Benign Prostatic Hyperplasia Clinical Trial
Official title:
Research on Benefit of Umooze as Add-on Therapy in Benign Prostatic Hyperplasia
To evaluate the improvement in symptoms of Benign Prostatic Hyperplasia (BPH) according to the Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of Umooze twice daily administration for 56 days in patients with BPH.
The study product, Umooze, contain Astragalus radix extracts and Soy extracts as the
combination of 960:40 in one 500 mg tablet. Umooze is sold in the market as food. The
objective of this study is to evaluate the benefit of Umooze as add- on therapy in BPH, by
evaluation the improvement in symptoms of BPH assessed according to the International
Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of
Umooze in patients with BPH. The IPSS is a validated 7-item urinary symptom severity scale.
A randomized, two-regimen, placebo-controlled, parallel- design is used in this study in
which each subject will receive Umooze or placebo. The add- on study product will be
administered twice daily for 56 days. Benefit will be evaluated at baseline and subsequently
on the study day 28, 42, and 56, such as IPSS index, QoL index, Qmax, PVR, prostate volume
and Prostate-specific antigen(PSA).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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