Study of the Effects of Pomegranate Tablets on Enlarged Prostates

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00381108
• Other study ID #: 2005-4373
• Status: Unknown status
• Phase: Phase 1
• First received: September 26, 2006
• Last updated: January 4, 2010
• Start date: September 2005
• Est. completion date: June 2010

Study information

• Verified date: January 2010
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Placebo Tablet
Two tablets, twice daily.
• Pomegranate Tablet
Two tablets, twice daily.

Locations

Country	Name	City	State
United States	VA Long Beach	Long Beach	California
United States	University of California, Irvine-Department of Urology	Orange	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Jarrow Pharmaceuticals, Pomegranate Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 points in which data is collected are initial visit, two weeks, four weeks, and 2, 4, 6, 8, 10, and 12 months.