Complementary and Alternative Medicine for Urological Symptoms(CAMUS)

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.

Conditions

• Urological

Interventions

DRUG

Saw Palmetto - first 24 weeks

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

DRUG

Placebo - first 24 weeks

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

DRUG

Saw Palmetto - weeks 24 - 48

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

DRUG

Placebo - weeks 24 - 48

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

DRUG

Saw Palmetto - weeks 48 - 72

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

DRUG

Placebo - weeks 48 - 72

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

Sponsors & Collaborators

• Office of Dietary Supplements (ODS)

  collaborator NIH

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Cornell University

  collaborator OTHER

• New York University

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• Queen's University

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• University of Texas

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Yale University

  collaborator OTHER

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Michael Barry, MD · Massachusetts General Hospital

• Alan Cantor, PhD · The University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-02-29

Primary Completion

2010-12-31

Completion

2010-12-31

Countries

• United States
• Canada

Study Locations