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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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


Condition Intervention
Recurrent Urinary Tract Infection
 Drug: LVX-AMX
Drug: TCM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Study on Treatment of Recurrent Urinary Tract Infection by Traditional Chinese Medicine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Institute of Disease Control and Prevention:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LVX-AMX
subject is treated with LAV-AMX, then followed by placebo.
 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: LVX-AMX
treatment with placebo from 2 to 4 weeks.
Other Name: placebo from 2 to 4 weeks.
Active Comparator: TCM treatment
subject is treated with TCM
 Drug: TCM
Subject is treated with TCM for 4 weeks.
Other Name: TCM formula consisted of 10 herbals

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • uncomplicated RUTI

Exclusion Criteria:

  • complicated RUTI
  • other disease with urinary tract
  • infection by pathogens other than bacteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745328

Contacts
Contact: Shiwei Liu, Dr 86-10-84739029 liushiwei1977@yeah.net

Locations
China, Beijing
Wangjing Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Shiwei Liu, Dr     86-10-84739029     liushiwei1977@yeah.net    
Principal Investigator: Shiwei Liu, Dr            
Sponsors and Collaborators
Beijing Institute of Disease Control and Prevention
Investigators
Principal Investigator: Zeliang Chen, Dr Insititute of Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Beijing Institute of Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01745328     History of Changes
Other Study ID Numbers: WJUTI
Study First Received: December 5, 2012
Last Updated: December 7, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Institute of Disease Control and Prevention:
recurrent urinary tract infection
antibiotics
traditional chinese medicine

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Amoxicillin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on May 16, 2013