[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100288819":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":22,"centralContacts":22,"locations":26,"responsibleParty":140,"collaborators":22,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":22,"eligibilityCriteria":148,"healthyVolunteers":149,"sex":150,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":22,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":22,"overallStatus":162,"whyStopped":22,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"Materia Medica Holding","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ergoferon","EXPERIMENTAL","Tablet for oral use. Dose per administration - 1 tablet per intake (outside a meal\u002Ffeeding). Within the first 2 hours - 1 tablet every 30 minutes, followed by 3 more tablets at time intervals equally separated throughout the rest of the day; from day 2 to day 5 - 1 tablet 3 times daily.",[13],"Drug: Ergoferon",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":22},"DRUG",null,[9],{"type":21,"name":15,"description":22,"armGroupLabels":25,"otherNames":22},[15],[27,39,48,57,63,72,81,90,96,102,111,120,129],{"facility":28,"status":22,"city":29,"state":22,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":22},"State budgetary Health Care institution of the Arkhangelsk region \"Arkhangelsk Regional Pediatric Clinical Hospital named after PG Vyzhletsova\"","Arkhangelsk","163002","Russia","RU",{"type":34,"coordinates":35},"Point",[36,37],40.55183,64.5461,{"lat":37,"lon":36},{"facility":40,"status":22,"city":41,"state":22,"zip":42,"country":31,"countryCode":32,"cosmosGeoPoint":43,"geoPoint":47,"contacts":22},"Federal State Budgetary Educational Institution of Higher Education \"Kazan Medical University\" of the Ministry of Healthcare of the Russian Federation","Kazan'","420012",{"type":34,"coordinates":44},[45,46],49.12214,55.78874,{"lat":46,"lon":45},{"facility":49,"status":22,"city":50,"state":22,"zip":51,"country":31,"countryCode":32,"cosmosGeoPoint":52,"geoPoint":56,"contacts":22},"Federal Budget Institution of Science \"Central Research Institute of Epidemiology\" of The Federal Service on Customers' Rights Protection and Human Well-being Surveillance","Moscow","111123",{"type":34,"coordinates":53},[54,55],37.61781,55.75204,{"lat":55,"lon":54},{"facility":58,"status":22,"city":50,"state":22,"zip":59,"country":31,"countryCode":32,"cosmosGeoPoint":60,"geoPoint":62,"contacts":22},"Pirogov Russian National Research Medical University","117997",{"type":34,"coordinates":61},[54,55],{"lat":55,"lon":54},{"facility":64,"status":22,"city":65,"state":22,"zip":66,"country":31,"countryCode":32,"cosmosGeoPoint":67,"geoPoint":71,"contacts":22},"Federal State Budgetary Educational Institution of Higher Education \"Orenburg State Medical University\" of the Ministry of Healthcare of the Russian Federation","Orenburg","460000",{"type":34,"coordinates":68},[69,70],55.09883,51.76712,{"lat":70,"lon":69},{"facility":73,"status":22,"city":74,"state":22,"zip":75,"country":31,"countryCode":32,"cosmosGeoPoint":76,"geoPoint":80,"contacts":22},"Municipal Budgetary Health Care Institution \"Semashko City Hospital №1 Rostov-on-Don \"","Rostov-on-Don","344000",{"type":34,"coordinates":77},[78,79],39.70769,47.21997,{"lat":79,"lon":78},{"facility":82,"status":22,"city":83,"state":22,"zip":84,"country":31,"countryCode":32,"cosmosGeoPoint":85,"geoPoint":89,"contacts":22},"Federal State Budgetary Educational Institution of Higher Education \"Saint Petersburg State Pediatric Medical University\" of the Ministry of Healthcare of the Russian Federation","Saint Petersburg","194100",{"type":34,"coordinates":86},[87,88],30.31413,59.93863,{"lat":88,"lon":87},{"facility":91,"status":22,"city":83,"state":22,"zip":92,"country":31,"countryCode":32,"cosmosGeoPoint":93,"geoPoint":95,"contacts":22},"Sailnt Petersburg State Budgetary Health Care Institution \"City Child Hospital №22\"","196657",{"type":34,"coordinates":94},[87,88],{"lat":88,"lon":87},{"facility":97,"status":22,"city":83,"state":22,"zip":98,"country":31,"countryCode":32,"cosmosGeoPoint":99,"geoPoint":101,"contacts":22},"Federal State Institution \"Scientific Research Institute of Children's Infections Federal Biomedical Agency\"","197022",{"type":34,"coordinates":100},[87,88],{"lat":88,"lon":87},{"facility":103,"status":22,"city":104,"state":22,"zip":105,"country":31,"countryCode":32,"cosmosGeoPoint":106,"geoPoint":110,"contacts":22},"The State Budget Educational institution of High Professional Training Smolensk State Medical University of Ministry of Health Care of the Russian