drugset / Trial / NCT06403943

Summary

This study is designed to further strengthen the clinical application evidence of BaidiZiyin Pill and ShenqiYifei Pill in the treatment of tuberculosis. To be included in the initial treatment of pulmonary tuberculosis patients, on the basis of standardized Western medicine treatment, BaidiZiyin Pills and ShenqiYifei Pills will be used to evaluate the clinical efficacy and safety of their products. 1. Evaluate the improvement of symptoms in the adjuvant treatment of newly treated pulmonary tuberculosis with BaidiZiyin Pill and ShenqiYifei Pill. 2. Explore the sputum negative conversion time and sputum negative conversion rate of BaidiZiyin Pill and ShenqiYifei Pill as adjunctive treatments for newly treated pulmonary tuberculosis. 3. Explore the protective effects of BaidiZiyin Pill and ShenqiYifei Pill on adverse reactions caused by chemotherapy.

Timeline

Start
2023-05-29
Primary completion
2026-10-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject BaiDiZiYin Pill Traditional medicine (herbal / TCM) 45 unknown
Subject ShenQiYiFei Pill Traditional medicine (herbal / TCM) 45 unknown
Background Ethambutol Small molecule 0.75 g
Background Ethambutol Small molecule 1 g
Background Isoniazid Small molecule 0.3 g
Background Pyrazinamide Small molecule 1.5 g
Background Rifampin Small molecule 0.45 g
Background Rifampin Small molecule 0.6 g