Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms

Launched by HEALTH EVER BIO-TECH CO., LTD. · Oct 25, 2009

Keywords

ClinConnect Summary

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.

Gender

MALE

Eligibility criteria

• 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.