Clinical trial NCT02313233: Research on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia
Official title: Research on Benefit of Umooze as Add-on Therapy in Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Golden Biotechnology Corporation
Sponsor class: INDUSTRY
First posted: 2014-12-10
Enrollment: 41
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 56 days
measure: Quality- Of- Life Index (QoL)
timeFrame: 56 days
measure: International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months
timeFrame: 56 days
measure: Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge
timeFrame: 56 days
Secondary outcomes:
measure: Maximum Flow Rate (Qmax)
timeFrame: 56 days
measure: Postvoid Residual Volume (PVR)
timeFrame: 56 days
measure: Prostate Volume
timeFrame: 56 days
measure: Prostate-specific Antigen (PSA) Level
timeFrame: 56 days
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Municipal TA- TUNG Hospital
Study officials:
affiliation: Kaohsiung Municipal Ta-Tung Hospital
name: Ching- Chia Li, M.D
role: PRINCIPAL_INVESTIGATOR
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