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Clinical Study of Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection

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ClinicalTrials.gov Identifier: NCT03658291
Recruitment Status : Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : November 26, 2018
Sponsor:
Collaborators:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Guangdong Provincial Hospital of Traditional Chinese Medicine
Hubei Hospital of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
Yunnan Provinical Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Lower Acute Drug: Sanjin tablets Drug: Sanjin tablets simulants Drug: Levofloxacin Phase 4

Detailed Description:
In order to evaluating 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 and through research data to guide clinical, improving the rational use of drugs, especially the rational application of antibiotics. In this study, a randomized, double blind, parallel control of positive drugs, multi-center clinical study will be established. According to the relevant regulations of the CFDA, 252 cases need to be registered at least. These cases will be divided into treatment group(Sanjin tablets+ levofloxacin simulants),control group 1(Sanjin tablets simulants +levofloxacin)and control group 2(Sanjin tablets+ levofloxacin). Each group will be treated for 7 days and followed up for 2 times. The efficacy indicators of this study were mainly from three dimensions: syndrome, laboratory routine examination and bacteriology examination. The symptom scores and cytokine changes of each group before and after treatment were observed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection and Its Influence on Recurrence Rate: a Randomized, Double Blind, Parallel Control of Positive Drugs, Multi-center Clinical Study
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sanjin tablets group
Sanjin tablets+ levofloxacin simulants
Drug: Sanjin tablets
Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin simulants,0.1g, po bid, for 7 days.
Other Name: levofloxacin simulants

Placebo Comparator: Levofloxacin group
Sanjin tablets simulants +levofloxacin
Drug: Sanjin tablets simulants
levofloxacin ,0.1g, po bid, for 7 days+Sanjin tablets simulants,3 pills /time, 4 times/ day, for 7 days.
Other Name: Levofloxacin

Active Comparator: Sanjin tablets+ Levofloxacin group
Sanjin tablets+ levofloxacin
Drug: Levofloxacin
Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin,0.1g, po bid, for 7 days.
Other Name: Sanjin tablets




Primary Outcome Measures :
  1. The lower urinary tract infection symptoms of 252 participants will be assessed [ Time Frame: After 7 days of medication ]
    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.


Secondary Outcome Measures :
  1. The urine leukocyte of 252 participants will be assessed [ Time Frame: After 7 days of medication ]
    If the urine leukocyte return to normal value after 7 days of medication,it indicates the subject is cured.

  2. The bacteriological examination of 252 participants [ Time Frame: After 7 days of medication ]
    If the original infected part of the specimen did not regenerate the original infected pathogen after 7 days of medication,it indicates the subject is cured.

  3. The recurrence rate of subjects who is cured in 252 participants will be assessed by lower urinary tract infection symptoms [ Time Frame: 28 days after the end of treatment ]
    If the lower urinary tract infection symptoms of subjects who is cured appears again in the fourth week after end of medication,it indicates the subject has relapsed.

  4. The recurrence rate of subjects who is cured in 252 participants will be assessed by urine leukocyte [ Time Frame: 28 days after the end of treatment ]
    If the urine leukocyte value of subjects who is cured rises again in the fourth week after end of medication,it indicates the subject has relapsed.

  5. The recurrence rate of subjects who is cured in 252 participants will be assessed by bacteriological examination [ Time Frame: 28 days after the end of treatment ]
    If the urine culture of subjects who is cured indicates that the original urinary tract pathogen is positive again in the fourth week after end of medication,it indicates the subject has relapsed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects aged 18 to 50 years of age.
  2. Meets the western diagnostic criteria of acute simple lower urinary tract infection, the disease duration does not exceed 72 hours.
  3. 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)
  4. The syndrome differentiation of TCM is syndrome of dampness-heat in lower jiao.
  5. Did not receive antibiotic treatment within 48 hours Before being selected.
  6. The inclusion of those who confirmed not pregnant
  7. 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.

Exclusion Criteria:

  1. Those who are allergic to the test drug ingredients or quinolones.
  2. In the past, there was a history of bacterial culture that was not sensitive to levofloxacin.
  3. Diagnosed as complicated urinary tract infection.
  4. Patients with urinary calculi or obstruction, urinary tuberculosis, renal papillary necrosis, perinephric abscess or neurogenic bladder.
  5. Combined with vaginitis symptoms, genital ulcers or gonorrhea.
  6. 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.
  7. A patient who has a neurological or mental illness and cannot cooperate.
  8. Infected persons who must use other antibacterial drugs in combination.
  9. Pregnancy, lactating women or recent birth planners.
  10. Those who have participated in other clinical trials within 3 months before being selected.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658291


Contacts
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Contact: Yanming Xie, BA 86-13911112416 ktzu2018@163.com
Contact: Lianxin Wang, Doctor 86-13521781839 wlxing@126.com

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Guangdong Provincial Hospital of Traditional Chinese Medicine
Hubei Hospital of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
Yunnan Provinical Hospital of Traditional Chinese Medicine
Investigators
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Principal Investigator: Yanming Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

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Responsible Party: Yanming Xie, Deputy director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03658291     History of Changes
Other Study ID Numbers: Sanjin tablets
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yanming Xie, China Academy of Chinese Medical Sciences:
Sanjin tablets
efficacy and safety
recurrence rate
randomized
double blind
parallel control
multi-center clinical study

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Anti-Infective Agents, Urinary
Urologic Diseases
Levofloxacin
Ofloxacin
Anti-Infective Agents
Renal Agents
Anti-Bacterial 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