Research on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia
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).
Inclusion Criteria:

 -  Males aged >=40 years old

 -  Screened by inquiry and diagnosed as BPH based on the result of a digital rectal
 examination (DRE) or transrectal ultrasonography (TRUS)

 -  Prostate volume >= 20 cm3

 -  Has complained of voiding symptoms related to BPH

 -  Has an IPSS >= 13 or an UFR measure of Qmax <= 15 ml/sec together with a voided volume
 >= 150 ml.

 -  Serum PSA < 6.5 ng/ml

 -  Has been treated with medication for BPH

 -  Informed consent form signed.

 Exclusion Criteria:

 -  Sensitivity to study product

 -  Had received prostatic surgery for BPH during the past 24 weeks

 -  Hard nodule found by DRE

 -  Ongoing neurogenic bladder, urinary tract infection, bladder stone, urethral
 stricture, bladder cancer, prostate cancer, severe liver dysfunction, severe renal
 dysfunction or severe cardiovascular disease.

 -  Patient has clinically significant physical disability or abnormal findings on
 physical examination or laboratory testing judged by the investigator or co-
 investigator.

 -  Participation of any clinical investigation during the last 30 days.

 -  Individuals are judged by the investigators or co- investigator to be undesirable as
 subjects.