Research on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Umooze	Umooze	Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extracts 20 mg
Placebo	Placebo	Cornstarch.

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months	56 days	It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.
Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge	56 days	The Quality of Life (QoL) is a single question with scores of 0\~6 point and corresponding to the assessment index ranging from delighted to terrible.
International Prostate Symptom Score (IPSS)	56 days	It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.
Quality- Of- Life Index (QoL)	56 days	The QoL index is a single question with scores of 0\~6 point and corresponding to the assessment index ranging from delighted to terrible.

Secondary Outcome Measures

Name	Time	Method
Postvoid Residual Volume (PVR)	56 days	The PVR urine test measures the amount of urine left in the bladder after urination.
Prostate Volume	56 days	It's related to progression of benign prostatic hyperplasia (BPH).
Prostate-specific Antigen (PSA) Level	56 days	Serum PSA test measures the amount of prostate- specific antigen in the blood. As a man's prostate enlarges with age, the amount of PSA in the blood normally increases.
Maximum Flow Rate (Qmax)	56 days	It's used to determine the degree of urinary difficulty.