Benign Prostatic Hyperplasia
Conditions
Keywords
Benign Prostatic Hyperplasia, MCS, Lower Urinary Tract Symptoms, International prostate symptom score, Voiding, Alpha-blockers
Brief summary
Phase III, Randomized, double-blind, parallel placebo-controlled study. Two arms: MCS (30mg/day) vs. placebo. Subproject MCS-2: alpha-blocker naïve subjects Subproject MCS-3: subjects responding poorly to alpha-blocker
Detailed description
For MCS-2 This is a double-blind, randomized, placebo-controlled, parallel study where eligible male subjects (age 40, N=188), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day or placebo for 12 weeks. Group A: MCS 30 mg/day for 12 weeks Group B: placebo for 12 weeks Subjects are limited to those who are currently not being treated medically for BPH or LUTS with alpha-blockers, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 85 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 188 subjects in total will be recruited onto the study. For MCS-3 This is a double-blind, randomized, placebo-controlled, add-on, parallel study where eligible male subjects (age 40, N=242), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day plus alpha-blocker or placebo plus alpha-blocker for 12 weeks. Group A: alpha-blocker plus MCS 30 mg/day Group B: alpha-blocker plus placebo Subjects are limited to those who are currently not being treated medically for BPH or LUTS with anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 220 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 242 subjects in total will be recruited onto the study. All participating subjects will be advised to maintain a normal diet as they do before joining the study. However, participating subjects are advised to refrain from extra source of carotenoids supplementation and MCS extracts made into a capsule, soft gel, or crude granule extracts.
Interventions
DRUGMCS
soft-gel capsule, 15 mg/cap., Qd, 12 weeks
DRUGPlacebo
soft-gel capsule, Qd, 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
for subproject MCS-2 * Age ≧ 40 years old. * Not being treated for BPH or LUTS with Alpha-blocker, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal agents. * PSA≦4 ng/ml within 4 weeks of V1 and no pathologically-proven prostate cancer. * No known malignancy, except cancers without signs of recurrence for \> 5 years and no need for further anti-cancer treatment. * AST/ALT≦3X UNL. * creatinine≦3X UNL. * Subjects who sign the informed consent form.
Exclusion criteria
* Subjects' LUTS are not BPH-related but are associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures. * Have been treated with pelvis irradiation or pelvic surgery. * Plan to undergo any invasive procedures within the study period, such as, prostate surgery, prostate biopsy, cystourethroscopy, pelvic surgery, laparotomy, or any procedures needing urethral catheterization. * Participating in another investigational agent study in the past 12 weeks or are going to do so during the study period. * Active infection or inflammation. * Considered ineligible by the investigators. Inclusion criteria for subproject MCS-3 * Age≧40 years old. * The alpha-blocker dosage used should be as high as subjects can tolerate. * No known malignancy, except cancers without signs of recurrence for \> 5 years and no need for further anti-cancer treatment. * PSA≦10.0 ng/ml without pathologically-proven prostate cancer or other cancers. Prostate biopsy is mandatory \> 12 weeks before screening, if PSA is≧4 ng/ml to rule out prostate cancer. * AST/ALT≦3X UNL. * Creatinine≦3X UNL. * Subjects who sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation. | 12 weeks |
| MCS-3: To compare the percentage of subjects who achieve an I-PSS reduction by 4 or more points from baseline at 12 weeks between the MCS and the placebo arms. | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the general safety and tolerability. | 12 weeks |
Countries
Taiwan
Outcome results
None listed