Study of the Effects of Pomegranate Tablets on Enlarged Prostates
Study of the Effects of Pomegranate Tablets on Enlarged Prostates
To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic
 Hyperplasia.
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.
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.