Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia (ALOE-DUTA-BPH)

Universitas Diponegoro

Status and phase: Enrolling; Phase 1

Conditions: BPH (Benign Prostatic Hyperplasia)

Treatments: Drug: Dutasteride (0.5mg); Drug: Aloevera + dutasteride

Study type: Interventional

Funder types: Other

Identifiers

NCT07065682

22010119510006

Details and patient eligibility

About

This study is a double blinded RCT with pre-post test design on the effect of combination of dutasteride and aloe vera, compared to dutasteride only, on uroflowmetry results, prostate volume, and VEGF serum level among patients with benign prostate hyperplasia. The treatment was given for 12 weeks

Enrollment: 84 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with BPH clinically or radiologically (prostate volume > 30 gram, Qmax <15 mL/s)
• Willing to participate to the study

Exclusion criteria

• Clinically or radiologically suspected of having prostatic cancer
• Previous prostatic surgery
• Patients with urinary retention
• Patients with BPH complications: urinary tract infections, urolithiasis, or hydroneprhosis
• Previously consumed alpha blocker or 5ARI in the last 6 months
• Have consumed aloe vera extract routinely

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

Dutasteride 0,5 mg/day + Aloe Vera Extract 380 mg/day

Experimental group

Treatment:

Drug: Aloevera + dutasteride

Dutasteride

Active Comparator group

Description:

Control

Treatment:

Drug: Dutasteride (0.5mg)