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IRCT201406299014N37 IRCT 2014-07-04 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences The effect of hydroxychloroquine versus standard drug therapy on the treatment and recurrence of brucellosis The effect of hydroxychloroquine versus standard drug therapy on the treatment and recurrence of brucellosis: a single blinded randomized clinical trial 2014-07-23 anticipated 176 Other https://irct.ir/trial/9476 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: Using balance block randomization with group f four so that every four patents will be randomly assigned to intervention and control groups. This process will be continued until to reach the sample size. Blinding: The patients will not aware of the type of treatment they will receive but the physician who will examine the patents will be aware of the type of treatment. Therefore, the trial will be run as single blinded. 2 Brucellosis. Intervention 1: oral hydroxychloroquine 400 mg daily for two months plus standard drug therapy for brucellosis. Intervention 2: only standard drug therapy for brucellosis.
public Dr Mohammad Mahdi Majzoobi
Farshchian Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) +98 81 3838 0717 mahdi.majzoobi@umsha.ac.ir Farshchian Hospital scientific Dr Mohammad Mahdi Majzoobi
Farshchian Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) +98 81 3838 0717 mahdi.majzoobi@umsha.ac.ir Farshchian Hospital Iran (Islamic Republic of) Inclusion criteria: (a) patients with sign and symptoms of brucellosis have Wright test of more than 1/160 and 2ME titer more than 1/80; (b) patients with chronic brucellosis who did not responded to standard drug therapy with constant or increased 2ME titer; (c) age of 18 years or older. Exclusion criteria: (a) being pregnant; (b) having history of porphyria, psoriasis, degenerative macula, hemolytic diseases, gastrointestinal diseases, neurologic diseases, and G6PD deficiency. 18 years 80 years Both A23 Brucellosis Treatment - Drugs Other oral hydroxychloroquine 400 mg daily for two months plus standard drug therapy for brucellosis only standard drug therapy for brucellosis Response to treatment. Timepoint: before treatment and 1, 2, 3, and 5 months later. Method of measurement: based on 2ME titer. Incidence of probable adverse effects such as hepatitis and visual impairment. Timepoint: at 1, 2, 3, and 5 months after treatment. Method of measurement: through history taking and physical examination. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2014-05-17 Research Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)