[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589409":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":39,"locations":31,"responsibleParty":45,"collaborators":31,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":31,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":76,"whyStopped":31,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":31},{"fullName":5,"class":6},"Azienda di Servizi alla Persona di Pavia","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Leonurus 250 mg","EXPERIMENTAL","Participants in this arm will receive a standardized oral supplement containing 250 mg of Leonurus cardiaca formulated in phospholipids, taken once daily in the morning for 30 days.",[13],"Dietary Supplement: Leonurus cardiaca extract 250 mg",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants in this arm will receive a placebo identical in appearance to the active supplement, taken once daily in the morning for 30 days.",[19],"Dietary Supplement: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Leonurus 500 mg","Participants in this arm will receive a standardized oral supplement containing 500 mg of Leonurus cardiaca formulated in phospholipids, taken once daily in the morning for 30 days.",[24],"Dietary Supplement: Leonurus cardiaca extract 500 mg",[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIETARY_SUPPLEMENT","Leonurus cardiaca extract 250 mg","Participants will receive a dietary supplement containing 250 mg of Leonurus cardiaca extract formulated in phospholipids. The supplement is administered as a single oral capsule, once daily in the morning, for 30 consecutive days.",[9],null,{"type":27,"name":15,"description":33,"armGroupLabels":34,"otherNames":31},"Participants will receive a placebo capsule identical in appearance to the active supplement, administered twice daily for 30 consecutive days.",[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":31},"Leonurus cardiaca extract 500 mg","Participants will receive a dietary supplement containing 500 mg of Leonurus cardiaca extract formulated in phospholipids. The supplement is administered as a single oral capsule, once daily in the morning, for 30 consecutive days.",[21],[40],{"name":41,"role":42,"phone":43,"phoneExt":31,"email":44},"Mariangela Rondanelli","CONTACT","+39 0382381749","mariangela.rondanelli@unipv.it",{"type":46,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100589409","evaluate-the-beneficial-effects-of-an-oral-nutritional-supplement-based-on-leonurus-cardiaca-for-the-improvement-of-mood-and-anxiety-100589409",false,"NCT06954038","Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood and Anxiety","A Randomized, Double Dummy, Placebo-controlled Pilot Study to Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood and Anxiety","LEONORUS","Inclusion Criteria:\n\n* Aged 20 to 50 years\n* Diagnosis of a generalised anxiety disorder (GAD), with manifestations occurring for \\>= 6 months that include excessive worry, poor concentration, restlessness, muscle tension, irritability, fatigue and difficulty sleeping\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Use of hormonal contraceptives in the last 3 months\n* Current diagnosis of major psychiatric disorders (e.g., major depressive disorder, severe anxiety disorders, schizophrenia, bipolar disorder)\n* Known endocrine disorders (e.g., hypothyroidism, hyperthyroidism, diabetes)\n* Use of medications that could affect mood or the menstrual cycle (e.g., SSRIs, anxiolytics, antipsychotics)\n* Severe hepatic or renal impairment\n* Any other serious or unstable medical condition that, in the investigator's judgment, could interfere with study participation","ALL","20 Years","50 Years",{"count":59,"type":60},60,"ESTIMATED","INTERVENTIONAL",[63],"NA","This study aims to evaluate the efficacy and safety of Leonurus cardiaca extract in reducing anxiety symptoms in adults with Generalized Anxiety Disorder (GAD). Sixty drug-free participants aged 20-50 years with a diagnosis of GAD will be randomly assigned to receive either Leonurus cardiaca extract or placebo for 30 days. The primary outcome is the reduction in anxiety symptoms assessed by the SCAG scale. Secondary outcomes include changes in quality of life (SF-12), perceived stress (PSQ), anxiety severity (HAM-A), and anthropometric measures. Safety will be assessed through liver, kidney, and thyroid function tests. Assessments will be conducted at baseline, day 14, and day 30.",[66],"General Anxiety Disorder",[68,69,70,71,72,73,74,75],"Leonurus cardiaca","Herbal extract","Anxiety","SCAG scale","Herbal remedy for GAD","HAM-A","PSQ","SF-12","NOT_YET_RECRUITING","2025-11-23",{"date":79,"type":80},"2025-11-25","ACTUAL",{"date":82,"type":60},"2026-06-15",{"date":84,"type":60},"2026-09-15",{"name":5,"class":6}]