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IRCT20181128041777N1 IRCT 2019-03-14 Tabriz University of Medical Sciences Effect of Carvedilole compared to Terazosin plus Enalapril in treatment of Hypertension and benign prostatic hyperplasia Effect of Carvedilole and combination of Terazosin plus Enalapril on blood pressure and urinary symptoms among patients with Hypertension and Benign Prostatic Hyperplasia 2018-12-22 anticipated 40 Complete https://irct.ir/trial/35527 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: block, simple randomization. 3 Condition 1: Hypertension. Condition 2: Benign prostate hyperplasia. Intervention 1: Intervention group 1: After random allocation in 2 groups, first group was treated with Carvedilol, produced by SOHA company, 12.5 mg (Max 25 mg) and Blood pressure was kept in normal range (120 over 80 mmHg). Tab VitB complex-DP was used as placebo. Prostate examination, recording urinary symptoms and blood pressure control were done every month. Treatment period was 12 weeks and after that there was a 12-week wash out period with blood pressure checking every month. Then this group was treated with terazosin produced by ARYA company, 5 mg up to 20 mg and enalapril produced by SOBHAN company, 2.5 mg max 20 mg to achieve normal blood pressure. Examinations and blood pressure recording were done every month. Treatment periods were 12 weeks. Intervention 2: Intervention group 2 received terazosin, produced by ARYA company, 5 mg up to 20 mg and enalapril, produced by SOBHAN company, 2.5 mg max 20 mg to control blood pressure in normal range. Treatment period was 12 weeks and after that there was a 12-week wash out period with blood pressure checking every month. Then this group received carvedilol, produced by SOHA company, 12.5 mg max 25 mg with Vitamin-B complex DP as placebo. Blood pressure and prostate examination was done each month. Treatment period was 12 weeks. Yes - There is a plan to make this available What will be shared: All data without patients' name can be accessible through email. When: accessible after publication on 2019 To whom: all researchers Conditions: after written permission of author Where to obtain: Tabriz university of medical science http://pazhoohan.tbzmed.ac.ir How to obtain: accessible after email on Tabriz university of medical science site Comments: 0
public Nooriyeh Dalir Akbari
Shahriar Ave. Golcar Blvd. Aref Town.No 15
Tabriz Iran (Islamic Republic of) 5156954567 +98 41 3335 9633 info@imamreza.tbzmed.ac.ir Tabriz University of Medical Sciences scientific Nooriyeh Dalir akbari
No 15, Aref Town, GolKar Blvd, Shahriar street
Tabriz Iran (Islamic Republic of) 5156954567 +98 41 3335 9633 info@imamreza.tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Moderate hypertension (according European guide line blood pressure between 140-159 in systolic and 90-99 in diastolic) Men above 40 years with benign prostatic hyperplasia that diagnosis with permanent LUTS during the last 6 months ,physical examination, ultrasonography and serum PSA 40 years no limit Male History of using alfa blockers during the last 6 months history of uncontrolled or malignant urgency HTN history of using anti hypertensive and prostate drugs history of prostate cancer history of prostate surgery I10 N40.1 Essential (primary) hypertension Enlarged prostate with lower urinary tract symptoms Treatment - Drugs Treatment - Drugs Intervention group 1: After random allocation in 2 groups, first group was treated with Carvedilol, produced by SOHA company, 12.5 mg (Max 25 mg) and Blood pressure was kept in normal range (120 over 80 mmHg). Tab VitB complex-DP was used as placebo. Prostate examination, recording urinary symptoms and blood pressure control were done every month. Treatment period was 12 weeks and after that there was a 12-week wash out period with blood pressure checking every month. Then this group was treated with terazosin produced by ARYA company, 5 mg up to 20 mg and enalapril produced by SOBHAN company, 2.5 mg max 20 mg to achieve normal blood pressure. Examinations and blood pressure recording were done every month. Treatment periods were 12 weeks. Intervention group 2 received terazosin, produced by ARYA company, 5 mg up to 20 mg and enalapril, produced by SOBHAN company, 2.5 mg max 20 mg to control blood pressure in normal range. Treatment period was 12 weeks and after that there was a 12-week wash out period with blood pressure checking every month. Then this group received carvedilol, produced by SOHA company, 12.5 mg max 25 mg with Vitamin-B complex DP as placebo. Blood pressure and prostate examination was done each month. Treatment period was 12 weeks. Q max: Maximum urinary flow rate show in uroflowmetry. Timepoint: in 4 time: before treatment. after carvedilol. before enalapril and terazosin and after that. Method of measurement: uroflowmetry. PVR :Post Voiding Residual. Timepoint: in 4 time: before treatment. after carvedilol. before enalapril and terazosin and after that. Method of measurement: Sonography. IPSS : international prostate symptom score. Timepoint: in 4 time: before treatment. after carvedilol. before enalapril and terazosin and after that. Method of measurement: International prostate symptom score questionnaire. PSA : prostate specific antigen. Timepoint: in 4 time: before treatment. after carvedilol. before enalapril and terazosin and after that. Method of measurement: Blood test. Systolic blood pressure. Timepoint: in 4 time: before treatment. after carvedilol. before enalapril and terazosin and after that. Method of measurement: mercury manometer. Diastolic blood pressure. Timepoint: in 4 time: before treatment. after carvedilol. before enalapril and terazosin and after that. Method of measurement: mercury manometer. Tabriz University of Medical Sciences Approved 2018-08-26 Ethics committee of Tabriz University of Medical Sciences central building of Tabriz University of Medical Sciences, Golgasht avenue, Azadi street Tabriz East Azarbaijan Iran (Islamic Republic of)