A Randomized Controlled Clinical Study on Treatment of Acute Simple Urinary Tract Infection of Xiajiao Damp-Heat Type with Niaogan Fang

Phase 1

• Conditions: rinary Tract Infection

• Registration Number: ITMCTR2000004035
• Lead Sponsor: Shanghai Traditional Chinese Medicine Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Aged 18 to 50 years old;
(2) Meet the Western diagnostic criteria for UTI under acute uncomplicated conditions, that is, the duration of the disease does not exceed 72 hours;
(3) The result of bacterial culture is levofloxacin sensitive (bacterial culture and clinical treatment will be carried out at the same time);
(4) TCM differentiation is Xiajiao damp-heat syndrome;
(5) Did not receive antibiotic treatment within 48 hours before being selected;
(6) Not pregnant or breastfeeding;
(7) Sign the written informed consent of the clinical trial.

Exclusion Criteria

(1) Allergy to test drugs or quinolones;
(2) Have a history of bacterial culture that is not sensitive to levofloxacin;
(3) Diagnosed as complicated UTI disease;
(4) Patients suffering from urinary calculi or obstruction, urinary tuberculosis, renal papillary necrosis, perinephric abscess or neurogenic bladder;
(5) Accompanied by symptoms of vaginitis, genital ulcers or gonorrhea;
(6) Combined with severe heart and lung disease, liver and kidney disease, advanced tumor and other serious or progressive diseases;
(7) Suffer from neurological or mental illness, unable to cooperate;
(8) Combined use of other antibacterial drugs;
(9) Women who are pregnant, breastfeeding, or planning to become pregnant;
(10) Participate in another clinical trial within three months before being selected.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Actual efficiency;Urine routine;

Secondary Outcome Measures

Name	Time	Method
Recurrence rate;