NCT00381108

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 6, 2010

Status Verified

January 1, 2010

Enrollment Period

4.8 years

First QC Date

September 26, 2006

Last Update Submit

January 4, 2010

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Pomegranate Tablet

EXPERIMENTAL
Drug: Pomegranate Tablet

Placebo Tablet

PLACEBO COMPARATOR
Drug: Placebo Tablet

Interventions

Placebo TabletDRUG

Two tablets, twice daily.

Placebo Tablet
Pomegranate TabletDRUG

Two tablets, twice daily.

Pomegranate Tablet

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Clinically diagnosed with mild to moderate BPH (AUA symptom score \<20)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Long Beach

Long Beach, California, 90822, United States

Location

University of California, Irvine-Department of Urology

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Leland Ronningen, MD

    UCIMC Department of Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 27, 2006

Study Start

September 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 6, 2010

Record last verified: 2010-01

Locations

US(2)