Actively Recruiting
Effectiveness of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction in Benign Prostatic Hyperplasia
Led by Universitas Diponegoro · Updated on 2025-07-15
84
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of combining dutasteride and aloe vera extract compared to dutasteride alone in men with benign prostatic hyperplasia (BPH). This phase 1 randomized, double-blind controlled trial aims to study changes in urinary flow, prostate size, and blood levels of vascular endothelial growth factor (VEGF), a marker related to blood vessel formation, over a 12-week treatment period. Participants receive daily doses of either dutasteride 0.5 mg with aloe vera extract 380 mg or dutasteride 0.5 mg alone for 12 weeks. The trial includes a control group receiving only dutasteride. The study employs quadruple masking to ensure unbiased assessment of treatment effects. During the study, participants will undergo tests to measure urine flow, prostate volume, and serum VEGF levels at the start and after 12 weeks of treatment. The researchers will monitor these outcomes to assess the impact of the treatments on BPH symptoms and related biological markers. The total participation duration is 12 weeks.
CONDITIONS
Brief Title
Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with benign prostatic hyperplasia clinically or by imaging (prostate volume > 30 grams, maximum urine flow rate < 15 mL/s)
- Willing to participate in the study
You will not qualify if you...
- Suspected prostatic cancer clinically or by imaging
- Previous prostate surgery
- Urinary retention
- BPH complications such as urinary tract infections, kidney stones, or hydronephrosis
- Use of alpha blockers or 5-alpha reductase inhibitors in the last 6 months
- Routine use of aloe vera extract prior to the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive daily doses of Dutasteride with or without Aloe Vera Extract to assess effects on benign prostatic hyperplasia.
Visits at baseline and periodically during the 12 weeks
Trial Site Locations
Total: 1 location
1
RSUD Karawang
Karawang, West Java, Indonesia
Actively Recruiting
Research Team
A
Achmad Rizky Herda Pratama dr. Achmad Rizky Herda Pratama, Sp.U, S.H, Urologist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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