[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577099":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":36,"studyPopulation":26,"armGroups":37,"interventions":55,"overallOfficials":26,"centralContacts":69,"locations":75,"responsibleParty":92,"collaborators":26,"id":96,"slug":26,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":26,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":26,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":77,"whyStopped":26,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Nutraceuticals Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Post-test Cortisol Awakening Response, after controlling for baseline scores","salivary cortisol levels will be taken immediately after waking and 30 minutes later to produce a composite score","60 days",{"measure":14,"description":15,"timeFrame":12},"NRI-SS (Nutraceuticals Research Institute's Stress Scale)","This is a validated scale measuring 6 subdomains of stress. It is measured on a likert scale. Scores on each subdomain can range from 5 to 42, with higher scores indicating greater stress levels.",[17,20,23],{"measure":18,"description":19,"timeFrame":12},"NRI-ES (Nutraceuticals Research Institute's Energy Scale)","This is a validated scale measuring 6 subdomains of energy. It is measured on a likert scale. Scores on each subdomain can range from 5 to 42, with higher scores indicating greater energy levels.",{"measure":21,"description":22,"timeFrame":12},"NRI-Sleep (Nutraceuticals Research Institute's Sleep Scale)","This is a validated scale measuring 7 subdomains of sleep. It is measured on a likert scale. Scores on each subdomain can range from 5-42 with higher scores indicating greater quality of sleep",{"measure":24,"description":25,"timeFrame":12},"NRI-Cognition Scale","This is a validated scale measuring 6 subdomains of cognition. It is measured on a likert scale. Scores on each subdomain can range from 5-42 with higher scores indicating greater quality of cognitive health",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":6,"observationalModel":26,"timePerspective":26,"maskingInfo":30},"RANDOMIZED","PARALLEL",{"masking":31,"maskingDescription":26,"whoMasked":32},"TRIPLE",[33,34,35],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","Participants will take one of two extracts or a placebo every day for 60 days; outcomes of stress, sleep, energy, and cognition will provide information on effectiveness.",[38,44,49],{"label":39,"type":40,"description":41,"interventionNames":42},"Plant Extract 1","EXPERIMENTAL","Participants in this arm will take an ashwagandha root supplement each day for 60 days.",[43],"Dietary Supplement: ashwagandha root",{"label":45,"type":40,"description":46,"interventionNames":47},"Plant Extract 2","Participants in this arm will take an ashwagandha root and leaf supplement each day for 60 days.",[48],"Dietary Supplement: ashwagandha root and leaf",{"label":50,"type":51,"description":52,"interventionNames":53},"Placebo","PLACEBO_COMPARATOR","Participants in this arm will take an inert placebo each day for 60 days.",[54],"Other: placebo",[56,61,65],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":26},"DIETARY_SUPPLEMENT","ashwagandha root","This substance is extracted from the root of the plant.",[39],{"type":57,"name":62,"description":63,"armGroupLabels":64,"otherNames":26},"ashwagandha root and leaf","This substance is extracted from both the root and leaves of the plant.",[45],{"type":6,"name":66,"description":67,"armGroupLabels":68,"otherNames":26},"placebo","The inert placebo does not contain any of the plant matter.",[50],[70],{"name":71,"role":72,"phone":73,"phoneExt":26,"email":74},"Jessie Hawkins, PhD","CONTACT","256-203-9010","j.hawkins@nutraceuticalsresearch.com",[76],{"facility":5,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"RECRUITING","Huntsville","Alabama","35801","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-86.58594,34.7304,{"lat":87,"lon":86},[90],{"name":91,"role":72,"phone":73,"phoneExt":26,"email":74},"JESSIE HAWKINS, PhD",{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jessie Hawkins","PhD","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":107,"type":108},60,"ESTIMATED","INTERVENTIONAL",[111],"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.",[114],"Stress",[116,117,118,119,120],"energy","fatigue","cognition","nutraceuticals","Ashwagandha","2025-01-21",{"date":123,"type":124},"2025-01-27","ACTUAL",{"date":126,"type":124},"2024-10-21",{"date":128,"type":108},"2025-04-30",{"name":5,"class":6},1]