Primary outcome measures
Antibiotic use rate and clinical cure rate
Secondary outcome measures
Time to antibiotic intervention, effectiveness, and treatment course.
Abnormal liver and kidney functions, electrocardiogram, and other results; allergic symptoms such as drug fever, allergic reactions, anaphylactic shock, or skin rash; severe vomiting, diarrhea, and other digestive system symptoms; cough, chest tightness, shortness of breath, and other respiratory symptoms; and all adverse events that occurred in the trial.
Record the time, duration, extent, and treatment of adverse reactions. Evaluate its relevance to treatment.
The computer software CDMS is used to establish the corresponding entry procedure and establish a special database system for this tials. Data entry adopts the double entry method, which is completed by two persons independently. Data review uses the verification function in computer software for logical inspection and automatic comparison. After the data is locked, the unit that saves the blind file submits the blind file to the data manager, and the data manager completes the unblinding of the data. The unblinded data is handed over to statistical analysts for analysis. Data that is significantly outside the clinically acceptable range must be verified, and the investigator must provide the necessary explanations.
After the completion of the trial, the informed consent form and the subject's signature code form will be kept by each hospital. The clinical trial data will be kept until 5 years after the termination of the clinical trial.
Statistical analysis will be carried out using SAS 9.4 or above. According to the data characteristics, measured data will be analyzed by independent sample t-tests or rank sum tests for comparison between groups and numerical data will be analyzed by χ2or Fisher’s exact probability tests. Laboratory data for all clinical endpoints will be analyzed according to intention to treat (ITT) and compliance (PP) analyses, and safety analysis will be performed using a safety data set (SS).The efficacy scores at the time of patient enrollment, intermediate follow-up (day 3, day 4 to day 7 after treatment), and at the end point of the trial will be calculated, and the mean, standard deviation, median, P5, P75, maximum and minimum values of the differences in values between baseline and the treatment period will be used. PP and ITT will be adopted to analyze the main index and overall index. Subjects with positive urine culture indicators will be included in the statistical subgroup to analyze the correlation between the study program and the overall efficacy evaluation index. Because this is a multicenter, randomized, double-blind controlled trial, the possible central effect on efficacy indicators should be considered.
We calculated the sample size according to our primary study. We found that the use rate of antibiotics in the two groups of patients treated with traditional Chinese medicine was 46%, and that of the control group was 80%. Calculate the sample size under the settings of α= 0.05 and β= 0.80. The grouping ratio is 1:1:1. Calculate the single group n=37, so there are 111 cases in the three groups. Taking into account a drop-out of 10%, In the end, we set the number of cases to 120.
Randomization and allocation
Taking the center as the unit, the patients were divided into an experimental group and a control group according to the stratified randomization principle. (Through the "central code allocation random number" sequence of SAS statistical software, the random code of each center is obtained, and the research center is randomly assigned through the random code.)
Personnel were blinded to the scale evaluation, data collection, laboratory index testing, and statistics.
Design a patient diary to collect information on study medication management, symptom assessment, and adverse events.
An independent inspection center was established, and the inspection center appointed inspectors to conduct systematic inspections of trial-related activities and documents.
All information about this trial must be kept strictly confidential, and documents that can show the identity of the subject are kept strictly confidential.