Effect of Adjuvant Treatment With Compound Cranberry Extract Tablets in Acute Bacterial Cystitis.

NCT00305071 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2006-03-21

No results posted yet for this study

Summary

In conventional treatment for non-complicated bacterial cystitis, 3-day oral antibiotics could achieve good cure rate. However, severe lower urinary tract symptoms were most bothersome and only could be partially relieved by NSAID, detrusor muscle relaxants, minor tranquilizer or pyridium. Some medication associated side effects were complained while receiving adjuvant medication treatment, including gastro-intestinal discomfort, dry mouth, blurred vision, lethargy, or allergic reactions. The irritative bladder symptoms from bladder inflammation had great impact on the quality of life and well tolerable adjuvant therapy would have clinical benefit to reduce the discomfort from the bladder.

In the past years, cranberry juice or its extract has been proven to have protective effect on urothelium to prevent further bacterial ascending infection. The commercial cranberry extract tablets have good tolerability and showed good effect on symptoms reliving and infection protection on several clinical observation. In acute bladder infection, we could expect the bioactive components in cranberry could reduce the virulence of pathogens and assist to eradicate pathogens and to stable the urothelium. In literature review, only little works focusing on the symptoms relief in acute cystitis patients. To clarify the clinical benefit on lower urinary symptoms relieving, we attempt to conduct a randomized double-blind placebo-controlled trial to evaluate the effect of a compound cranberry extract tablet as an adjunctive modality in treating acute uncomplicated bacterial cystitis in otherwise healthy female patients.

Conditions

Interventions

DRUG

compound cranberry extract tablet

Sponsors & Collaborators

  • Acrobio Healthcare Inc.

    collaborator INDUSTRY
  • Min-Sheng General Hospital

    lead OTHER

Principal Investigators

  • Po-Chien Huang, MD · Division of Urology, department of Surgery, Min-Sheng General Hospital, Taoyuan, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00305071 on ClinicalTrials.gov