date":98,"type":96},"2024-10-21",{"date":100,"type":80},"2025-04-30",{"name":5,"class":6},1]