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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age50+
SponsorUniversitas Diponegoro

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with BPH clinically or radiologically (prostate volume > 30 gram, Qmax <15 mL/s)

Willing to participate to the study

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Aloevera + dutasteride

    Drug

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

  • Dutasteride (0.5mg)

    Drug

    Control

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Dutasteride 0,5 mg/day + Aloe Vera Extract 380 mg/dayExperimental treatment 1 intervention
Group B: DutasterideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Uroflowmetry result

Qmax of Uroflowmetry result

Time frame
12 weeks

Secondary outcomes

1

Prostatic volume

Measured by transabdominal ultrasonography

Time frame
12 weeks
2

VEGF

serum VEGF level

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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