D-004 in patients with Bening Prostatic Hyperplasia

INTERVENTION: Study group (D‐004 (code research)): 1 softgel capsules (320 mg) daily, by oral route for 6 months. Control group (Saw palmetto): 1 softgel capsules (320 mg) daily, by oral route for 6 months CONDITION: Benign Prostatic Hyperplasia PRIMARY OUTCOME: International Prostate Symptom Score (Mild 1‐7, Moderate 8‐18, Severe 19‐35). Measuring time: at baseline, and at 2, 4 and 6 months. SECONDARY OUTCOME: Prostate size (in cm, determined by transrectal ultrasound). Measuring time: at baseline, 6 months after treatment Retention volume (in mm, determined by transrectal ultrasound). Measuring time: at baseline, 6 months after treatment Symptoms relief (subjective assessment of symptoms: no changes, better, worse) Measuring time: 6 months after treatment. Physical exam (Weigth (kg), Blood presure (mm Hg), Cardiac frequency (Pulse por minute)). Measuring time: at baseline, and 2,4 and 6 months. Hematologic parameters (hemoglobin (g / dL), hematocrit (%), leukocyte count (cells x 10 9 / L), red blood cells (cells x 10 12 / L), platelets (cells x 10 9 / L)). Measuring time: at baseline and 6 months. Blood biochemical parameters (alanine amino transferase (ALT) (U / L), aspartate aminotransferase (AST) (U / L), glucose (mmol / L), creatinine (mmol / L), total cholesterol (mmol / L) , Triglycerides (mmol / L), LDL‐C (mmol / L), HDL‐C (mmol / L)). Measuring time: at baseline and 6 months. PSA test (PSA, ng/mL). Measuring time: at baseline and 6 months. Adverse Events (AE). Measuring time: 2, 4 y 6 months of treatment Description of the AE (name of the event) Intensity of AE(Mild, Moderate, Severe) Relationship (WHO scale‐ Very probable, Probable, Possible, Remote, Not related, Unknown). INCLUSION CRITERIA: 1. Patients with 50 years old or older 2. Informed consent 3. IPSS score between 7 and 19 4. Enlarged prostate checked by rectal examination