[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100368126":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":25,"locations":33,"responsibleParty":47,"collaborators":25,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":25,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Azienda Ospedaliera Universitaria Policlinico \"G. Martino\"","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"KalobaTuss children","EXPERIMENTAL","KalobaTuss children syrup 5 ml for 4 times a day supplied for 8 consecutive days.",[13],"Dietary Supplement: KalobaTuss children",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo syrup 5 ml for 4 times a day supplied for 8 consecutive days.",[19],"Dietary Supplement: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Syrup, dosage: 5 ml for 4 times a day for 8 days.",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":31,"role":32},"Gioacchino Calapai, MD","Azienda Ospedaliera Universitaria \"G Martino\", Messina, Italy.","PRINCIPAL_INVESTIGATOR",[34],{"facility":35,"status":25,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":25},"Gioacchino Calapai","Messina","Me","98125","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],15.55256,38.19394,{"lat":45,"lon":44},{"type":32,"investigatorFullName":35,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"FULL PROFESSOR OF PHARMACOLOGY AND TOXICOLOGY","100368126","efficacy-safety-and-palatability-of-the-syrup-kalobatuss-children-for-the-treatment-of-cough-in-children-100368126",false,"NCT04073251","Efficacy, Safety and Palatability of the Syrup \"KalobaTuss® Children\" for the Treatment of Cough in Children","Randomized, Controlled, Double Blind Clinical Study on the Assessment of Efficacy, Safety and Palatability of \"KalobaTuss® Children\", a Syrup for the Treatment of Cough in Pediatric Age (3-6 Years).","KALOCOUGH","Inclusion Criteria:\n\n* Healthy children aged between 3 and 6 years, with persistent cough for at least three consecutive days.\n\nExclusion Criteria:\n\n* Children with history of obstructive pulmonary diseases, cystic fibrosis, neuropathies, heart disease, diabetes and immunodeficiencies were excluded.",true,"ALL","3 Years","6 Years",{"count":62,"type":63},106,"ACTUAL","INTERVENTIONAL",[66],"NA","Cough of children is one of the most frequent events for which parents ask for a medical consult and it is a true challenge for pediatrics during daily practice.\n\nIn the majority of cases, it is self-limiting, but its persistence could become exasperating and it could reduce quality of life and social activities.\n\nEven if inappropriate prescription of antitussive pharmacological treatment in children has been reduced, pediatrics prescribing attitudes do not still always are reflecting accurate treatment of cough.\n\nFurthermore, pediatric approach is always compromised by parental exaggerate perception of symptoms and usual consequent requirement of pharmacological prescription of antibiotics, that they consider the appropriate and effective therapeutic option for cough.\n\nThe World Health Organization identifies honey as a potential demulcent treatment for cough.\n\nOn the light of the above considerations and since available pediatric treatments for acute cough are limited by lack of demonstrated efficacy, a pediatric cough syrup product containing Acacia honey as well as specific fractions of resins, polysaccharides, saponins, flavonoids and sugars derived from Malva sylvestris extract, Inula helenium, Plantago major extract, Helichrysum stoechas (KalobaTuss) was developed to be clinically tested on persisting cough of children. Investigators evaluated through a randomized, double blind controlled clinical study the effects of KalobaTuss on persistent cough in children aging 3-6 years. The effects of Kalobatuss were compared with effects of placebo on nocturnal and daytime persistent cough for eight days. Objective of the study was to evaluate the clinical efficacy of KalobaTuss by using as primary endpoint the assessment of changes in day- and night-time cough score.",[69],"Cough",[71,72],"Persistent cough","Children","COMPLETED","2019-08-28",{"date":76,"type":63},"2019-08-29",{"date":78,"type":63},"2019-02-15",{"date":80,"type":63},"2019-05-10",{"name":5,"class":6},1]