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

Urinary Tract Infection Lower Acute Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03658291
• Other study ID #: Sanjin tablets
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2018
• Source: China Academy of Chinese Medical Sciences
• Contact: Yanming Xie, BA
• Phone: 86-13911112416
• Email: ktzu2018[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 252
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection Lower Acute
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Chengdu University of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Yunnan Provinical Hospital of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The urine leukocyte of 252 participants will be assessed	If the urine leukocyte return to normal value after 7 days of medication,it indicates the subject is cured.	After 7 days of medication
Secondary	The bacteriological examination of 252 participants	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.	After 7 days of medication
Secondary	The recurrence rate of subjects who is cured in 252 participants will be assessed by lower urinary tract infection symptoms	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.	28 days after the end of treatment
Secondary	The recurrence rate of subjects who is cured in 252 participants will be assessed by urine leukocyte	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.	28 days after the end of treatment
Secondary	The recurrence rate of subjects who is cured in 252 participants will be assessed by bacteriological examination	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.	28 days after the end of treatment