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

December 7, 2012 updated by: Beijing Institute of Disease Control and Prevention

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Wangjing Hospital
        • Contact:
        • Principal Investigator:
          • Shiwei Liu, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • uncomplicated RUTI

Exclusion Criteria:

  • complicated RUTI
  • other disease with urinary tract
  • infection by pathogens other than bacteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Levofloxacin, 200mg bid, Amoxicillin, 500mg tid
Drug: LVX-AMX
treatment with placebo from 2 to 4 weeks.
Other Names:
  • 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 Names:
  • TCM formula consisted of 10 herbals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks after study drug start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary albumin
Time Frame: 4 weeks after drug start
Urinary albumin is checked in patient urine.
4 weeks after drug start
WBC conversion
Time Frame: 4 weeks after drug start
Check the WBC count in patient urine.
4 weeks after drug start
Urination frequency
Time Frame: 4 weeks after drug start
Checked for urination frequency at 4 weeks after drug start.
4 weeks after drug start
Recurrence
Time Frame: 6 months after drug start
Patients are checked for recurrence rate at 6 months after drug start by telephone interview.
6 months after drug start
urgency
Time Frame: 4 weeks after drug start
Check urgency 4 weeks after drug start
4 weeks after drug start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Institute of Disease Control and Prevention

Investigators

  • Principal Investigator: Zeliang Chen, Dr, Insititute of Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (Estimate)

December 10, 2012

Study Record Updates

Last Update Posted (Estimate)

December 10, 2012

Last Update Submitted That Met QC Criteria

December 7, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WJUTI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Urinary Tract Infection

Clinical Trials on LVX-AMX

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe