Dutasteride plus aloe vera to improve urine flow and reduce prostate enlargement in men with BPH
Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia
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 |
| Enrollment | 84 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Universitas Diponegoro Academic / other |
| Locations | 1 site (Karawang, West Java) |
| Trial ID | NCT07065682 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Karawang, West Java
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.