Trial record 19 of 94 for:    Open Studies | "Urinary Tract Infections"

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 01, 2014