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

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ClinicalTrials.gov Identifier: NCT01745328
Recruitment Status : Unknown
Verified December 2012 by Beijing Institute of Disease Control and Prevention.
Recruitment status was:  Recruiting
First Posted : December 10, 2012
Last Update Posted : December 10, 2012
Sponsor:
Information provided by (Responsible Party):
Beijing Institute of Disease Control and Prevention

Study Description
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Brief Summary:
Traditional Chinese Medicine (TCM) could be used to treat Recurrent urinary tract infection (RUTI).

Condition or disease Intervention/treatment Phase
Recurrent Urinary Tract Infection Drug: LVX-AMX Drug: TCM Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study on Treatment of Recurrent Urinary Tract Infection by Traditional Chinese Medicine
Study Start Date : January 2009
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : July 2013

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Recovery of recurrent urinary tract infection [ Time Frame: 4 weeks after study drug start ]
    Patients are checked at 4 weeks at the end of the treatment to confirm recovery of RUTI.


Secondary Outcome Measures :
  1. Urinary albumin [ Time Frame: 4 weeks after drug start ]
    Urinary albumin is checked in patient urine.

  2. WBC conversion [ Time Frame: 4 weeks after drug start ]
    Check the WBC count in patient urine.

  3. Urination frequency [ Time Frame: 4 weeks after drug start ]
    Checked for urination frequency at 4 weeks after drug start.

  4. Recurrence [ Time Frame: 6 months after drug start ]
    Patients are checked for recurrence rate at 6 months after drug start by telephone interview.

  5. urgency [ Time Frame: 4 weeks after drug start ]
    Check urgency 4 weeks after drug start


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Beijing Institute of Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01745328     History of Changes
Other Study ID Numbers: WJUTI
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Amoxicillin
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
 Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors