中医药治疗胃癌合并高凝状态的临床试验方案设计特色与评价

Objective:To introduce the clinical trial protocol for Traditional Chinese Medicine therapy in gastric cancer complicated with hypercoagulable state and to evaluate the design features of this protocol.Methods:The advanced gastric cancer patients with hypercoagulable state are taken as the object of research in this multicenter, prospective, pragmatic randomized controlled trial conducted in accordance with the guidelines of Good Clinical Practice (GCP). To objectively evaluate the efficacy of Traditional Chinese Medicine therapy in gastric cancer complicated with hypercoagulable state and to explore the clinical mechanism of the treatment of gastric cancer complicated with hypercoagulable state according to the YiQiHuoXue ( tonify Qi and activate blood circulation) theory through the analysis of related indicator.Results:To determine the clinical efficacy and effect mechanism of Traditional Chinese Medicine therapy in gastric cancer complicated with hypercoagulable state by integrating the application of "QiXuXueYu"(Deficiency of Qi and blood stasis) Chinese Medicine theory and the related indicators of modern laboratory.Conclusion:This clinical trial protocol for Traditional Chinese Medicine therapy in gastric cancer complicated with hypercoagulable state is scientific and clinical applicable by integrating clinical presentation and objective laboratory indicators under the guidance of Chinese Medicine theory and it lays a foundation for future clinical application and professional acknowledgement.