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IRCT20120215009014N332 IRCT 2020-01-11 Hamedan University of Medical Sciences Effect of zinc supplementation versus control group on cellular immunity, treatment and relapse of brucellosis Effect of zinc supplementation versus control group on cellular immunity, treatment, and relapse of brucellosis: a single-blind randomized clinical trial 2020-03-05 anticipated 80 Complete https://irct.ir/trial/44887 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The drugs will be given in coded envelopes. Therefore, patients will be unaware of the type of intervention. Thus, the trial will be run as single-blind. 2 Brucellosis. Intervention 1: Intervention group: Routine treatment brucellosis plus Zinc gluconate tablet (manufactured by Darukadeh Pharmaciutical Co.) 30 mg daily for 8 weeks. Intervention 2: Control group: Routine treatment brucellosis. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situations and the results of the study as well as the approval of the financial supporting organization.
public Dr. Fariba Keramat
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 faribakeramat@yahoo.com Hamedan University of Medical Sciences scientific Dr. Fariba Keramat
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 faribakeramat@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 15 to 60 years, Acute brucellosis 15 years 60 years Both Pregnancy, History of brucellosis, Complicated brucellosis, Chronic diseases such as cardiovascular disease, anemia, bone carcinoma, Concurrent with AIDS, A history of collagen vascular disease, A history of zinc use A23 Brucellosis Treatment - Drugs Treatment - Drugs Intervention group: Routine treatment brucellosis plus Zinc gluconate tablet (manufactured by Darukadeh Pharmaciutical Co.) 30 mg daily for 8 weeks Control group: Routine treatment brucellosis Clinical symptoms. Timepoint: Before the intervention and 1 and 2 months later. Method of measurement: By taking history and physical examination. Treatment of the disease. Timepoint: 1 and 2 months after the intervention. Method of measurement: by using 2ME test. Relapse of the disease. Timepoint: 6 months after the intervention. Method of measurement: by using 2ME test. Hamedan University of Medical Sciences Approved 2019-12-21 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)