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

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: 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; Shanghai University of Traditional Chinese Medicine; Xiyuan Hospital of China Academy of Chinese Medical Sciences; Yunnan Provinical Hospital of Traditional Chinese Medicine
• Treatments: Levofloxacin; Ofloxacin

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.