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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Beijing Institute of Disease Control and Prevention
Sponsor:
Information provided by (Responsible Party):
Beijing Institute of Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01745328
First received: December 5, 2012
Last updated: December 7, 2012
Last verified: December 2012

December 5, 2012
December 7, 2012
January 2009
March 2013   (final data collection date for primary outcome measure)
Recovery of recurrent urinary tract infection [ Time Frame: 4 weeks after study drug start ] [ Designated as safety issue: No ]
Patients are checked at 4 weeks at the end of the treatment to confirm recovery of RUTI.
Same as current
Complete list of historical versions of study NCT01745328 on ClinicalTrials.gov Archive Site
  • Urinary albumin [ Time Frame: 4 weeks after drug start ] [ Designated as safety issue: No ]
    Urinary albumin is checked in patient urine.
  • WBC conversion [ Time Frame: 4 weeks after drug start ] [ Designated as safety issue: No ]
    Check the WBC count in patient urine.
  • Urination frequency [ Time Frame: 4 weeks after drug start ] [ Designated as safety issue: No ]
    Checked for urination frequency at 4 weeks after drug start.
  • Recurrence [ Time Frame: 6 months after drug start ] [ Designated as safety issue: No ]
    Patients are checked for recurrence rate at 6 months after drug start by telephone interview.
  • urgency [ Time Frame: 4 weeks after drug start ] [ Designated as safety issue: No ]
    Check urgency 4 weeks after drug start
Same as current
Not Provided
Not Provided
 
Treatment of Recurrent Urinary Tract Infection (RUTI) by Traditional Chinese Medicine
Study on Treatment of Recurrent Urinary Tract Infection by Traditional Chinese Medicine

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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Recurrent Urinary Tract Infection
  • Drug: LVX-AMX
    Subjects were treated with Levofloxacin, 200mg bid, Amoxicillin, 500mg tid for 1 week, followed by 3 week of placebo.
    Other Name: Levofloxacin, 200mg bid, Amoxicillin, 500mg tid
  • Drug: TCM
    Subject is treated with TCM for 4 weeks.
    Other Name: TCM formula consisted of 10 herbals
  • Drug: LVX-AMX
    treatment with placebo from 2 to 4 weeks.
    Other Name: placebo from 2 to 4 weeks.
  • Active Comparator: LVX-AMX
    subject is treated with LAV-AMX, then followed by placebo.
    Interventions:
    • Drug: LVX-AMX
    • Drug: LVX-AMX
  • Active Comparator: TCM treatment
    subject is treated with TCM
    Intervention: Drug: TCM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
July 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • uncomplicated RUTI

Exclusion Criteria:

  • complicated RUTI
  • other disease with urinary tract
  • infection by pathogens other than bacteria
Both
18 Years to 75 Years
No
Contact: Shiwei Liu, Dr 86-10-84739029 liushiwei1977@yeah.net
China
 
NCT01745328
WJUTI
No
Beijing Institute of Disease Control and Prevention
Beijing Institute of Disease Control and Prevention
Not Provided
Principal Investigator: Zeliang Chen, Dr Insititute of Disease Control and Prevention
Beijing Institute of Disease Control and Prevention
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP