NCT03658291

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and immune mechanism of Sanjin tablets for the treatment of acute simple lower urinary tract infection and its influence on recurrence rate.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
252

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

July 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

July 24, 2018

Last Update Submit

November 22, 2018

Conditions

Urinary Tract Infection Lower Acute

Keywords

Sanjin tabletsefficacy and safetyrecurrence raterandomizeddouble blindparallel controlmulti-center clinical study

Outcome Measures

Primary Outcomes (1)

  • The lower urinary tract infection symptoms of 252 participants will be assessed

    The symptoms mainly includes frequent urination,urgent urination,urinary pain, lower abdominal pain and pain in the kidney area.If these symptoms disappear after 7 days of medication,it indicates the subject is cured.

    After 7 days of medication

Secondary Outcomes (5)

  • The urine leukocyte of 252 participants will be assessed

    After 7 days of medication

  • The bacteriological examination of 252 participants

    After 7 days of medication

  • The recurrence rate of subjects who is cured in 252 participants will be assessed by lower urinary tract infection symptoms

    28 days after the end of treatment

  • The recurrence rate of subjects who is cured in 252 participants will be assessed by urine leukocyte

    28 days after the end of treatment

  • The recurrence rate of subjects who is cured in 252 participants will be assessed by bacteriological examination

    28 days after the end of treatment

Study Arms (3)

Sanjin tablets group

EXPERIMENTAL

Sanjin tablets+ levofloxacin simulants

Drug: Sanjin tablets

Levofloxacin group

PLACEBO COMPARATOR

Sanjin tablets simulants +levofloxacin

Drug: Sanjin tablets simulants

Sanjin tablets+ Levofloxacin group

ACTIVE COMPARATOR

Sanjin tablets+ levofloxacin

Drug: Levofloxacin

Interventions

Sanjin tabletsDRUG

Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin simulants,0.1g, po bid, for 7 days.

Also known as: levofloxacin simulants
Sanjin tablets group
Sanjin tablets simulantsDRUG

levofloxacin ,0.1g, po bid, for 7 days+Sanjin tablets simulants,3 pills /time, 4 times/ day, for 7 days.

Also known as: Levofloxacin
Levofloxacin group
LevofloxacinDRUG

Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin,0.1g, po bid, for 7 days.

Also known as: Sanjin tablets
Sanjin tablets+ Levofloxacin group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects aged 18 to 50 years of age.
  • Meets the western diagnostic criteria of acute simple lower urinary tract infection, the disease duration does not exceed 72 hours.
  • Urine retention in the screening period -1-0 days, bacterial culture results were sensitive to levofloxacin.(Urine retention for bacterial culture and clinical treatment at the same time)
  • The syndrome differentiation of TCM is syndrome of dampness-heat in lower jiao.
  • Did not receive antibiotic treatment within 48 hours Before being selected.
  • Those who agree to participate in this clinical trial and sign the informed consent, the process of informed consent meet the relevant provisions of the GCP.

You may not qualify if:

  • Those who are allergic to the test drug ingredients or quinolones.
  • In the past, there was a history of bacterial culture that was not sensitive to levofloxacin.
  • Diagnosed as complicated urinary tract infection.
  • Patients with urinary calculi or obstruction, urinary tuberculosis, renal papillary necrosis, perinephric abscess or neurogenic bladder.
  • Combined with vaginitis symptoms, genital ulcers or gonorrhea.
  • Combined with severe cardiopulmonary disease, liver and kidney disease, advanced tumor, blood, central nervous system (such as the history of epilepsy) or other serious or progressive disease.
  • A patient who has a neurological or mental illness and cannot cooperate.
  • Infected persons who must use other antibacterial drugs in combination.
  • Pregnancy, lactating women or recent birth planners.
  • Those who have participated in other clinical trials within 3 months before being selected.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lyu J, Xie YM, Gao Z, Shen JW, Deng YY, Xiang ST, Gao WX, Zeng WT, Zhang CH, Yi DH, Wang LX, Wang ZF. Sanjin tablets for acute uncomplicated lower urinary tract infection (syndrome of dampness-heat in the lower jiao): protocol for randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical trial. Trials. 2019 Jul 19;20(1):446. doi: 10.1186/s13063-019-3539-5.

    PMID: 31324199DERIVED

MeSH Terms

Interventions

Levofloxacin

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Yanming Xie, BA

    Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanming Xie, BA

CONTACT

86-13911112416ktzu2018@163.com

Lianxin Wang, Doctor

CONTACT

86-13521781839wlxing@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director

Study Record Dates

First Submitted

July 24, 2018

First Posted

September 5, 2018

Study Start

January 1, 2019

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

November 26, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share