[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550822":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":43,"responsibleParty":124,"collaborators":126,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":37,"eligibilityCriteria":136,"healthyVolunteers":132,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":37,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":152,"whyStopped":37,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Biodex S.A","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","Group 1: (n=140) Investigational Product 10 ml, drinkable ampoule (1 ampoule) (1 time only)",[13],"Other: IMMUNO19",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2","PLACEBO_COMPARATOR","Group 2: (n=140) Placebo 10 ml (1 ampoule) (1 time only)",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"OTHER","IMMUNO19","280 participants will be divided into 2 groups. There will be 140 participants in the groups.\n\nThe 1st group will receive IMMUNO19 10 mL one time, The 2nd group will receive Placebo 10 mL for one time.",[9,15],[26],"Essential Oils Combination",[28],{"name":29,"affiliation":30,"role":31},"Kanat Tayfun, MD","Bagcilar Training and Research Hospital","PRINCIPAL_INVESTIGATOR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Mounir Bezzarga","CONTACT","+216 98 362260",null,"mounir.bezzarga@yahoo.fr",{"name":40,"role":35,"phone":41,"phoneExt":37,"email":42},"İklim Turkoz","+90 543 259 59 40","iklim.turkoz@gamacro.com",[44,56,63,73,80,87,97,104,111,117],{"facility":45,"status":37,"city":46,"state":47,"zip":48,"country":49,"countryCode":37,"cosmosGeoPoint":50,"geoPoint":55,"contacts":37},"Bağcılar Training and Research Hospital","Istanbul","Bagcılar","34212","Turkey (Türkiye)",{"type":51,"coordinates":52},"Point",[53,54],28.94966,41.01384,{"lat":54,"lon":53},{"facility":57,"status":37,"city":46,"state":58,"zip":59,"country":49,"countryCode":37,"cosmosGeoPoint":60,"geoPoint":62,"contacts":37},"Gaziosmanpaşa Training and Research Hospital","Gaziosmanpaşa","34255",{"type":51,"coordinates":61},[53,54],{"lat":54,"lon":53},{"facility":64,"status":37,"city":65,"state":66,"zip":67,"country":49,"countryCode":37,"cosmosGeoPoint":68,"geoPoint":72,"contacts":37},"Kocaeli City Hospital","Kocaeli","İzmit","41060",{"type":51,"coordinates":69},[70,71],27.51145,39.62497,{"lat":71,"lon":70},{"facility":74,"status":37,"city":46,"state":75,"zip":76,"country":49,"countryCode":37,"cosmosGeoPoint":77,"geoPoint":79,"contacts":37},"Göztepe Süleyman Yalçın City Hospital","Kadıköy","34722",{"type":51,"coordinates":78},[53,54],{"lat":54,"lon":53},{"facility":81,"status":37,"city":46,"state":82,"zip":83,"country":49,"countryCode":37,"cosmosGeoPoint":84,"geoPoint":86,"contacts":37},"Kartal Dr. Lütfi Kırdar City Hospital","Kartal","34865",{"type":51,"coordinates":85},[53,54],{"lat":54,"lon":53},{"facility":88,"status":37,"city":89,"state":90,"zip":91,"country":49,"countryCode":37,"cosmosGeoPoint":92,"geoPoint":96,"contacts":37},"Akdeniz University","Antalya","Konyaaltı","07070",{"type":51,"coordinates":93},[94,95],30.69556,36.90812,{"lat":95,"lon":94},{"facility":98,"status":37,"city":46,"state":99,"zip":100,"country":49,"countryCode":37,"cosmosGeoPoint":101,"geoPoint":103,"contacts":37},"Süreyyapaşa Chest Disease and Thoracic Surgery Training and Research Hospital","Maltepe","34844",{"type":51,"coordinates":102},[53,54],{"lat":54,"lon":53},{"facility":105,"status":37,"city":46,"state":106,"zip":107,"country":49,"countryCode":37,"cosmosGeoPoint":108,"geoPoint":110,"contacts":37},"Umraniye Training and Research Hospital","Umraniye","34764",{"type":51,"coordinates":109},[53,54],{"lat":54,"lon":53},{"facility":112,"status":37,"city":89,"state":37,"zip":113,"country":49,"countryCode":37,"cosmosGeoPoint":114,"geoPoint":116,"contacts":37},"Antalya Atatürk Public Hospital","07040",{"type":51,"coordinates":115},[94,95],{"lat":95,"lon":94},{"facility":118,"status":37,"city":46,"state":119,"zip":120,"country":49,"countryCode":37,"cosmosGeoPoint":121,"geoPoint":123,"contacts":37},"Cemil Taşcıoğlu City Hospital","Şişli","34384",{"type":51,"coordinates":122},[53,54],{"lat":54,"lon":53},{"type":125,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[127],{"name":128,"class":129},"Gama