Exploring the Impact of Nephropathy Formula No. 1 on Chronic Kidney Disease Patients

Sample Size Estimation Sample size estimation is based on the results of a pilot study. A total of 60 patients are required for enrollment. Considering a dropout rate of 10%-15%, each group will need 35 cases, with a total of 70 cases for both groups. Patient Recruitment Patients will be recruited by researchers during outpatient or inpatient visits. After screening according to the inclusion and exclusion criteria, eligible patients will be enrolled in the study following the signing of the informed consent form. Adverse Events and Serious Adverse Events Management Severity: Physicians can use the following definitions to judge the severity of all adverse events and serious adverse events, which will serve as endpoints/data cutoff points for the study. Mild: Adverse events are transient and easily tolerated by the patient. Moderate: Adverse events cause discomfort to the subject and interfere with their normal activities. Severe: Adverse events significantly impact the subject's daily activities and may result in functional loss or be life-threatening. Management of Adverse Events: In the clinical trial, if any adverse event occurs, regardless of its causal relationship with the investigational drug or the treatment method used, the researcher must take necessary measures for treatment and rescue. For adverse events that occur during the trial, the type, severity, onset time, duration, management measures, and course of action should be recorded in the inpatient medical record and the case report form. A comprehensive analysis should be conducted to determine whether the event is related to the trial. After an adverse event occurs, the researcher may decide whether the subject should discontinue the clinical trial based on the condition. For cases terminated due to serious adverse events, follow-up and recording of their outcomes should be conducted. Recording and Reporting of Serious Adverse Events: If a serious adverse event occurs during the trial, regardless of its relationship to the trial, immediate emergency measures should be taken, and the principal investigator and the ethics committee should be notified by phone within 24 hours. Subsequently, a serious adverse event report form should be completed and promptly submitted to the aforementioned departments. Monitoring and Recording of Adverse Events This includes any symptoms, signs, and laboratory abnormalities that occur from the time of signing the informed consent form to the end of the last visit. The occurrence of adverse events should be specifically described, including the time of occurrence, severity, duration, measures taken, and outcome. All adverse events should be recorded in the designated case report form for adverse events. Data Management Researchers are required to fill in the collected data into the case report form according to the study protocol and use EXCEL software for data collection or recording. Data management will be handled by a designated person to ensure the authenticity, completeness, and accuracy of the clinical trial data. At the end of the study, researchers will submit all the case report forms of the enrolled patients to the data management center. These case report forms should be complete and signed. Consistency of data collected from various research centers will be checked, and queries will be issued for any inconsistencies, which the researchers will need to clarify. Missing data will be preserved but not included in the statistical analysis. Data Description Quantitative data will be described using mean ± standard deviation (SD), median, maximum, minimum, and quartiles. Categorical data will be represented as percentages (%). Data Statistics All statistical tests, unless otherwise specified, will use a two-sided test. A P-value of less than 0.05 will be considered statistically significant. Comparisons of general conditions among groups will be analyzed using appropriate methods based on data type and distribution. For example, comparisons of quantitative indicators between groups will use one-way analysis of variance (ANOVA) (for homoscedasticity and normal distribution) or the Kruskal-Wallis rank-sum test (for non-normal distribution); categorical indicators will use the chi-square test or Fisher's exact test (if the chi-square test is not applicable), and ordinal indicators will use the Kruskal-Wallis rank-sum test or the Cochran-Mantel-Haenszel (CMH) test. A P-value of less than 0.05 will be considered statistically significant. Statistical Analysis Plan This will be completed by professional statisticians. After all data entry and review are completed, statisticians should promptly conduct the statistical analysis and produce a written statistical analysis report.