Study of the Effects of Pomegranate Tablets on Enlarged Prostates

January 4, 2010 updated by: University of California, Irvine

A Randomized, Double Blinded, Controlled Clinical Trial of Pomegranate Tablets vs Placebo: Effects on Symptoms of Benign Prostatic Hyperplasia

To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic Hyperplasia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with newly diagnosed benign prostatic hyperplasia (BPH) will be recruited from the urology clinic at UCI medical center for this study as indicated in section 4. Once recruited, patients will be randomized into two groups - placebo and pomegranate tablets.

Prior to randomization, there will be a 6 week run-in period in which the basal parameters will be established. The basal parameters include a complete history and physical exam including an AUA symptom questionnaire and men's sexual health questionnaire, urine culture, urinalysis, PSA, serum chemistry (sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose), serum free testosterone, serum dihydrotestosterone, maximum urinary flow rate (Qmax), post void residual bladder volume, and prostate volume measurement via Trans-rectal ultrasound. Then patients will be randomized either to the study group or to the control group using a random number generator. All of the study subjects will be counseled to take one capsule daily in the morning and not to consume any other prostate supplements, or other forms of medical or herbal therapy for BPH.

Patients will be asked to come in every 2 months for the following tests and questionnaires to be administered:

  1. AUA Symptoms Score sheet
  2. Men's Sexual Health Questionnaire
  3. Urine culture
  4. Urinalysis
  5. PSA
  6. Serum chemistry (sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose)
  7. Serum free testosterone
  8. Serum 5-dihydrotestosterone
  9. Maximum urinary flow rate (Qmax)
  10. Post void residual check
  11. Prostate volume measurement via Trans-rectal ultrasound

Maximum blood volume that will be drawn for each blood draw is 10 ml (2 table spoon), and the maximum blood draws per patient is 3 per person if there is no crossover and 6 if there is a crossover. Prior to all blood draw, patients will be asked to refrain from sexual intercourse for at least 48 hrs.

Patients with severe BPH (AUA symptom score 20 and above) or those already on other forms of medical therapy such as prescription finasteride, terazosin, or tamsulosin, propecia (for hair loss) or have any history of prostate surgery are not eligible to participate in this study. Also, patients who are taking non prescription supplements such as Saw Palmetto, B-sitosterol, vitamin E, quercetin, will not be included in the study. One group (n = 10) will take the pomegranate tablet. Group 2 (n = 10) will take 1 placebo tablet in the morning daily. Both pomegranate tablets and placebo will be provided by the Pomegranate Health Company.

Prior to randomization, there will be a 6-week run-in time because voiding parameters are notoriously variable. During this run-in time, patients will be asked to return to clinic every two weeks to measure maximum urinary flow and post-void residual bladder volume.

After a six-month period, each subject will be crossed over individually from placebo to active treatment, and from active treatment to placebo. The total anticipated timeline for the study is 12 months.

If early termination from the study is requested a final evaluation will be given. The final evaluation of the study will entail a standard office visit with blood collection and final AUA symptoms score and Men's sexual health questionnaire, and a transrectal ultrasound of the prostate measuring the same parameters as in the previous office visits. Subsequently, recommendations will be made by a urologist regarding the standard treatment options for BPH.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90822
        • VA Long Beach
      • Orange, California, United States, 92868
        • University of California, Irvine-Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pomegranate Tablet
Drug: Pomegranate Tablet
Two tablets, twice daily.
Placebo Comparator: Placebo Tablet
Drug: Placebo Tablet
Two tablets, twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time points in which data is collected are initial visit, two weeks, four weeks, and 2, 4, 6, 8, 10, and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Pomegranate Health
Jarrow Pharmaceuticals

Investigators

  • Principal Investigator: Leland Ronningen, MD, UCIMC Department of Urology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

September 26, 2006

First Submitted That Met QC Criteria

September 26, 2006

First Posted (Estimate)

September 27, 2006

Study Record Updates

Last Update Posted (Estimate)

January 6, 2010

Last Update Submitted That Met QC Criteria

January 4, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-4373

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe