Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia
ALOE-DUTA-BPH
1 other identifier
interventional
84
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2023
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 3, 2025
CompletedFirst Posted
Study publicly available on registry
July 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedJuly 15, 2025
July 1, 2025
1.4 years
July 3, 2025
July 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Uroflowmetry result
Qmax of Uroflowmetry result
12 weeks
Secondary Outcomes (2)
Prostatic volume
12 weeks
VEGF
12 weeks
Study Arms (2)
Dutasteride 0,5 mg/day + Aloe Vera Extract 380 mg/day
EXPERIMENTALDutasteride
ACTIVE COMPARATORControl
Interventions
Dutasteride 0,5 mg/day + Aloe Vera Extract 380 mg/day
Eligibility Criteria
You may qualify if:
- Diagnosed with BPH clinically or radiologically (prostate volume \> 30 gram, Qmax \<15 mL/s)
- Willing to participate to the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
RSUD Karawang
Karawang, West Java, Indonesia
Related Publications (1)
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
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Achmad Rizky Herda Pratama dr. Achmad Rizky Herda Pratama, Sp.U, S.H, Urologist
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dr. Achmad Rizky Herda Pratama, Sp.U, S.H.
Study Record Dates
First Submitted
July 3, 2025
First Posted
July 15, 2025
Study Start
July 1, 2023
Primary Completion
December 1, 2024
Study Completion (Estimated)
December 1, 2027
Last Updated
July 15, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share