Clinical trial project of traditional chinese and western medicine for severe and difficult diseases (liver fibrosis) - clinical efficacy evaluation of ruogan huoxue recipe in the treatment of chronic hepatitis b liver fibrosis

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

暂无简介。

•1.Patients meeting the diagnostic criteria for hepatic fibrosis in chronic hepatitis b;
•2.The pathological results of liver biopsy showed that Ishak stage was F2-F6 (all patients needed liver biopsy before and after treatment);
•3.Initial patients ( HBeAg-positive patients, HBV-DNA > 20000IU/ml (equivalent to 10E5 copies/ml); HBeAg-negative patients, HBV-DNA > 2000IU/ml (equivalent to 10E4 copies/ml) or those who have used entecavir, tenofovir (ester) or other antiviral drugs for more than one year and whose HBV-DNA is below the detection limit;
•4.Willing to accept integrated Chinese and Western medicine treatment;
•5.The age ranges from 18 to 65 years, with no gender limitation.
•6.Signing an informed consent.

•(1) Patients with hepatitiscaused by other hepatophilic viruses, steatohepatitis, autoimmune hepatitis, alcoholic liver disease and long-term history of traditional Chinese and Western medicine taking hepatotoxicity.
•(2) The patients with decompensated cirrhosis, such as those with Child-Pugh C grade > 12 points, had upper gastrointestinal bleeding, hepatic encephalopathy, intractable ascites, hemorrhagic tendency, hepatorenal syndrome and primary hepatocellular carcinoma in the past six months.
•(3) Patients with abnormal AFP and/or liver and spleen B ultrasound or CT or MRI suspicious liver space occupancy.
•(4) Patients with severe primary diseases of heart, kidney, lung, endocrine, blood, metabolism and gastrointestinal tract; or psychiatric patients.
•(5) Patients with allergic constitution or allergic to various drugs.
•(6) Pregnant women or breast-feeding women who are willing to have children in the near future.
•(7) Patients who used immunomodulators systematically in the past six months.
•(8) Loss of Fibroscan or Fibrotouch detection due to obesity (BMI > 30), narrow costal space and other factors

发起方

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine