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IRCT20210822052256N1 IRCT 2021-10-27 Esfahan University of Medical Sciences Comparison of the effect of Venlafaxine and Oxybutynin in the Treatment of Hot Flashes A comparative study of the effect of Venlafaxine and Oxybutynin in controlling Hot Flashes in patients with Breast Cancer 2021-11-11 anticipated 64 Complete https://irct.ir/trial/59435 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients participating in the study will be divided into two groups getting Oxybutynin or Venlafaxine; using a Random Number Table, Blinding description: Participants in this study will be divided into two groups receiving oxybutynin or venlafaxine, and patients in each group will receive one tablet per day, which will be in the same container and without the name and specifications of the Drug, without knowing the type of Drug. Participants in the study, the Main Researcher, the Clinical Evaluator and the Statistical analyst of the study will not know how patients are placed in the groups receiving Venlafaxine or Oxybutynin. 2 Breast Cancer. Intervention 1: Intervention group: Venlafaxine 37.5 mg tablets one tablet per day for 8 weeks Product of Loghman Pharmaceutical Company. Intervention 2: Intervention group: Oxybutynin 10 mg tablets, one tablet per day for 8 weeks, produced by Exir Pharmaceutical Company. 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 There is no more information
public Ali Akhavan
Radiation Oncology Department, Seyed-alshohada (Omid) Hospital, Motahari Ave.,
Isfahan Iran (Islamic Republic of) 8184917911 +98 31 3235 0210 aliakhavan@med.mui.ac.ir Esfahan University of Medical Sciences scientific Ali Akhavan
Radiation Oncology Department, Seyed-alshohada (Omid) Hospital, Motahari Ave.,
Isfahan Iran (Islamic Republic of) 8184917911 +98 31 3235 0210 aliakhavan@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 18 years or older Pre-menopause At least 6 months have passed since the last Menstrual Period. Hot Flashes attacks Willingness to participate in the study 18 years no limit Female Uncontrolled Hypertension Chronic Heart Failure Chronic Kidney Disease Chronic Lung Failure Chronic Liver Failure Pregnancy Breast feeding Taking Anti Depressant Drugs Taking other Medications to control Hot Flashes over the past Two weeks C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Intervention group: Venlafaxine 37.5 mg tablets one tablet per day for 8 weeks Product of Loghman Pharmaceutical Company Intervention group: Oxybutynin 10 mg tablets, one tablet per day for 8 weeks, produced by Exir Pharmaceutical Company Severity of Hot Flashes. Timepoint: At the beginning of the study and 8 weeks after taking Venlafaxine or Oxybutynin. Method of measurement: Check List. Esfahan University of Medical Sciences Approved 2021-09-10 Research Ethics Committees of School of Medicine-Isfahan University of Medical Sciences Hezar jarib Ave, Isfahan University of Medical Sciense Isfahan Isfehan Iran (Islamic Republic of)