[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598057":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":23,"locations":29,"responsibleParty":97,"collaborators":10,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":10,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":10,"studyType":112,"phases":10,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"POLYSAN Scientific & Technological Pharmaceutical Company","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group",null,"Reamberin® in daily dose 10 mL\u002Fkg + normal saline (NaCl)\u002F5 % or 10 % solution of glucose",[13],"Drug: Reamberin® solution for infusion, 1.5 %",{"label":15,"type":10,"description":16,"interventionNames":10},"Control group","Normal saline NaCl\u002FRinger's solution\u002F5 % or 10 % solution of glucose",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DRUG","Reamberin® solution for infusion, 1.5 %","Reamberin® in daily dose 10 mL\u002Fkg",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Alexey Kovalenko, Doc Biol Sci","CONTACT","+78127108225 Ext. 212","science@polysan.ru",[30,42,50,58,66,71,79,87],{"facility":31,"status":32,"city":33,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":10},"South Ural State Medical University","RECRUITING","Chelyabinsk","Russia","RU",{"type":37,"coordinates":38},"Point",[39,40],61.42877,55.1611,{"lat":40,"lon":39},{"facility":43,"status":32,"city":44,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":45,"geoPoint":49,"contacts":10},"Khimki Clinical Hospital","Khimki",{"type":37,"coordinates":46},[47,48],37.42848,55.9001,{"lat":48,"lon":47},{"facility":51,"status":32,"city":52,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":53,"geoPoint":57,"contacts":10},"Kuban State Medical University","Krasnodar",{"type":37,"coordinates":54},[55,56],38.98178,45.04534,{"lat":56,"lon":55},{"facility":59,"status":32,"city":60,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":61,"geoPoint":65,"contacts":10},"Infectious Diseases Clinical Hospital No. 1","Moscow",{"type":37,"coordinates":62},[63,64],37.61781,55.75204,{"lat":64,"lon":63},{"facility":67,"status":32,"city":60,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":68,"geoPoint":70,"contacts":10},"Z.A. Bashlyaeva Children's City Clinical Hospital",{"type":37,"coordinates":69},[63,64],{"lat":64,"lon":63},{"facility":72,"status":32,"city":73,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":74,"geoPoint":78,"contacts":10},"Penza Regional Clinical Center for Specialized Types of Medical Care","Penza",{"type":37,"coordinates":75},[76,77],45.01075,53.19568,{"lat":77,"lon":76},{"facility":80,"status":32,"city":81,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":82,"geoPoint":86,"contacts":10},"Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency","Saint Petersburg",{"type":37,"coordinates":83},[84,85],30.31413,59.93863,{"lat":85,"lon":84},{"facility":88,"status":32,"city":89,"state":10,"zip":10,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":96,"contacts":10},"Samarkand State Medical University","Samarkand","Uzbekistan","UZ",{"type":37,"coordinates":93},[94,95],66.96445,39.65456,{"lat":95,"lon":94},{"type":98,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100598057","trial-of-the-efficacy-and-safety-of-use-of-drug-product-reamberin-for-pathogenetic-therapy-of-viral-enteric-infection-in-children-aged-1-6-years-old-100598057",false,"NCT07066540","Trial of the Efficacy and Safety of Use of Drug Product Reamberin® for Pathogenetic Therapy of Viral Enteric Infection in Children Aged 1-6 Years Old","Open Multicenter Prospective Observational Trial of the Efficacy and Safety of Use of Drug Product Reamberin® Solution for Infusion, 1.5 % (Scientific Technological Pharmaceutical Firm \"POLYSAN\") for Pathogenetic Therapy of Viral Enteric Infection in Children Aged 1-6 Years Old","Inclusion Criteria:\n\n1. Children of both sexes at the age of 1 to 6 years old inclusive;\n2. Diagnosis \"Viral and other specified intestinal infections\" (code according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision(ICD-10): A08),\n3. Clinical signs of endogenous intoxication (nausea, vomiting, hyperthermia, headache, muscle pain, asthenia, adynamia, etc.);\n4. Indication for parenteral rehydratation (infusion therapy);\n5. Decision of a physician on prescribing drug product Reamberin® solution for infusion, 1.5 % (Scientific Technological Pharmaceutical Firm \"POLYSAN\") in the daily dose of 10 mL\u002Fkg and normal saline NaCl\u002F5 % or 10 % solution of glucose or normal saline NaCl\u002FRinger's solution\u002F5 % or 10 % solution of glucose;\n6. To confirm the diagnosis by laboratory tests, biological material was taken;\n7. Informed Consent Form on Participation in the Observational Program signed and dated by a parent\u002Flegal representative of the patient.\n\nExclusion Criteria:\n\n1. Individual intolerance or known hypersensitivity to sodium meglumine, sodium succinate, and\u002For normal saline (NaCl), solution of glucose, Ringer's solution or excipients of drug product Reamberin® based on data of medical history;\n2. Contraindications to prescription of drug product Reamberin®;\n3. Necessity in surgical interventions during the observational program;\n4. Patients previously enrolled in this trial but discontinued participation due to any any reason;\n5. Administration of antibiotics or succinate-containing drug products (Cytoflavin, Mexidol, etc.) and solutions containing malate;\n6. Other conditions that, according to the Investigator, prevent enrollment of a patient into the observational trial or can result in premature discontinuation of the observational trial by the patient","ALL","1 Year","6 Years",{"count":110,"type":111},300,"ESTIMATED","OBSERVATIONAL","To assess the efficacy and safety of use of drug product Reamberin® solution for infusion, 1.5 % (Scientific Technological Pharmaceutical Firm \"POLYSAN\") for pathogenetic therapy of viral enteric infection in children aged 1-6 years old in routine clinical practice. Trial population: children of both sexes at the age of 1-6 years old inclusive with viral enteric infection.",[115],"Viral Enteric Infection",[117,118],"viral enteric infection","reamberin","2025-07-12",{"date":121,"type":122},"2025-07-15","ACTUAL",{"date":124,"type":122},"2024-08-01",{"date":126,"type":111},"2026-12",{"name":5,"class":6},8]