Recurrent Urinary Tract InfectionNCT01745328
Treatment of Recurrent Urinary Tract Infection (RUTI) by Traditional Chinese Medicine
A study testing LVX-AMX and TCM in people with Recurrent Urinary Tract Infection, run by Beijing Institute of Disease Control and Prevention at 1 site in China.
Trial summary
Traditional Chinese Medicine (TCM) could be used to treat Recurrent urinary tract infection (RUTI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- LVX-AMX and TCM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- uncomplicated RUTI
Who cannot join
- complicated RUTI
- other disease with urinary tract
- infection by pathogens other than bacteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wangjing Hospital
Beijing, Beijing Municipality, 100020
Shiwei Liu, Dr, 86-10-84739029, liushiwei1977@yeah.net
Shiwei Liu, Dr
About this study
Official title: 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).
Read the detailed description
Antibiotics and TCM are used to treat RUTI to evaluate treatment efficiencies.
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- LVX-AMX, TCM
- Keywords
- recurrent urinary tract infection, antibiotics, traditional chinese medicine
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVX-AMXDrug
Also called Levofloxacin, 200mg bid, Amoxicillin, 500mg tid
Subjects were treated with Levofloxacin, 200mg bid, Amoxicillin, 500mg tid for 1 week, followed by 3 week of placebo.
TCMDrug
Also called TCM formula consisted of 10 herbals
Subject is treated with TCM for 4 weeks.
LVX-AMXDrug
Also called placebo from 2 to 4 weeks.
treatment with placebo from 2 to 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| LVX-AMX | Active comparator | subject is treated with LAV-AMX, then followed by placebo. Receives: Drug: LVX-AMX |
| TCM treatment | Active comparator | subject is treated with TCM Receives: Drug: TCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of recurrent urinary tract infection
Patients are checked at 4 weeks at the end of the treatment to confirm recovery of RUTI.
Measured: 4 weeks after study drug start
Secondary outcomes (5)
Urinary albumin
Urinary albumin is checked in patient urine.
Measured: 4 weeks after drug start
WBC conversion
Check the WBC count in patient urine.
Measured: 4 weeks after drug start
Urination frequency
Checked for urination frequency at 4 weeks after drug start.
Measured: 4 weeks after drug start
Recurrence
Patients are checked for recurrence rate at 6 months after drug start by telephone interview.
Measured: 6 months after drug start
urgency
Check urgency 4 weeks after drug start
Measured: 4 weeks after drug start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startJan 2009
- Primary completionMar 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Disease Control and Prevention
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeliang Chen, Dr, Principal investigator, Insititute of Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745328
- Sponsor's protocol ID
- WJUTI
- Status last verified
- Dec 2012
- First submitted
- 5 Dec 2012
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28741061
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Treatment of Recurrent Urinary Tract Infection by Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT01745328
- Acronym / sponsor ID
- WJUTI
- Conditions
- Recurrent Urinary Tract Infection
- Keywords
- recurrent urinary tract infection, antibiotics, traditional chinese medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Institute of Disease Control and PreventionUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LVX-AMX | Active comparator | Drug: LVX-AMXsubject is treated with LAV-AMX, then followed by placebo. |
| TCM treatment | Active comparator | Drug: TCMsubject is treated with TCM |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- uncomplicated RUTI
Key exclusion criteria (3 listed)
- complicated RUTI
- other disease with urinary tract
- infection by pathogens other than bacteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LVX-AMXAlso: Levofloxacin, 200mg bid, Amoxicillin, 500mg tidSubjects were treated with Levofloxacin, 200mg bid, Amoxicillin, 500mg tid for 1 week, followed by 3 week of placebo. | Drug | LVX-AMX |
| TCMAlso: TCM formula consisted of 10 herbalsSubject is treated with TCM for 4 weeks. | Drug | TCM treatment |
| LVX-AMXAlso: placebo from 2 to 4 weeks.treatment with placebo from 2 to 4 weeks. | Drug | LVX-AMX |
Primary outcome
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.
5 secondary outcomes
Urinary albumin
Time frame: 4 weeks after drug start
WBC conversion
Time frame: 4 weeks after drug start
Urination frequency
Time frame: 4 weeks after drug start
Recurrence
Time frame: 6 months after drug start
urgency
Time frame: 4 weeks after drug start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
- Derived from this study: PubMed 28741061Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeliang Chen, Dr principal investigator
Insititute of Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LVX-AMX and TCM in people with Recurrent Urinary Tract Infection, run by Beijing Institute of Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiwei Liu, Dr (86-10-84739029, liushiwei1977@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of recurrent urinary tract infection (time frame: 4 weeks after study drug start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01745328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2012.