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

China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Urinary Tract Infection Lower Acute

Treatments: Drug: Sanjin tablets simulants; Drug: Levofloxacin; Drug: Sanjin tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT03658291

Sanjin tablets

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 3 patient groups, including a placebo group

Sanjin tablets group

Experimental group

Description:

Sanjin tablets+ levofloxacin simulants

Treatment:

Drug: Sanjin tablets

Levofloxacin group

Placebo Comparator group

Description:

Sanjin tablets simulants +levofloxacin

Treatment:

Drug: Sanjin tablets simulants

Sanjin tablets+ Levofloxacin group

Active Comparator group

Description:

Sanjin tablets+ levofloxacin

Treatment:

Drug: Levofloxacin