Abstract:

Background: Tuberculosis frequently manifests with symptoms including cough, sputum production, fatigue, anorexia, and weight loss. The first-line treatment regimens are often associated with adverse effects, notably hepatotoxicity and nephrotoxicity. Baidiziyin Pill and Shenqiyifei Pill exhibit properties that alleviate tuberculosis symptoms, possess anti-inflammatory effects, enhance cellular immune function, and offer hepatoprotective benefits. To date, no studies have investigated the application of Baidiziyin Pill and Shenqiyifei Pill as adjunctive therapies in conjunction with first-line anti-tuberculosis treatment. Methods: This study utilizes a multicenter randomized controlled trial design, focusing on patients newly diagnosed as susceptible pulmonary tuberculosis. Participants were randomly assigned to either an experimental group or a control group. Both groups received the standard first-line anti-tuberculosis treatment regimen, while the experimental group additionally received Baidiziyin Pill and Shenqiyifei Pill as adjunctive therapies. The primary objective is to compare symptom relief between the two groups, thereby evaluating the efficacy of Baidiziyin Pill and Shenqiyifei Pill in alleviating symptoms and mitigating adverse effects in patients undergoing first-line anti-tuberculosis treatment. Discussion: While this study does not evaluate the independent effects of the two drugs or their long-term therapeutic outcomes, it aims to optimize the treatment protocol for newly diagnosed pulmonary tuberculosis. The goal is to alleviate both respiratory and systemic symptoms associated with tuberculosis, as well as the adverse reactions resulting from anti-tuberculosis chemotherapy, ultimately improving the quality of life for affected patients. This research aspires to offer clinicians enhanced insights and strategies for the adjunctive use of traditional Chinese medicine in the treatment of tuberculosis.

Key words: Tuberculosis, Clinical therapeutic research, Traditional Chinese medicine, Controlled clinical trial, Clinical protocols