]>
IRCT20120516009772N2 IRCT 2021-01-18 Shahid Beheshti University of Medical Sciences Effect of finastride/ dutastride accompanying with tamsulosin in treatment of Benign prostate hyperplasia The Efficacy and side effects of different doses of finastride/ dutastride accompanying with tamsulosin for Benign prostate hyperplasia in Iranian men 2019-09-22 anticipated 175 Complete https://irct.ir/trial/49242 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization method will be used. Five labels of treatment groups will be inserted in an excel file orderly and in the corresponding column, random numbers will be produced. By sorting the random numbers, the order of labels will randomly change. This randomized file will be used for the samples and cases who enrolled into our study and they will be grouped based on labels in the file, Blinding description: تاThis is a multicenter, randomized , double blind, parallel group study.the Patients are randomised to 5 groups (discussed previously). Tamsulosin 0.4 mg is given to all participants .The finastride 5mg and 3mg , dutastride 0.5mg and 0.25mg and placebo tablets are identical in appearance and prepared by tansnim company . five treatment groups are labeled as A,B,C,D ,E by one of our collogues who is not care provider or assessor or data analyzer and each code represents one group and keep from the care provider and participants and assessor and data analyser until end of study. care provider and participants and data analyzer and outcome assessor are all blinded .Patients are assessed at visit 1 (screening visit) and If eligible, the patients will start in the double-blind study period where visits take place at weeks 4, 12, 24. a general physician who care for participants during trial is blinded in our study. 3 medical treatment of benign prostate hyperplasia. Intervention 1: Control group: patients with benign prostate hyperplasia take tamsulosin 0.4 mg (made by tasnim company)and placebo(made by tasnim company) daily for six months. Intervention 2: Intervention group: patients with benign prostate hyperplasia take tamsulosin 0.4 mg and finastride 5 mg daily for six months (tamsulosin and finastride 5 mg made by tasnim company). Intervention 3: intervention group: patients with benign prostate hyperplasia take tamsulosin 0.4 mg and finastride 3 mg daily for six months (tamsulosin and finastride 5 mg made by tasnim company). Intervention 4: Intervention group: patients with benign prostate hyperplasia take tamsulosin 0.4 mg and dutastride 0.5 mg daily for six months (tamsulosin and dutastrude 0.5 made by tasnim company). Intervention 5: Intervention group: patients with benign prostate hyperplasia take tamsulosin 0.4 mg and dutastride 0.25 mg daily for six months(tamsulosin and dutastrude 0.25 mg made by tasnim company). Yes - There is a plan to make this available What will be shared: IPD collected for the primary and secondary outcome When: when summary data are published To whom: for people working in academic institutions Conditions: 1- a new clinical trial is scheduled 2- affiliation of our center should be used Where to obtain: amirezabedi@gmail.com How to obtain: email Comments:
public Amir Reza Abedi
Tajrish square, shohada-e tajrish hospital
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8014 amirezabedi@gmail.com Shahid Beheshti University of Medical Sciences scientific amir Reza Abedi
Tajrish suare, shohada-e tajrish hospital
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8014 amirezabedi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) prostate size larger than 30 gram moderate to sever symptom (ipss>13) older than 55 years old Qmax of 4–15 mL/s from a pre-void bladder volume ≥150 and ≤550 mL (minimum voided volume 125 mL) with >6 months history of BPH-LUTS 55 years 75 years Male no surgical indication(bladder stone,uremia,urinary retention,gross hematuria,recurrent infection) no previous prostate surgery no urethral stricture PSA>4 history of severe renal or hepatic insufficiency History of bladder cancer or prostate cancer D29.1 Benign neoplasm of prostate Placebo Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: patients with benign prostate hyperplasia take tamsulosin 0.4 mg (made by tasnim company)and placebo(made by tasnim company) daily for six months. Intervention group: patients with benign prostate hyperplasia take tamsulosin 0.4 mg and finastride 5 mg daily for six months (tamsulosin and finastride 5 mg made by tasnim company) intervention group: patients with benign prostate hyperplasia take tamsulosin 0.4 mg and finastride 3 mg daily for six months (tamsulosin and finastride 5 mg made by tasnim company) Intervention group: patients with benign prostate hyperplasia take tamsulosin 0.4 mg and dutastride 0.5 mg daily for six months (tamsulosin and dutastrude 0.5 made by tasnim company) Intervention group: patients with benign prostate hyperplasia take tamsulosin 0.4 mg and dutastride 0.25 mg daily for six months(tamsulosin and dutastrude 0.25 mg made by tasnim company) The comparison of the maximum flow rate (qmax) before , 3 and 6 moths after treatment in each group and among 5 groups under this study. Timepoint: before treatment and 3 ,6 months after treatment. Method of measurement: uroflowmetry. The comparison of international prostate symptom score before, 3 and 6 months of treatment in each group and among 5 groups under treatment. Timepoint: before treatment ,3 and 6 months after tretment. Method of measurement: questionnaire. The comparison of IIEF15 before ,3 and 6 months after treatment in each group among 5 groups under study. Timepoint: before treatment, 3 and 6 months after treatment. Method of measurement: IIEF15 Questionnaire. The comparison of complication after treatment among five groups under study. Timepoint: 3 and 6 months after treatment. Method of measurement: questionnaire. Tandis company Approved 2020-11-01 ethics committee of shahid beheshti university of medical sciences, urology and nephrology research urology and nephrology research center,NO 103,ninth bustan(jafari ),pasdaran avenue,tehran,iran Tehran Tehran Iran (Islamic Republic of)