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Home > "S" Clinical Trials Conditions > Saw Palmetto Extract in Benign Prostatic Hyperplasia  Saw Palmetto Extract in Benign Prostatic Hyperplasia
Saw Palmetto Extract in Benign Prostatic Hyperplasia
For Condition: Benign Prostatic Hyperplasia
Status: No longer recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , National Center for Complementary and Alternative Medicine (NCCAM)
Synopsis: The purpose of this study is to test whether an extract of the saw palmetto plant is effective for relieving symptoms of Benign Prostatic Hyperplasia (BPH).
Details: This proposal describes a double-blind, placebo-controlled randomized clinical trial of the effect of saw palmetto extract on symptoms, objective parameters of disease severity, and quality of life in men with moderate-to-severe benign prostatic hyperplasia. BPH, one of the most common morbid medical conditions in middle-aged and elderly men, is generally treated with alpha-adrenergic blocking agents, finasteride, surgical interventions, or no specific therapy ("watchful waiting"). In the past several years, however, many patients have begun to self-medicate with an extract of the saw palmetto plant (Serenoa repens), a medicinal herb grown in the southeastern United States. Saw palmetto has become the fifth leading medicinal herb consumed in the U.S. and is considered first-line therapy for BPH in several Western European countries. Several small studies suggest that saw palmetto may have clinical benefit, but the methodologic quality of most prior studies has been poor. Very few side effects of the herb have been observed, but few studies have been conducted for more than three months. We propose to conduct a high-quality clinical trial of saw palmetto, with careful attention to the methodologic deficiencies of prior studies. After a single-blind placebo run-in period, 224 patients with mode moderate-to-severe BPH (American Urological Association Symptom Index score greater than or equal to 8) and objective measurement of urinary obstruction, will be randomized to receive either 160mg BID of the herbal extract or an identical placebo. Patients will discontinue any other medical therapy for BPH prior to enrollment and all participants will undergo a trans-rectal ultrasound examination at baseline and closeout. Participants in the trial will be seen at 3-month intervals for a total one-year follow-up. Outcome measurements include changes in the AUASI score (the primary outcome measurement), the peak urinary flow rate, the post-void residual urine volume, the BPH Impact Index, the Olmstead County Study Questionnaire of BPH-specific symptoms and quality of life, and the Short-Form 36 (a generic health status instrument). Numerous laboratory parameters will measured at intervals throughout the trial and symptomatic side effects will be assessed.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 50 Years/
Genders: Male
Protocol Entry Criteria: Eligibility Criteria: - Participants must be men, aged 50 years or older with moderate-to-severe BPH. - Participants must not have a history of prostate cancer, prior surgery on the prostate, kidney failure, or taking furosemide (Lasix), warfarin (Coumadin), or hormone medications. Individuals taking medicine for their BPH must stop them for one month (prazosin, terazosin (Hytrin), doxazosin (Cardura), tamsulosin (Flomax)) or six months (saw palmetto, finasteride (Proscar or Rogaine)) prior to entering the study.
Total Enrollment: 224
Location and Contact Information:
Overall Study Official:
StephenBent, Study Director, University of California, San Francisco; San Francisco Veterans Affairs Medical Center
Northern California Kaiser Permanente
Oakland, California, 94611
United States
Veterans Affairs Medical Center
San Francisco, California, 94121
United States
Additional Information:
Study ID Numbers: 5 R01 DK056199-03;
Study Start Date: August 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037154
Other Benign Prostatic Hyperplasia Studies:
1. MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia
2. Safety/tolerability study of Alcohol Injection for Treatment of BPH (enlarged prostate)
3. Dose Escalation Study with QLT0074 for Benign Prostatic Hyperplasia
4. Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels
5. Saw Palmetto Extract in Benign Prostatic Hyperplasia
Related Studies:
Other Benign Prostatic Hyperplasia Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Saw Palmetto Extract in Benign Prostatic Hyperplasia
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