Federation","Smolensk","214018",{"type":34,"coordinates":107},[108,109],32.05088,54.77826,{"lat":109,"lon":108},{"facility":112,"status":22,"city":113,"state":22,"zip":114,"country":31,"countryCode":32,"cosmosGeoPoint":115,"geoPoint":119,"contacts":22},"Federal State Budgetary Educational Institution of Higher Education \"Yaroslavl State Medical University\" of the Ministry of Healthcare of the Russian Federation","Yaroslavl","150000",{"type":34,"coordinates":116},[117,118],39.87368,57.62987,{"lat":118,"lon":117},{"facility":121,"status":22,"city":122,"state":22,"zip":123,"country":31,"countryCode":32,"cosmosGeoPoint":124,"geoPoint":128,"contacts":22},"Federal State Budgetary Institution of Higher Professional Education \"Urals State Medical University\" of the Ministry of Healthcare of the Russian Federation","Yekaterinburg","620028",{"type":34,"coordinates":125},[126,127],60.61529,56.85733,{"lat":127,"lon":126},{"facility":130,"status":22,"city":131,"state":22,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":139,"contacts":22},"Scientific Research Institute of Virology of Ministry of Health of Republic Uzbekistan","Tashkent","100194","Uzbekistan","UZ",{"type":34,"coordinates":136},[137,138],69.21627,41.26465,{"lat":138,"lon":137},{"type":141,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100288819","phase-4-clinical-trial-of-efficacy-and-safety-of-ergoferon-in-the-treatment-of-viral-intestinal-infections-in-children-100288819",true,"NCT03039699","Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Viral Intestinal Infections in Children","International Multicenter, Double-blind, Randomized, Parallel Group Placebo-Controlled Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Viral Intestinal Infections in Children","Inclusion Criteria:\n\n1. Patients of both gender aged from 6 months to 6 years, who have been admitted to infectious diseases unit.\n2. Diarrhea (watery diarrhea at least 3 times a day).\n3. CDS score of ≥1.\n4. The first 48 hours from the onset of the first diarrhea episode.\n5. Start of study treatment (Ergoferon\u002FPlacebo) within 12 hours after the start of the standard hospital therapy.\n6. Availability of a patient information sheet (Informed Consent form) signed by the patient's parents\u002Fadopters to confirm the child's participation in the clinical trial signed by one parent\u002Fadopter of the patient.\n\nExclusion Criteria:\n\n1. Suspected bacterial intestinal infection.\n2. Suspected infectious diseases affecting other organ systems (e.g. pneumonia, meningitis, sepsis, otitis media, urinary tract infection, etc.).\n3. Severe intestinal infection.\n4. Severe dehydration (CDS score ≥7).\n5. Anuria (acute kidney injury).\n6. Medical history or prior diagnosis of serious diseases, including primary\u002Fsecondary immunodeficiency, oncological disease, diabetes mellitus, infantile cerebral palsy, mucoviscidosis\u002Fcystic fibrosis etc.\n7. Exacerbation, or decompensation of chronic disease, including diseases of the digestive system that would affect the patient's ability to participate in the clinical trial.\n8. Malabsorption syndrome, including congenital or acquired lactose intolerance\u002Flactase deficiency or any other disaccharidase deficiency and galactosemia.\n9. Allergy\u002F intolerance to any of the components of medications used in the treatment.\n10. Course intake of medicines listed in the section \"Prohibited concomitant treatment\" for 2 weeks prior to the enrollment in the trial.\n11. Participation in other clinical trials within 3 months prior to the enrollment in this study.\n12. Patients whose parents\u002Fadopters, from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the dosing regimen of the study drugs.\n13. Patient's parents\u002Fadopters are related to the research staff of the clinical investigative site who are directly involved in the trial or are the immediate family member of the researcher. The immediate family members include husband\u002Fwife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.\n14. The patient's parent\u002Fadopter works for MATERIA MEDICA HOLDING (i.e., is the company's employee, temporary contract worker or appointed official responsible for carrying out the research) or the immediate relative.",false,"ALL","6 Months","6 Years",{"count":154,"type":155},259,"ACTUAL","INTERVENTIONAL",[158],"PHASE4","The purpose of this study is to obtain additional data on efficacy and safety of Ergoferon in the treatment of viral intestinal infections in inpatient children.",[161],"Viral Intestinal Infection","COMPLETED","2020-09-23",{"date":165,"type":155},"2020-10-19",{"date":167,"type":155},"2016-06-23",{"date":169,"type":155},"2019-06-01",{"name":5,"class":6},13]