Clinical Trial: Effect of Adjuvant Treatment With Compound Cranberry Extract Tablets in Acute Bacterial Cystitis.
Study Status: Available
Recruit Status: Unknown status
Study Type: Interventional
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.
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.
Detailed Summary:
Introduction
Acute bacterial cystitis is a common and bothersome disease with a rapid onset nature. Uncomplicated cystitis occurs in patients without anatomical or physiological anomaly in the lower urinary tract. Although the infection is not life threatening in immuno-competent patients, the associated lower urinary tract symptoms cause massive impact on the quality-of-life of the victims. The voiding symptoms, such as urinary frequency, urgency, dysuria and suprapubic pain, were associated with the inflammatory response to microbial invasion. In most clinical scenario, 3-day empirical oral antimicrobial treatment could eradicate the pathogen efficiently.1,2 However, the lower urinary tract symptoms were not eradicated effectively by antibiotics only. In daily clinical practice, several symptomatic relieving treatments were applied while acute infection presented, including pyridine and anticholinergic agents. However, several side effects were complained according to the medication.
In lower urinary tract infection, the virulence of the pathogen was the major factor associated with colonization and invasion in the urinary tract mucosa. The adherence of the pathogen to the urothelium is the crucial step in the urinary tract infection.3 Several studies revealed good anti-adherence effect of the cranberry juice.4-7 In several clinical studies, cranberry juice has been proven to be an protective effect in bacterial cystitis8 and the role of cranberry juice in preventing urinary tract infection was well established.9,10 Cranberry is a rich source of bioactive compounds, such as phenolic acid and several organic acids, which have been proven playing major anti-bacterial effect.11
In literature reviewing, the clinical application of cranberry juice or extract tablet was focusin
Sponsor: Min-Sheng General Hospital
Current Primary Outcome: Time to symptoms relief
Original Primary Outcome: Same as current
Current Secondary Outcome: Pyuria eradication rate
Original Secondary Outcome: Same as current
Information By: Min-Sheng General Hospital
Dates:
Date Received: March 19, 2006
Date Started: April 2006
Date Completion:
Last Updated: March 19, 2006
Last Verified: March 2006
