Dutasteride plus aloe vera to improve urine flow and reduce prostate enlargement in men with BPH
Official title: Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia
Run by Universitas Diponegoro · NCT07065682 · Data updated 2026-11-12
This trial tests whether adding aloe vera extract to dutasteride helps men with enlarged prostates (BPH) improve urine flow, reduce prostate size, and lower VEGF blood levels over 12 weeks.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years and up |
| Sex | Men only |
| Enrollment | 84 (estimated) |
| Sponsor | Universitas Diponegoro Academic / other |
| Locations | 1 site (Karawang, West Java) |
| Status | Recruiting |
| Started | July 1, 2023 |
| Main results expected | December 1, 2024 |
| Study ends | December 1, 2027 |
| Registry record updated | July 15, 2025 |
| Trial ID | NCT07065682 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men with clinically or radiologically confirmed BPH (prostate volume >30 g or Qmax <15 mL/s) who are willing to participate and have not recently used alpha blockers, 5-ARIs, or routine aloe vera are ideal candidates.
✕Probably not a fit
Patients with suspected prostate cancer, prior prostate surgery, urinary retention, active BPH complications, recent alpha blocker/5-ARI use, or regular aloe vera use were excluded and are unlikely to be helped by this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a double-blind, randomized controlled Phase 1 trial comparing a combination of dutasteride plus aloe vera extract versus dutasteride alone with measurements taken before and after 12 weeks of treatment. Primary outcomes include uroflowmetry (Qmax), prostate volume, and serum VEGF level. Eligible participants are men with clinically or radiologically confirmed BPH who have not used alpha blockers or 5-ARIs in the prior six months and who do not have complicating conditions such as urinary retention or suspected prostate cancer. The intervention is administered at a single center and blinded to participants and investigators to reduce bias.
Why it matters
Potential benefit: If successful, the combination could improve urinary flow and reduce prostate size and inflammation markers more than dutasteride alone.
How similar studies have gone: Dutasteride is an established BPH treatment, but using aloe vera as an add-on is experimental and has limited clinical evidence, so this combination is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
RSUD Karawang
Karawang, West Java, Indonesia Recruiting
Study contacts
- Study coordinator: Achmad Rizky Herda Pratama dr. Achmad Rizky Herda Pratama, Sp.U, S.H, Urologist
- Email: herdapratama@gmail.com
- Phone: +6282184801976
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.