Complementary and Alternative Medicine for Urological Symptoms
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on May 07, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Hyperplasia
Intervention: Serenoa repens (Drug); Pygeum africanum (Drug); Tamsulosin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Overall contact:
Regina Ryan, Phone: 205-934-5165, Email: regina.gay@ccc.uab.edu
Summary
The primary objective of this trial is to determine if two phytotherapies (Serenoa repens or Pygeum africanum) delay or prevent the progression of Benign Prostatic Hyperplasia (BPH).
Clinical Details
Official title:
Complementary and Alternative Medicine for Urological Symptoms
Study design: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Time to clinical progression of BPH.
Detailed description:
Participants will be randomly assigned to one of the four treatments: extract of Serenoa repens, extract of Pygeum africanum, tamsulosin, or placebo. Participants will have clinic visits every four months for 4 years. The following assessments will be performed at study visits: a physical examination, a digital rectal examination, medical follow-up (new diagnoses, treatments, hospitalizations), urinalysis, vital signs, PSA, uroflow measurements, questionnaires related to prostate health, assessment of adverse events and medications. Blood chemistries and transrectal ultrasound (TRUS) will be performed on a subset of participants.
Eligibility
Minimum age: 45 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml
- American Urological Association symptom score between 8 and 24 at both screening visits
Locations and Contacts
Regina Ryan, Phone: 205-934-5165, Email: regina.gay@ccc.uab.edu
Kaiser Permanente Division of Research, Oakland, California 94612, United States; Recruiting
Study Coordinator, Phone: 613-533-2894
University of Colorado Health Sciences Center, Aurora, Colorado 80045, United States; Not yet recruiting
Study Coordinator, Phone: 720-848-1388
Northwestern University Medical School, Chicago, Illinois 60611, United States; Not yet recruiting
Study Coordinator, Phone: 312-908-7026 or 312-908-5396
University of Iowa, Iowa City, Iowa 52242, United States; Not yet recruiting
Study Coordinator, Phone: 319-384-5769 or 319-384-5064
University of Maryland School of Medicine, Baltimore, Maryland 21201, United States; Not yet recruiting
Study Coordinator, Phone: 410-328-7742
Washington University School of Medicine, St. Louis, Missouri 63110, United States; Not yet recruiting
Study Coordinator, Phone: 314-996-8282 or 314-996-8285
Study Coordinator
New York University, New York, New York 10016, United States; Not yet recruiting
Study Coordinator, Phone: 646-825-6328
Columbia University, New York, New York 10032, United States; Not yet recruiting
Study Coordinator, Phone: 212-305-0146 or 212-746-5351
Queen's University, Kingston, Ontario K7L 2V7, Canada; Not yet recruiting
Study Coordinator, Phone: 613-533-2894 or 613-549-6666, Ext: 3554
University of Texas - Southwestern Medical Center, Dallas, Texas 75390, United States; Not yet recruiting
Study Coordinator, Phone: 214-645-8787
Additional Information
Starting date:
March 2005
Ending date: March 2012
Last updated: May 1, 2007
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