A randomized, double-blind, loading, placebo-controlled, multicenter clinical study on the efficacy and safety of Polyporus polysaccharide capsule combined with entecavir in the treatment of low-level

Authors
Category Primary study
Registry of TrialsITMCTR
Year 2022
INTERVENTION: Control group:Routine treatment + Polyporus polysaccharide capsule simulation agent;Test group:Routine treatment + Polyporus polysaccharide capsule ; CONDITION: Low level viremia of chronic hepatitis B PRIMARY OUTCOME: The magnitude of the subject's serum HBV DNA decline; SECONDARY OUTCOME: Change of TCM syndrome score of subjects;Incidence of HBeAg‐negative and HBEAB‐positive seroconversion in subjects (%);Incidence of negative serum HBVDNA in subjects (%);Incidence of HBsAg negative serum in subjects (%);The quantitative reduction of serum HBsAg in subjects; INCLUSION CRITERIA: Inclusion criteria The following criteria must be met before entering the study: (1) It complies with the guidelines for the prevention and treatment of chronic hepatitis B (2019 Edition) prepared and revised by the infectious diseases branch of the Chinese Medical Association and the hepatology branch of the Chinese Medical Association, and is clinically diagnosed as a patient with chronic hepatitis B; (2) TCM syndrome differentiation is liver and gallbladder damp heat syndrome; (3) The age is 18 70 years old (including upper and lower limits), and the se Xis unlimited; (4) The subjects of childbearing age are willing to start from the date of signing the informed consent form to 3 months after the last administration Willing to take adequate contraceptive measures and agree to use non drug complete contraception during the study period; (5) Antiviral therapy with entecavir for at least 6 months;
Epistemonikos ID: 863bcf612ec03b94ebe01028004267ff443600e8
First added on: Aug 26, 2024