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.

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.

  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:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014