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NCT Number: NCT07065682

Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia

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

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Key information

Conditions

BPH (Benign Prostatic Hyperplasia) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

RSUD Karawang

Karawang, West Java, Indonesia

Location status: Recruiting

Location contact

Achmad Rizky Herda Pratama dr. Achmad Rizky Herda Pratama, Sp.U, S.H, Urologist

CONTACT

[email protected]

+6282184801976

Achmad Rizky Herda Pratama dr. Achmad Rizky Herda Pratama, Sp.U, S.H, Urologist

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aloevera + dutasteride

Drug

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

Dutasteride (0.5mg)

Drug

Control

Primary outcomes

  1. Uroflowmetry result

    Time frame: 12 weeks

    Qmax of Uroflowmetry result

Secondary outcomes

  1. Prostatic volume

    Time frame: 12 weeks

    Measured by transabdominal ultrasonography

  2. VEGF

    Time frame: 12 weeks

    serum VEGF level

Study contacts

Contact information is provided by the study sponsor or research team.

Achmad Rizky Herda Pratama dr. Achmad Rizky Herda Pratama, Sp.U, S.H, Urologist

CONTACT

[email protected]

+6282184801976

Sponsors and collaborators

Lead sponsor

Universitas Diponegoro

Other

Registry information

Acronym: ALOE-DUTA-BPH

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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