Effect of Adjuvant Treatment With Compound Cranberry Extract Tablets in Acute Bacterial Cystitis.
Recruitment status was Not yet recruiting
|First Received Date ICMJE||March 19, 2006|
|Last Updated Date||March 19, 2006|
|Start Date ICMJE||April 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Time to symptoms relief|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||Pyuria eradication rate|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effect of Adjuvant Treatment With Compound Cranberry Extract Tablets in Acute Bacterial Cystitis.|
|Official Title ICMJE||A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of Adjuvant Treatment With Compound Cranberry Extract Tablets (UmayC) in Acute Bacterial Cystitis.|
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.
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 focusing on the preventive role on chronic or repeated urinary tract infection. The effect to reduce bacteriuria and pyuria has been mentioned.12 However, the effect on lower urinary tract symptom relieving effect of the food supplement cranberry was not established. In this study, we try to evaluate the clinical efficacy of a commercial compound cranberry extract in treating acute uncomplicated cystitis as an adjunctive role. The compound tablet contained 900mg per tablet, including 600% concentrated cranberry extract 150mg, vitamin C 70mg, Rhizoma extract (Acrobio TS®) 150mg, Flos extract (Acrobio GL®) 60mg, lactose and mannitol 490mg. The compound has been on the market in Taiwan as a food supplement and was well tolerable. We conducted a double-blind, randomized, placebo-controlled trial to evaluate the adjuvant effect of compound cranberry extract on the symptomatic relieving effect.
Material and Methods
We prepare to conduct a paralleled-group, double-blind, placebo-controlled, randomized clinical 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. The treatment arm will receive standard 3-day oral antibiotics plus 7-day compound cranberry extract tablets (UmayC) and the control arm will receive standard 3-day oral antibiotics plus 7-day identical placebo.
After participant enrollment with inform consent, detail medical history will be collected, including basic physiological data (body weight and height), major medical disease (diabetes, cerebral vascular disease, or neurological disorder), major operation history (neurological and pelvic surgery), recent medication records (including recent antibiotics treatment), child-baring history, sexual activity, fluid drinking history, and socio-economical and education status.
A voiding symptoms questionnaire, including FUP score and 10-point Likert scales symptomatic questions, will be done by in-face interview by study assistants. Random urine bacterial culture will be collected before medical treatment. The participants will be requested to receive 2 telephone interviews on day 2 and 3 by the study assistants and to return for urinalysis and 2nd in-face questionnaire on day 4 after complete antibiotics treatment. The clinical follow up will be arranged on day 8 by the physicians and urinalysis will be done again.
Adverse event reporting and patient safety All participants will receive close follow up protocol for adverse event reporting. Any discomfort associated with the medical treatment will be recorded on daily interview record and be reported. Interruption of the trial and intervention decoding will be performed immediately once an intolerable side effect happened.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Drug: compound cranberry extract tablet|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||20 Years to 65 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Taiwan|
|NCT Number ICMJE||NCT00305071|
|Other Study ID Numbers ICMJE||ICMJE IRB NO：950113-1|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Min-Sheng General Hospital|
|Collaborators ICMJE||Acrobio Healthcare Inc.|
|Information Provided By||Min-Sheng General Hospital|
|Verification Date||March 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP