[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656596":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":35,"interventions":51,"overallOfficials":24,"centralContacts":61,"locations":24,"responsibleParty":70,"collaborators":72,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":24,"enrollmentInfo":91,"targetDuration":24,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":24,"overallStatus":102,"whyStopped":24,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":24},{"fullName":5,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Effect of the spray treatment (Ansileve SOS Spray vs placebo spray) on maternal functioning.","Change in maternal functioning after spray administration, measured by the change in BIMF questionnaire score, comparing the Ansileve SOS Spray group with the placebo spray group.","From baseline (T0) to 30 minutes after spray administration (T1).",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Short-term change in emotional impact and anxiety symptoms after Ansileve SOS Spray in parents.","Comparison of changes in scores for the emotional impact of the traumatic event and anxiety symptoms between Ansileve SOS Spray and placebo groups, measured using validated questionnaires (IES-R and GAD-7).",{"measure":18,"description":19,"timeFrame":20},"Long-Term Effects of Ansileve Capsules on Anxiety Symptoms in Parents.","Comparison of changes in GAD-7 anxiety scores after capsule administration between the Ansileve capsule group and the placebo capsule group.","From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).",{"measure":22,"description":23,"timeFrame":20},"Combined effects of Ansileve SOS Spray and Ansileve capsules on anxiety symptoms in parents","Evaluation of the combined effect of Ansileve SOS Spray and Ansileve capsules on anxiety symptoms by comparing changes in GAD-7 scores between the active combination group and the placebo group.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","FACTORIAL","SUPPORTIVE_CARE",{"masking":30,"maskingDescription":24,"whoMasked":31},"TRIPLE",[32,33,34],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[36,42,45,48],{"label":37,"type":38,"description":24,"interventionNames":39},"Arm 1: Ansileve SOS Spray + Ansileve Capsules","ACTIVE_COMPARATOR",[40,41],"Dietary Supplement: Ansileve SOS Spray","Dietary Supplement: Ansileve",{"label":43,"type":6,"description":24,"interventionNames":44},"Arm 2: Ansileve SOS Spray + Placebo Capsules",[40],{"label":46,"type":6,"description":24,"interventionNames":47},"Arm 3: Placebo Spray + Ansileve Capsules",[41],{"label":49,"type":50,"description":24,"interventionNames":24},"Arm 4: Placebo Spray + Placebo Capsules","NO_INTERVENTION",[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":24},"DIETARY_SUPPLEMENT","Ansileve SOS Spray","Dietary supplement in spray containing Ashwagandha, Hawthorn, Hemp seed oil, and Lavender, known to promote relaxation and support emotional balance. It will be administered as 4 sprays under the tongue, three times daily.",[37,43],{"type":53,"name":58,"description":59,"armGroupLabels":60,"otherNames":24},"Ansileve","Dietary supplement in capsule form combining plant extracts of Melissa officinalis and Griffonia simplicifolia, B-group vitamins, and hydrolyzed marine peptides. Two capsules will be administered daily, away from meals.",[37,46],[62,67],{"name":63,"role":64,"phone":65,"phoneExt":24,"email":66},"Cristiana Berti","CONTACT","+39 02 55034338","cristiana.berti@policlinico.mi.it",{"name":68,"role":64,"phone":24,"phoneExt":24,"email":69},"Silvia Bettocchi","silvia.bettocchi.nutrizione@gmail.com",{"type":71,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[73,75,78],{"name":74,"class":6},"University of Milan",{"name":76,"class":77},"Fondazione De Marchi","UNKNOWN",{"name":79,"class":6},"University of Calabria","100656596","effect-of-the-ansileve-supplement-on-the-well-being-of-parents-of-children-who-have-experienced-a-medical-emergency-a-randomized-controlled-study-100656596",false,"NCT07828548","Effect of the Ansileve Supplement on the Well-being of Parents of Children Who Have Experienced a Medical Emergency: A Randomized Controlled Study","Effetto Dell'Integratore Ansileve Sul Funzionamento Genitoriale in Soggetti Esposti a un Evento Emergenziale Per il Bambino: Studio Randomizzato Controllato","ParentSOS","Inclusion Criteria:\n\n* Mothers and fathers of children presenting to the Pediatria Immunoreumatologia Unit of the De Marchi Pediatric Clinic for an acute medical event\n* Age ≥18 years\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Known psychiatric disorders\n* Failure to provide written informed consent\n* Insufficient proficiency in the Italian language\n* Pregnancy or breastfeeding\n* Known allergy or intolerance to one or more components of the food supplement",true,"ALL","18 Years",{"count":92,"type":93},96,"ESTIMATED","INTERVENTIONAL",[96],"NA","The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether the dietary supplement Ansileve (Ansileve SOS spray and Ansileve capsules) can improve psychological well-being and parental functioning in mothers and fathers of children experiencing an acute medical event requiring hospital care.\n\nThe main questions are:\n\n1. Does acute administration of Ansileve SOS spray improve maternal functioning in the short term, as measured by the Barkin Index of Maternal Functioning (BIMF), compared with placebo?\n2. Does Ansileve SOS spray and the subsequent 30-day supplementation with Ansileve capsules reduce anxiety symptoms and improve emotional well-being in parents, compared with placebo?\n\nResearchers will compare participants receiving Ansileve SOS spray and\u002For Ansileve capsules with participants receiving matching placebo products to determine whether the intervention improves parental functioning, reduces anxiety symptoms, and supports psychological recovery after a stressful event involving their child.\n\nParticipants will:\n\n* Be mothers and fathers (≥18 years) of children admitted for an acute medical event at the Pediatria Immunoreumatologia Unit of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico\n* Complete validated questionnaires assessing functioning (BIMF, only mothers), emotional impact of the event \\[Impact of Event Scale - Revised (IES-R)\\], and anxiety symptoms \\[Generalized Anxiety Disorder Scale (GAD-7)\\] at baseline and during follow-up\n* Receive either Ansileve SOS spray or placebo spray at study enrolment.\n* Take either Ansileve capsules or placebo capsules daily for 30 days according to the assigned treatment group\n* Complete a follow-up assessment to evaluate treatment adherence and possible adverse events.",[99,100,101],"Parenting Anxiety","Child Hospitalization","Psychological Well-being","NOT_YET_RECRUITING","2026-09-15",{"date":105,"type":106},"2026-09-18","ACTUAL",{"date":108,"type":93},"2026-09",{"date":110,"type":93},"2027-12",{"name":5,"class":6}]