NCT01745328

Brief Summary

Traditional Chinese Medicine (TCM) could be used to treat Recurrent urinary tract infection (RUTI).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 10, 2012

Status Verified

December 1, 2012

Enrollment Period

4.2 years

First QC Date

December 5, 2012

Last Update Submit

December 7, 2012

Conditions

Recurrent Urinary Tract Infection

Keywords

recurrent urinary tract infectionantibioticstraditional chinese medicine

Outcome Measures

Primary Outcomes (1)

  • Recovery of recurrent urinary tract infection

    Patients are checked at 4 weeks at the end of the treatment to confirm recovery of RUTI.

    4 weeks after study drug start

Secondary Outcomes (5)

  • Urinary albumin

    4 weeks after drug start

  • WBC conversion

    4 weeks after drug start

  • Urination frequency

    4 weeks after drug start

  • Recurrence

    6 months after drug start

  • urgency

    4 weeks after drug start

Study Arms (2)

LVX-AMX

ACTIVE COMPARATOR

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

Drug: LVX-AMX

TCM treatment

ACTIVE COMPARATOR

subject is treated with TCM

Drug: TCM

Interventions

LVX-AMXDRUG

Subjects were treated with Levofloxacin, 200mg bid, Amoxicillin, 500mg tid for 1 week, followed by 3 week of placebo.

Also known as: Levofloxacin, 200mg bid, Amoxicillin, 500mg tid
LVX-AMX
TCMDRUG

Subject is treated with TCM for 4 weeks.

Also known as: TCM formula consisted of 10 herbals
TCM treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • uncomplicated RUTI

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wangjing Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28741061DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

LevofloxacinBID protein, humanAmoxicillin

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur Compounds

Study Officials

  • Zeliang Chen, Dr

    Insititute of Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiwei Liu, Dr

CONTACT

86-10-84739029liushiwei1977@yeah.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 10, 2012

Study Start

January 1, 2009

Primary Completion

March 1, 2013

Study Completion

July 1, 2013

Last Updated

December 10, 2012

Record last verified: 2012-12

Locations

CN(1)