CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 369 enrolled
Drug / intervention
Saw Palmetto - first 24 weeks +5 moredrug
Likely dose
Saw Palmetto - first 24 weeks 320 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00603304
NCT00603304Phase 3Completed
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Complementary and Alternative Medicine for Urological Symptoms (CAMUS)

University of Alabama at Birmingham·interventional·Posted Jan 29, 2008·Updated Oct 12, 2012

In Brief

A Phase 3 clinical trial evaluating Saw Palmetto - first 24 weeks, Placebo - first 24 weeks, and 4 other interventions for Urological. Completed, enrolled 369 participants across 11 sites in 2 countries.

Detailed Summary

The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the CAMUS trial will be given one out of two possible treatments at random. One out of every two men would get an inactive placebo treatment. One out of every two men would get Saw palmetto pills. This kind of scientific study is the best way to find out if the plant extracts really work to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study, men will not know which of the two treatments they are assigned to. They will be followed very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial will be studied over 72 weeks. Tests and all medications needed as part of the study will be provided at no charge to the participant. Participants will be responsible for all other costs not associated with the study tests and medications. All information on study participants will be held in the strictest confidence and no one would have access to patient information other than the required authorized health care and research personnel.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrological
CountriesCanada, United States
CollaboratorsOffice of Dietary Supplements (ODS), National Center for Complementary and Integrative Health (NCCIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Cornell University, New York University, Kaiser Permanente, Northwestern University, Queen's University, University of Colorado, Denver, University of Iowa, University of Maryland, University of Texas, Washington University School of Medicine, Yale University

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 29, 2008
Enrollment StartFeb 1, 2008
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.4 years ago

Interventions

Saw Palmetto - first 24 weeksdrug

Participants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.

Placebo - first 24 weeksdrug

Participants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.

Saw Palmetto - weeks 24 - 48drug

Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.

Placebo - weeks 24 - 48drug

Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a placebo for 24 weeks.

Saw Palmetto - weeks 48 - 72drug

Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.

Placebo - weeks 48 - 72drug

Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.