To evaluate the efficacy and safety of Changweishu Capsules in the treatment of epidermal growth factor receptor(EGFR)-tyrosine kinase inhibitor(TKI)-associated diarrhea in lung cancer patients.Methods:A multicenter prospective randomized controlled clinical trial was conducted，in which 103 non-small cell lung cancer patients with diarrhea caused by EGFR-TKI were randomized into an observationn group and a control group by the closed-envelope method at the ratio of 2:1.The patients in the observation and control groups were administrated with Changweishu Capsules and Xianglian Tablets，respectively，for 2 weeks.The safety and efficacy indicators were measured.Results:The traditional Chinese medicine(TCM) syndrome score showed significant differences between before and after treatment，and the observation group outperformed the control group(P=0.008).The clinical response showed no difference between the two groups(P=0.063).The symptom scores changed significantly after treatment(P<0.001).The differences of diarrhea(P=0.024) and anorexia(P=0.009) between before and after treatment varied between the two groups.In addition，the observation group outperformed the control group in mitigating diarrhea(P=0.019)，abdominal distension(P=0.034)，and anorexia(P=0.005).The observation group was superior to the control group in treating the grade 3 diarrhea(P=0.034).Conclusion:Changweishu Capsules demonstrated good efficacy with good patient compliance and no adverse reactions for EGFR-TKI-associated diarrhea symptoms in lung cancer patients，being worthy of clinical application and promotion.