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Sponsors and Collaborators: |
Min-Sheng General Hospital Acrobio Healthcare Inc. |
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Information provided by: | Min-Sheng General Hospital |
ClinicalTrials.gov Identifier: | NCT00305071 |
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 |
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Pyuria Urinary Tract Infections |
Drug: compound cranberry extract tablet |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 60 |
Study Start Date: | April 2006 |
Ages Eligible for Study: | 20 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Taiwan | |
Min-Sheng General Hospital | |
Taoyuan City, Taiwan, 320 |
Principal Investigator: | Po-Chien Huang, MD | Division of Urology, department of Surgery, Min-Sheng General Hospital, Taoyuan, Taiwan |
Study ID Numbers: | ICMJE IRB NO:950113-1 |
Study First Received: | March 19, 2006 |
Last Updated: | March 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00305071 |
Health Authority: | Taiwan: Department of Health |
pyuria urinary tract infections Vaccinium macrocarpon |
Cystocele Urologic Diseases Urinary Bladder Diseases |
Urinary Tract Infections Cystitis Pyuria |
Infection |