Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Conditions
Keywords
Benign Prostatic Hyperplasia, Multi-carotenoids, MCS-2, Lower Urinary Tract Symptoms, International prostate symptom scores
Brief summary
The hypothesis of the study is to examine whether MCS-2 is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
Detailed description
Eligible male subjects will be randomized to receive either MCS-2 or placebo for 12 weeks. Subjects are those not currently on any medicines for BPH or LUTS. During and at the end of the 12-week treatment period, randomized subjects will be evaluated for efficacy and safety parameters. All subjects will be advised to maintain a normal diet, similar to what was consumed before joining the study.
Interventions
DRUGMCS-2
30 mg/day (two 15 mg capsules) Qd for 12 weeks
DRUGPlacebo
2 soft-gel placebo capsules Qd for 12 weeks
Sponsors
Health Ever Bio-Tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≧ 40 years old. * Not being treated for BPH or LUTS. * PSA ≦ 4 ng/ml and no pathologically-proven prostate cancer. * I-PSS ≥ 10 * No known malignancy * AST/ALT ≦ 3X UNL. * Creatinine ≦ 3X UNL. * Subjects who sign the informed consent form.
Exclusion criteria
* Subjects' LUTS are not BPH-related * Have been treated with pelvis irradiation or pelvic surgery. * Plan to undergo any invasive procedures within the study period. * Active infection or inflammation. * Considered ineligible by the investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in total International Prostate Symptom Scores (I-PSS) | 12 weeks | Changes in total International Prostate Symptom Scores (I-PSS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in I-PSS subscores | 12 weeks | Changes in I-PSS subscores |
| Changes in I-PSS quality of life index | 12 weels | Changes in I-PSS quality of life index |
| Changes in urinary peak flow rate | 12 weeks | Changes in urinary peak flow rate |
| Incidence of treatment-emergent adverse events | 12 weeks | Incidence of treatment-emergent adverse events |
| Incidence of withdrawals due to treatment-emergent adverse events | 12 weeks | Incidence of withdrawals due to treatment-emergent adverse events |
Countries
Taiwan
Outcome results
None listed