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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2012 by Beijing Institute of Disease Control and Prevention.
Recruitment status was Recruiting

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:

MedlinePlus related topics: Urinary Tract Infections

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

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

ClinicalTrials.gov processed this record on March 03, 2015

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