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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Min-Sheng General Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Acrobio Healthcare Inc.
Information provided by:
Min-Sheng General Hospital
ClinicalTrials.gov Identifier:
NCT00305071
First received: March 19, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

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 Intervention Phase
Pyuria
Urinary Tract Infections
Drug: compound cranberry extract tablet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Min-Sheng General Hospital:

Primary Outcome Measures:
  • Time to symptoms relief

Secondary Outcome Measures:
  • Pyuria eradication rate

Estimated Enrollment: 60
Study Start Date: April 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305071

Contacts
Contact: Po-Chien Huang, MD 886-3-3179599 ext 8223 m001435@e-ms.com.tw
Contact: Hung-Ju Yang, MD 886-3-3179599 ext 8225 m001436@e-ms.com.tw

Locations
Taiwan
Min-Sheng General Hospital Not yet recruiting
Taoyuan City, Taiwan, 320
Contact: Po-Chien Huang, MD    886-3-3179599 ext 8223    m001435@e-ms.com.tw   
Sponsors and Collaborators
Min-Sheng General Hospital
Acrobio Healthcare Inc.
Investigators
Principal Investigator: Po-Chien Huang, MD Division of Urology, department of Surgery, Min-Sheng General Hospital, Taoyuan, Taiwan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00305071     History of Changes
Other Study ID Numbers: ICMJE IRB NO:950113-1
Study First Received: March 19, 2006
Last Updated: March 19, 2006
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Cystitis
Pyuria
Urinary Tract Infections
Urinary Bladder Diseases
Urologic Diseases
Infection

ClinicalTrials.gov processed this record on August 21, 2014