Effect of Adjuvant Treatment With Compound Cranberry Extract Tablets in Acute Bacterial Cystitis.
Recruitment status was Not yet recruiting
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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. |
- Time to symptoms relief
- 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 |
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| 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 | Not yet recruiting |
| Taoyuan City, Taiwan, 320 | |
| Contact: Po-Chien Huang, MD 886-3-3179599 ext 8223 m001435@e-ms.com.tw | |
| 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 June 18, 2013