Efficacy and Safety of Chinese Medicine in the Treatment of Patients with Pulmonary Nodules-A Multicenter Open Label Randomized Controlled Study: A Study Protocol for a Randomized Controlled Trial

Abstract

As the popularity of early screening of tumors, more and more people have detected pulmonary nodules, of which about 3.48% was lung cancer. However, false positive rates accounted for 1.4-23.3% according to trials reported. Therefore, pulmonary nodules may be over treated. In the clinical practice, we found that traditional Chinese medicine treatment makes some patients’ lung nodules shrink or even disappear but this effect needs to be approved. Therefore, we design this global network randomized controlled study (RCT) study to explore the efficacy and safety of traditional Chinese medicine in the treatment of pulmonary nodules. This study is a multicenter, open, prospective, randomized, controlled study. In this study, participants will be randomly assigned to traditional Chinese medicine or routine treatment observation group. About 166 patients with pulmonary nodules will be registered within 12 months and followed up for at least 2 years. The important feature of this clinical trial is to provide services to patients with pulmonary nodules worldwide by combining online and offline diagnosis and treatment, excluding interference factors such as region, climate, environment, eating habits etc. At the same time, it also will save costs and improves patient compliance. This trial design will also conduct subgroup analysis on the population of traditional Chinese medicine in the treatment of pulmonary nodules and establish a mathematical model to analyze the dominant population of traditional Chinese medicine in pulmonary nodules and the predictive factors of curative effect.