Recruiting NCT07065682
Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aloevera + dutasteride, Dutasteride (0.5mg).
- Who it may be relevant to
- Registry conditions: BPH (Benign Prostatic Hyperplasia). Basic parameters: from 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Drug Aloevera + dutasteride
Dutasteride 0,5 mg/day + Aloe Vera Extract 380 mg/day - Drug Dutasteride (0.5mg)
Control
Primary outcome measures
- Uroflowmetry result [Time frame: 12 weeks]
Secondary outcome measures (2)
- Prostatic volume [Time frame: 12 weeks]
- VEGF [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Indonesia · 1 center
- RSUD Karawang — Karawang
Publications
- Nugroho E, Azhar A, Gunadi E. Relationship between Prostate Volume and International Prostate Symptom Score (IPSS) Degree of Tamed Prostate Enlargement on Transabdominal Ultrasonography (TAUS) and Transrectal Ultrasonography (TRUS) Examination. Biomed J Indones. 2021;1(7):112-7
Identifiers
NCT: NCT07065682 · 22010119510006