drugset / Trial / NCT00037154
Saw Palmetto Extract in Benign Prostatic Hyperplasia
Phase 3
Completed
224 enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Complementary and Integrative Health (NCCIH) · collab
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 1999-08
- Primary completion
- —
- Completion
- 2002-12
Outcome
Missed primary endpoint
paper There was no significant difference between the saw palmetto and placebo groups in the change in AUASI scores PMID 16467543 ↗
paper AUASI scores (mean difference, 0.04 point; 95 percent confidence interval, -0.93 to 1.01) PMID 16467543 ↗
paper maximal urinary flow rate (mean difference, 0.43 ml per minute; 95 percent confidence interval, -0.52 to 1.38) PMID 16467543 ↗
Publications
- Results Bent S, Kane C, Shinohara K, Neuhaus J, Hudes ES, Goldberg H, Avins AL. Saw palmetto for benign prostatic hyperplasia. N Engl J Med. 2006 Feb 9;354(6):557-66. doi: 10.1056/NEJMoa053085.
- Avins AL, Bent S, Padula A, Staccone S, Badua E, Goldberg H. Initial experience with a group presentation of study results to research participants. Trials. 2008 Mar 21;9:16. doi: 10.1186/1745-6215-9-16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Saw Palmetto | Unknown | 160 mg | — |