1. Project Background Chronic hepatitis C is an infectious disease caused by the infection of the hepatitis C virus (HCV). There are over 5.6 million HCV-infected individuals in China. After HCV infection, up to 80% of patients may develop chronic infection, with cirrhosis and liver cancer being the main causes of death. The prevention and treatment of hepatitis C have become a serious social and public health issue. Traditional Chinese medicine (TCM), with its individualized treatment based on syndrome differentiation, has shown its uniqueness in the treatment of chronic hepatitis C. How to further embody and explore these advantages of TCM treatment, and how to form a safe and effective combined traditional Chinese and Western medical treatment plan for chronic hepatitis C that can be promoted and used, requires more standardized research based on evidence-based medicine principles to verify. 2. Main Content This project relies on the national Eleventh Five-Year Science and Technology Major Project undertaken by the project team. In response to the current standard treatment regimens that have shortcomings such as poor viral response and high relapse rates after discontinuation, this study aims to further improve the HCV seroconversion rate by exploring and investigating the potential therapeutic effects of traditional Chinese medicine (TCM)/integrated TCM-Western medicine. The main research content is divided into two parts: The first part involves a multicenter, large-sample research method that combines expert blind judgment with modern mathematical statistics to clarify the standardized differentiation and typing of chronic hepatitis C; the second part uses a multicenter, randomized, double-blind, placebo-controlled prospective research method to observe the efficacy and safety of the Fuzheng Jiedu decoction combined with the standard treatment regimen for chronic hepatitis C. 3. Key Innovations This project is the first in China to adopt a multicenter, large-sample survey approach to study the characteristics of TCM syndromes in chronic hepatitis C. Following the concept of 'Evidence-Based Medicine,' it draws on DEM (Design, Methods, and using EDC (Electronic Data Communication), through an epidemiological and TCM syndrome survey of 1241 patients with chronic hepatitis C, organically combined expert blind judgment with modern mathematical statistics and computer pattern discrimination, preliminarily clarified the distribution rules of Chinese chronic hepatitis C TCM syndromes, standardized diagnostic typing, and characterized the condition of Chinese chronic hepatitis C, providing ideas for the research on TCM syndromology. This project is the first in China to adopt a multi-center, large sample, randomized, blinded, placebo-controlled method to verify the efficacy of a clinical treatment plan combining traditional Chinese medicine and Western medicine for chronic hepatitis C. The key indicator (HCV RNA) was tested by a third party, and the research methods were strictly conducted according to evidence-based medicine principles, which will provide beneficial exploration for the standardization and internationalization of TCM research. The results show that The sustained virological response rate (SVR) of the integrated traditional Chinese and Western medicine treatment regimen has increased by 14%, significantly outperforming the standard treatment alone, especially for SVR in patients with Qi deficiency and lingering pathogenic factors, damp-heat obstruction, and liver depression and spleen deficiency types. In addition, the Fuzheng Jiedu prescription can improve symptom scores and alleviate the bone marrow suppression side effects of the standard treatment regimen, to some extent improving patient compliance. A clinical case information database and serum bank for chronic hepatitis C have been established in China. 4. Application and Promotion The diagnostic classification standards and integrated traditional Chinese and Western medicine treatment regimens formed in this project study are currently being promoted and applied in 18 research centers across 10 provinces and cities nationwide, and further used within the Shanghai TCM industry and the national TCM liver disease collaboration group. Through the research, A preliminary research backbone team and clinical research network engaged in the prevention and treatment of chronic hepatitis C with traditional Chinese medicine (TCM) have been formed across 10 provinces, municipalities, and autonomous regions of China's southeast, northwest, and southwest. The research results include 24 published papers, 3 of which were included in SCI journals, 8 presentations at domestic and international conferences, and a total of 25 graduate students trained. 5. Social Benefits The TCM syndrome norms established by this project provide a theoretical basis for a deeper understanding of the TCM pathogenesis characteristics of hepatitis C, which is conducive to simplifying complex clinical syndrome differentiation and treatment processes. Ultimately, it contributes to improving clinical efficacy and reducing mortality rates. The integrated TCM and Western medicine treatment plan formed by this project has increased SVR by 14%, which will further improve the clinical efficacy of hepatitis C patients in China.