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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Dietary Supplement: Umooze
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umooze<br>Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extracts 20 mg | Dietary Supplement: Umooze<br>* Umooze is consisted of Astragalus radix extracts and soy extracts. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia.<br>|
| Placebo Comparator: Placebo<br>Cornstarch. | Dietary Supplement: Placebo<br>* Placebo is consisted of cornstarch and is provided by by Golden Biotechnology Corp.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) | 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. | 56 days | 
| Quality- Of- Life Index (QoL) | The QoL index is a single question with scores of 0 6 point and corresponding to the assessment index ranging from delighted to terrible. | 56 days | 
| International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months | 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. | 56 days | 
| Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge | 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. | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Flow Rate (Qmax) | It's used to determine the degree of urinary difficulty. | 56 days | 
| Postvoid Residual Volume (PVR) | The PVR urine test measures the amount of urine left in the bladder after urination. | 56 days | 
| Prostate Volume | It's related to progression of benign prostatic hyperplasia (BPH). | 56 days | 
| Prostate-specific Antigen (PSA) Level | 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. | 56 days |