Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037154
Status:
COMPLETED
Last Update Posted:
2010-01-14
First Post:
2002-05-16
Brief Title:
Saw Palmetto Extract in Benign Prostatic Hyperplasia
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Saw Palmetto Extract In Benign Prostatic Hyperplasia
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 US 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None