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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00305071
Recruitment Status : Unknown
Verified March 2006 by Min-Sheng General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 21, 2006
Last Update Posted : March 21, 2006
Acrobio Healthcare Inc.
Information provided by:
Min-Sheng General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Pyuria Urinary Tract Infections Drug: compound cranberry extract tablet Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of Adjuvant Treatment With Compound Cranberry Extract Tablets (UmayC) in Acute Bacterial Cystitis.
Study Start Date : April 2006

Primary Outcome Measures :
  1. Time to symptoms relief

Secondary Outcome Measures :
  1. Pyuria eradication rate

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • female patient with non-complicated acute bacterial cystitis

Exclusion Criteria:

  • recent (less than one month) urinary tract infection
  • partially treated acute cystitis
  • anatomical or function disease of the lower urinary tract
  • patients received radical pelvic surgery
  • associated bladder stone disease
  • upper urinary tract anomaly or urolithiasis
  • systemic infection with body temperature higher than 38°C
  • known allergic reaction to cranberry or vitamin C
  • pregnant or prepare to be pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00305071

Contact: Po-Chien Huang, MD 886-3-3179599 ext 8223
Contact: Hung-Ju Yang, MD 886-3-3179599 ext 8225

Min-Sheng General Hospital Not yet recruiting
Taoyuan City, Taiwan, 320
Contact: Po-Chien Huang, MD    886-3-3179599 ext 8223   
Sponsors and Collaborators
Min-Sheng General Hospital
Acrobio Healthcare Inc.
Principal Investigator: Po-Chien Huang, MD Division of Urology, department of Surgery, Min-Sheng General Hospital, Taoyuan, Taiwan Identifier: NCT00305071     History of Changes
Other Study ID Numbers: ICMJE IRB NO:950113-1
First Posted: March 21, 2006    Key Record Dates
Last Update Posted: March 21, 2006
Last Verified: March 2006

Keywords provided by Min-Sheng General Hospital:
urinary tract infections
Vaccinium macrocarpon

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases
Urinary Bladder Diseases