D-004 in patients with Bening Prostatic Hyperplasia

Phase 3

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: RPCEC00000138
• Lead Sponsor: atural Products Center (CPN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 100

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

Exclusion Criteria

1. Prostate Cancer 2. Prior urological surgery 3. Urinary retention 4. Urinary tract infection 5. Criteria to be catheterized in next 3 months 6. PSA> 5 ng / mL 7. Acute myocardial infarction, stroke, transient ischemic attack or major surgery within 6 months previous 8. History of heart failure 9. History of hepatic failure 10. Blood Pressure > 180/110 mm Hg 11. Diagnosed neoplasias 12. Treatment with alpha 1 adrenergic antagonists, inhibitors of 5-alpha reductase, androgens,antiandrogens, cholinergics, anticholinergics,steroids and/or phytotherapy for BPH in 6 months prior study 13. Alcoholism 14. Other problems that limit its response to IPSS 15. Common history of drug allergy or any other condition that affects patient´s health and life during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (Mild 1-7, Moderate 8-18, Severe 19-35). Measuring time: at baseline, and at 2, 4 and 6 months.