Treatment of Recurrent Urinary Tract Infection (RUTI) by Traditional Chinese Medicine

Recurrent Urinary Tract Infection Clinical Trial

Official title:

Study on Treatment of Recurrent Urinary Tract Infection by Traditional Chinese Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01745328
• Other study ID #: WJUTI
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2012
• Last updated: December 7, 2012
• Start date: January 2009
• Est. completion date: July 2013

Study information

• Verified date: December 2012
• Source: Beijing Institute of Disease Control and Prevention
• Contact: Shiwei Liu, Dr
• Phone: 86-10-84739029
• Email: liushiwei1977[@]yeah.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Traditional Chinese Medicine (TCM) could be used to treat Recurrent urinary tract infection (RUTI).

Description:

Antibiotics and TCM are used to treat RUTI to evaluate treatment efficiencies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• uncomplicated RUTI

Exclusion Criteria:

• complicated RUTI

• other disease with urinary tract

• infection by pathogens other than bacteria

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Recurrent Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• LVX-AMX
Subjects were treated with Levofloxacin, 200mg bid, Amoxicillin, 500mg tid for 1 week, followed by 3 week of placebo.
• TCM
Subject is treated with TCM for 4 weeks.
• LVX-AMX
treatment with placebo from 2 to 4 weeks.

Locations

Country	Name	City	State
China	Wangjing Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Institute of Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of recurrent urinary tract infection	Patients are checked at 4 weeks at the end of the treatment to confirm recovery of RUTI.	4 weeks after study drug start	No
Secondary	Urinary albumin	Urinary albumin is checked in patient urine.	4 weeks after drug start	No
Secondary	WBC conversion	Check the WBC count in patient urine.	4 weeks after drug start	No
Secondary	Urination frequency	Checked for urination frequency at 4 weeks after drug start.	4 weeks after drug start	No
Secondary	Recurrence	Patients are checked for recurrence rate at 6 months after drug start by telephone interview.	6 months after drug start	No
Secondary	urgency	Check urgency 4 weeks after drug start	4 weeks after drug start	No