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
Recruitment status was Recruiting
Sponsor:
Beijing Institute of Disease Control and Prevention
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
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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 (Adult, Senior) |
| 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
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
| 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:
|
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 |
ClinicalTrials.gov processed this record on September 27, 2016