Effects of Ziziphus jujuba on the Prevention of Drug Induced Liver Enzyme Disorders in Pulmonary Tuberculosis Patients: Protocol for Randomized controlled trial

Liver damage is the most common complication of anti-tuberculosis drugs, but there is currently no standard prevention for it. The main purpose of this study is to determine the effectiveness of Ziziphus jujuba (Z. jujuba) syrup on the prevention of liver enzyme disorder in TB patients. This study was a protocol for randomized controlled trial. 48 patients were included in the study who were randomly assigned to one of the two groups of jujube syrup or placebo syrup based on the block randomization. Liver enzyme tests were measured at the beginning of the study, as well as days 14 and 28 of the study, which were the primary outcome. The standard Visual Analog Scales questionnaire were completed on days 0, 14, and 28 to assess cough, anorexia, and nausea in patients. The standard SF-36 quality of life questionnaire were completed on days 0 and 28 of the study, which would be evaluated as the secondary outcome of the study. The hypothesis of the study is that the incidence rate of liver enzyme disorder would be lower in patients treated with jujube syrup, compared to those who received the placebo.