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Study of the Effects of Pomegranate Tablets on Enlarged Prostates

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by University of California, Irvine.
Recruitment status was:  Active, not recruiting
Pomegranate Health
Jarrow Pharmaceuticals
Information provided by:
University of California, Irvine Identifier:
First received: September 26, 2006
Last updated: January 4, 2010
Last verified: January 2010
To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic Hyperplasia.

Condition Intervention Phase
Benign Prostatic Hyperplasia Drug: Placebo Tablet Drug: Pomegranate Tablet Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blinded, Controlled Clinical Trial of Pomegranate Tablets vs Placebo: Effects on Symptoms of Benign Prostatic Hyperplasia

Resource links provided by NLM:

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Patients w/ BPH symptoms will be followed w/ AUA symptom questionnaires & exams; in addition, urinary flow rate & post void residual checks will be done to determine whether patients on pomegranate tablets have a reduction in symptoms. [ Time Frame: Time points in which data is collected are initial visit, two weeks, four weeks, and 2, 4, 6, 8, 10, and 12 months. ]

Estimated Enrollment: 20
Study Start Date: September 2005
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pomegranate Tablet Drug: Pomegranate Tablet
Two tablets, twice daily.
Placebo Comparator: Placebo Tablet Drug: Placebo Tablet
Two tablets, twice daily.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older
  • Clinically diagnosed with mild to moderate BPH (AUA symptom score <20)

Exclusion Criteria:

  • Patient with severe BPH (AUA symptom score >21)
  • Currently using any other forms of medical therapy, prescription finasteride, terazosin, tamsulosin or propecia (for hair loss).
  • Prior Transurethral resection of the prostate (TURP).
  • Using non-prescription supplements such as Saw Palmetto, B-sitosterol, vitamin E, and quercetin.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00381108

United States, California
VA Long Beach
Long Beach, California, United States, 90822
University of California, Irvine-Department of Urology
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Pomegranate Health
Jarrow Pharmaceuticals
Principal Investigator: Leland Ronningen, MD UCIMC Department of Urology
  More Information

Responsible Party: Leland Ronningnen, MD, University of California, Irvine Identifier: NCT00381108     History of Changes
Other Study ID Numbers: 2005-4373
Study First Received: September 26, 2006
Last Updated: January 4, 2010

Keywords provided by University of California, Irvine:

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male processed this record on September 21, 2017