Efficacy and Safety of a Chinese Herbal Formula (Invigorating Kidney and Strengthening Spleen) in Chronic Hepatitis B Virus Carrier: Results from a Multicenter, Randomized, Double-Blind, and Placebo-Controlled Trial

Table 1

Inclusion and exclusion criteria of patients.

Inclusion criteria	Exclusion criteria
Conform with the diagnostic criteria of chronic hepatitis B carriers	Inactive HBsAg (+) carriers
Conform with the pathogenesis and syndromes of kidney deficiency and spleen deficiency	Serum α-fetoprotein abnormal
Age 20–65 y	Pregnancy or breast feeding
ALT ≤ 40 IU/L	Coinfection with HIV, HCV, HDV
HBV DNA > 100,000 IU/mL	Histologic evidence of cirrhosis
Liver biopsy before treatment indicates mild inflammatory necrosis and fibrosis	Evidence of any other chronic liver disease
Sign informed consent and participate in this clinical trial voluntarily	Mental illness or any other serious systemic illness; Antivirus treatment with nucleoside or interferon-α within 6 months; Abuse alcohol or illegal drugs; Allergic to the drug ingredients