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
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.
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