[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100367822":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":26,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":26,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":26,"overallStatus":70,"whyStopped":26,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":26},{"fullName":5,"class":6},"Infan Industria Quimica Farmaceutica Nacional","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treated Group","EXPERIMENTAL","Active Group with 237 participants undergoing treatment with oral mastic (Schinus terebinthifolia Raddi), 1 tablet of 640 mg + 1 placebo capsule, once a day, for a period of 4 weeks",[13],"Drug: Oral Aroeira",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Comparator Group with 237 participants undergoing treatment with omeprazole, 1 20mg capsule + 1 placebo tablet, once a day, for a period of 4 weeks.",[19],"Drug: Omeprazole 20Mg Capsule",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Oral Aroeira","Active Group oral Aroeira (Schinus terebinthifolia Raddi), 1 tablet of 640 mg + 1 placebo capsule, once a day, for a period of 4 weeks.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Omeprazole 20Mg Capsule","Comparator Group omeprazole, 1 20mg capsule + 1 placebo tablet, once a day, for a period of 4 weeks.",[15],[32],{"name":33,"affiliation":34,"role":35},"Severino B Santos, PhD","Hospital Univeristário Oswaldo Cruz","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"JAN CARLO MORAIS OLIVEIRA B DELORENZ, PhD","CONTACT","11989780869","jancarlo@hebron.com.br",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":44},"Haliny Magalhães, Pharm. B.","haliny@hebron.com.br",{"type":46,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[48],{"name":49,"class":50},"Hospital Universitário Oswaldo Cruz","UNKNOWN","100367822","phase-3-efficacy-of-oral-aroeira-schinus-terebinthifolia-raddi-compared-to-omeprazole-in-dyspeppsia-100367822",false,"NCT04069286","EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolia Raddi) COMPARED TO OMEPRAZOLE IN DYSPEPPSIA","EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolia Raddi) COMPARED TO OMEPRAZOLE IN PARTICIPANTS DIAGNOSED WITH FUNCTIONAL DYSPEPPSIA: A RANDOMIZED AND DOUBLE-BLIND STUDY","To be eligible to participate in this study, an individual must meet all of the following criteria:\n\nReport of at least 1 of the 5 dyspeptic symptoms, with onset more than 6 months ago, with at least least 3 months in duration, according to the ROME IV Classification criteria:\n\n* Nausea;\n* Heartburn;\n* Epigastric pain;\n* Abdominal discomfort aggravated\u002Frelieved by meals;\n* Feeling of early satiety.\n\nManifestation of the desire to participate in the study in a free and informed manner.\n\nAge range between 18 and 80 years old;\n\nAbility and desire to use an acceptable method of contraception listed below during the study and until the last follow-up visit:\n\n* Women - condoms, oral, topical, injectable or implantable contraceptive medications, Intrauterine Devices (IUDs) with or without hormones and true abstinence that is aligned with the participant's preferred and usual lifestyle (periodic abstinence \\[e.g., methods of table, ovulation, symptothermic, post-ovulation\\], declaration of abstinence during the period of study or coitus interruptus are not acceptable methods of true abstinence).\n* Women - will be referred to a gynecologist for screening and better definition of the method;\n* Men - guidance on condom use.","ALL","18 Years","80 Years",{"count":62,"type":63},474,"ESTIMATED","INTERVENTIONAL",[66],"PHASE3","This is a prospective, randomized, double - blind study of 474 male and female volunteers with dyspeppsia diagnosed at the Oswaldo Cruz University Hospital Gastroenterology Outpatient Clinic from March 2025 to March 2027.\n\nHypothesis:\n\nAs a non-inferiority study, the hypothesis is that the use of oral Aroeira (Schinus terebinthifolia Raddi) for the treatment of participants diagnosed with functional dyspepsia efficacy not inferior to therapy based on the use of omeprazole.",[69],"Dyspepsia","NOT_YET_RECRUITING","2024-04-24",{"date":73,"type":74},"2024-04-29","ACTUAL",{"date":76,"type":63},"2025-03",{"date":78,"type":63},"2027-03",{"name":5,"class":6}]