Status:
COMPLETED
Research on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia
Lead Sponsor:
Golden Biotechnology Corporation
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
40+ years
Phase:
NA
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 dai...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02313233
Start Date
December 1 2013
End Date
May 1 2015
Last Update
June 21 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaohsiung Municipal TA- TUNG Hospital
Kaohsiung City, Taiwan, 80145