N/A
N=41
Research on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia
Benign Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT02313233 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: International Prostate Symptom Score (IPSS) — 9.83; 13.6; -3.39; -5.94 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Umooze (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Golden Biotechnology Corporation
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Prostate Symptom Score (IPSS) |
9.83; 13.6; -3.39; -5.94 | — |
| PRIMARY Quality- Of- Life Index (QoL) |
2.72; 3.22; -0.61; -0.56 | — |
| PRIMARY International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months |
11.00; 14.33; -9.50; -4.33 | <0.05 sig |
| PRIMARY Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge |
2.73; 3.27; -0.82; -0.09 | <0.05 sig |
| SECONDARY Maximum Flow Rate (Qmax) |
14.4; 12.72; 2.88; 2.49 | — |
| SECONDARY Postvoid Residual Volume (PVR) |
35.3; 67.2; -8.39; 14.8 | <0.05 sig |
| SECONDARY Prostate Volume |
29.1; 38.2; -8.17; -1.33 | <0.05 sig |
| SECONDARY Prostate-specific Antigen (PSA) Level |
1.67; 2.22; 0.14; 0.26 | — |
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.
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 = 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.
Data sourced from ClinicalTrials.gov (NCT02313233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.