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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2027-12-01

Brief Summary

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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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Detailed Description

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Conditions

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BPH (Benign Prostatic Hyperplasia)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

Aloevera + dutasteride

Intervention Type DRUG

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

Dutasteride

Control

Group Type ACTIVE_COMPARATOR

Dutasteride (0.5mg)

Intervention Type DRUG

Control

Interventions

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Aloevera + dutasteride

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

Intervention Type DRUG

Dutasteride (0.5mg)

Control

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No