Benign Prostatic HyperplasiaPhase 1NCT00381108
Study of the Effects of Pomegranate Tablets on Enlarged Prostates
A Phase 1 study testing Pomegranate Tablet in people with Benign Prostatic Hyperplasia, run by University of California, Irvine at 2 sites in United States.
Trial summary
To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic Hyperplasia. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Pomegranate Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2005to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Clinically diagnosed with mild to moderate BPH (AUA symptom score <20)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Long Beach
Long Beach, California, 90822
University of California, Irvine-Department of Urology
Orange, California, 92868
About this study
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.
Read the 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:
- AUA Symptoms Score sheet
- Men's Sexual Health Questionnaire
- Urine culture
- Urinalysis
- PSA
- Serum chemistry (sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose)
- Serum free testosterone
- Serum 5-dihydrotestosterone
- Maximum urinary flow rate (Qmax)
- Post void residual check
- 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Placebo Tablet, Pomegranate Tablet
- Keywords
- BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo TabletDrug
Two tablets, twice daily.
Pomegranate TabletDrug
Two tablets, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate Tablet | Experimental | Not described Receives: Drug: Pomegranate Tablet |
| Placebo Tablet | Placebo comparator | Not described Receives: Drug: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time points in which data is collected are initial visit, two weeks, four weeks, and 2, 4, 6, 8, 10, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startSep 2005
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Pomegranate Health, Jarrow Pharmaceuticals
- Investigators
- Leland Ronningen, MD, Principal investigator, UCIMC Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381108
- Sponsor's protocol ID
- 2005-4373
- Status last verified
- Jan 2010
- First submitted
- 26 Sep 2006
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Controlled Clinical Trial of Pomegranate Tablets vs Placebo: Effects on Symptoms of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00381108
- Acronym / sponsor ID
- 2005-4373
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Pomegranate Health, Jarrow Pharmaceuticals
- Study start
- Sep 2005
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 27 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic Hyperplasia.
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:
- AUA Symptoms Score sheet
- Men's Sexual Health Questionnaire
- Urine culture
- Urinalysis
- PSA
- Serum chemistry (sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose)
- Serum free testosterone
- Serum 5-dihydrotestosterone
- Maximum urinary flow rate (Qmax)
- Post void residual check
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomegranate Tablet | Experimental | Drug: Pomegranate Tablet |
| Placebo Tablet | Placebo comparator | Drug: Placebo Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Clinically diagnosed with mild to moderate BPH (AUA symptom score <20)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo TabletTwo tablets, twice daily. | Drug | Placebo Tablet |
| Pomegranate TabletTwo tablets, twice daily. | Drug | Pomegranate Tablet |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leland Ronningen, MD principal investigator
UCIMC Department of Urology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pomegranate Tablet in people with Benign Prostatic Hyperplasia, run by University of California, Irvine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2010.