RPCEC00000138
Not yet recruiting
Phase 3
Comparative study of medium-term effects of D-004 and Saw palmetto (320 mg / d) in patients with benign prostatic hyperplasia (BPH)
atural Products Center (CPN)0 sites100 target enrollmentJanuary 4, 2013
ConditionsBenign Prostatic Hyperplasia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- atural Products Center (CPN)
- Enrollment
- 100
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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