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

Primary Purpose

Recurrent Urinary Tract Infection

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LVX-AMX
TCM
LVX-AMX
Sponsored by
Beijing Institute of Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Urinary Tract Infection focused on measuring recurrent urinary tract infection, antibiotics, traditional chinese medicine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • uncomplicated RUTI

Exclusion Criteria:

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

Sites / Locations

  • Wangjing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LVX-AMX

TCM treatment

Arm Description

subject is treated with LAV-AMX, then followed by placebo.

subject is treated with TCM

Outcomes

Primary Outcome Measures

Recovery of recurrent urinary tract infection
Patients are checked at 4 weeks at the end of the treatment to confirm recovery of RUTI.

Secondary Outcome Measures

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

Full Information

First Posted
December 5, 2012
Last Updated
December 7, 2012
Sponsor
Beijing Institute of Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01745328
Brief Title
Treatment of Recurrent Urinary Tract Infection (RUTI) by Traditional Chinese Medicine
Official Title
Study on Treatment of Recurrent Urinary Tract Infection by Traditional Chinese Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Institute of Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Traditional Chinese Medicine (TCM) could be used to treat Recurrent urinary tract infection (RUTI).
Detailed Description
Antibiotics and TCM are used to treat RUTI to evaluate treatment efficiencies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection
Keywords
recurrent urinary tract infection, antibiotics, traditional chinese medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LVX-AMX
Arm Type
Active Comparator
Arm Description
subject is treated with LAV-AMX, then followed by placebo.
Arm Title
TCM treatment
Arm Type
Active Comparator
Arm Description
subject is treated with TCM
Intervention Type
Drug
Intervention Name(s)
LVX-AMX
Other Intervention Name(s)
Levofloxacin, 200mg bid, Amoxicillin, 500mg tid
Intervention Description
Subjects were treated with Levofloxacin, 200mg bid, Amoxicillin, 500mg tid for 1 week, followed by 3 week of placebo.
Intervention Type
Drug
Intervention Name(s)
TCM
Other Intervention Name(s)
TCM formula consisted of 10 herbals
Intervention Description
Subject is treated with TCM for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
LVX-AMX
Other Intervention Name(s)
placebo from 2 to 4 weeks.
Intervention Description
treatment with placebo from 2 to 4 weeks.
Primary Outcome Measure Information:
Title
Recovery of recurrent urinary tract infection
Description
Patients are checked at 4 weeks at the end of the treatment to confirm recovery of RUTI.
Time Frame
4 weeks after study drug start
Secondary Outcome Measure Information:
Title
Urinary albumin
Description
Urinary albumin is checked in patient urine.
Time Frame
4 weeks after drug start
Title
WBC conversion
Description
Check the WBC count in patient urine.
Time Frame
4 weeks after drug start
Title
Urination frequency
Description
Checked for urination frequency at 4 weeks after drug start.
Time Frame
4 weeks after drug start
Title
Recurrence
Description
Patients are checked for recurrence rate at 6 months after drug start by telephone interview.
Time Frame
6 months after drug start
Title
urgency
Description
Check urgency 4 weeks after drug start
Time Frame
4 weeks after drug start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: uncomplicated RUTI Exclusion Criteria: complicated RUTI other disease with urinary tract infection by pathogens other than bacteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiwei Liu, Dr
Phone
86-10-84739029
Email
liushiwei1977@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeliang Chen, Dr
Organizational Affiliation
Insititute of Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wangjing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiwei Liu, Dr
Phone
86-10-84739029
Email
liushiwei1977@yeah.net
First Name & Middle Initial & Last Name & Degree
Shiwei Liu, Dr

12. IPD Sharing Statement

Citations:
PubMed Identifier
28741061
Citation
Liu SW, Guo J, Wu WK, Chen ZL, Zhang N. Treatment of Uncomplicated Recurrent Urinary Tract Infection with Chinese Medicine Formula: A Randomized Controlled Trial. Chin J Integr Med. 2019 Jan;25(1):16-22. doi: 10.1007/s11655-017-2960-4. Epub 2017 Jul 25.
Results Reference
derived

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

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