CRO Tıbbi IIac Arastirma Org.Tic.Ltd.Sti","UNKNOWN","100550822","efficacy-and-safety-study-of-essential-oil-based-preparation-administered-to-covid-19-patients-100550822",false,"NCT06452069","Efficacy and Safety Study of Essential Oil-Based Preparation Administered to COVID-19 Patients","A Multicentre, Randomised, Prospective Study Investigating the Efficacy and Safety of an Essential Oil-Based Preparation Administered to Mild and Moderately Severe COVID-19 Positive Patients","Inclusion Criteria:\n\n* Patients must be between 18\\\u003CX\\\u003C 65 years of age.\n* The participant must be willing and able to give written informed consent. The volunteer must provide his\u002Fher consent on his or her behalf, a legally acceptable representative (i.e., an International Harmonization Council \\[ICH\\] and adopted by local law as appropriate can be used) must give informed consent on his\u002Fher behalf.\n* PCR test COVID-19 positive diagnosis and mild to moderate disease stage is required.\n* The participant must agree not to receive vaccines administered for COVID-19 during the study.\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years of age,\n* Positive diagnosis of severe COVID-19 with symptoms of basic severity: patients with respiratory distress, signs of mental confusion and impaired consciousness that develop depending on the severity of the stage of the disease,\n* Patients on active antiviral therapy,\n* Patients with creatine clearance \\\u003C 30 ml\u002Fmin and renal impairment,\n* NYHA III-IV, Stage D heart failure patients requiring frequent hospitalization,\n* Uncontrolled coagulopathy,\n* Patients with advanced liver failure,\n* Patients with active infections such as hepatitis B, hepatitis C and HIV, diseases requiring systemic treatment,\n* Patients with active malignancy and known history of cancer,\n* Those who do not have sufficient psychic state to disrupt working rounds,\n* Active drug users,\n* Known hypersensitivity and allergic reaction to the components of the preparation,\n* Current participation in another interventional treatment study with an investigational agent,\n* Recent use of the investigational product within 28 days of the first dose of the investigational product use or presence of a research device during screening,\n* Pregnant or breastfeeding women,\n* Patients who did not give written informed consent.","ALL","18 Years","65 Years",{"count":141,"type":142},280,"ESTIMATED","INTERVENTIONAL",[145],"NA","The aim of this study was to compare the efficacy and safety of the essential oil-based product in patients with mild to moderate symptomatic COVID-19 Positive infection confirmed by PCR. A computational simulation approach of the molecular interaction (binding) of the main components of essential oils exhibiting antiviral activity with known intracellular protein targets of SARS-CoV-2 (nsp5: Main Protease) was adopted as a rationale for this study. SARS-CoV-2, a single-stranded RNA virus, has four major structural proteins Spike (S), Membrane (M), Envelope glycoprotein (E) and Nucleocapsid (N) protein and non-structural proteins (nsp). These non-structural proteins, of which there are 16 in total in the genome of the virus, play key roles in the mechanisms of the virus life cycle, including replication, transcription, protein synthesis and modification of RNA. Main protease (Main protease, Mpro, 3CLpro), virus Since they are directly involved in the maturation of these nsp proteins, which have an important role in many mechanisms of the life cycle, they have been the target enzyme in the development of new antiviral drugs for the treatment of COVID-19. In this study, our main rationale is to investigate the effect of essential oils on nsp5: Main Protease enzyme activations.",[148,149],"COVID-19 Respiratory Infection","COVID-19",[151],"Essential Oil, antiviral, Main Protease, COVID 19","NOT_YET_RECRUITING","2024-06-11",{"date":155,"type":156},"2024-06-13","ACTUAL",{"date":158,"type":142},"2024-09-15",{"date":160,"type":142},"2025-09-15",{"name":5,"class":6},10]