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Study of the Effects of Pomegranate Tablets on Enlarged Prostates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of California, Irvine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Pomegranate Health
Jarrow Pharmaceuticals
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00381108
First received: September 26, 2006
Last updated: January 4, 2010
Last verified: January 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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. ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00381108

Locations
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
Investigators
Principal Investigator: Leland Ronningen, MD UCIMC Department of Urology
  More Information

No publications provided

Responsible Party: Leland Ronningnen, MD, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00381108     History of Changes
Other Study ID Numbers: 2005-4373
Study First Received: September 26, 2006
Last Updated: January 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
BPH

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014