A randomization and trial supply management system for adaptive clinical studies of TCM and its scientific research application in recurrent tuberculosis.

摘要

In recent years, a growing number of dynamic, double-blind and randomized trials for traditional Chinese medicine (TCM) have been designed with adaptive treatment regimens. The blind envelope or current randomization and trial supply management (RTSM) system have not met this requirement. Therefore, a more efficient platform for subject randomization and medicine dispensation was required. After we had done much research on dynamic TCM treatment trials' protocols, a new RTSM was designed and developed, which is suitable for TCM clinical trial during randomizing the groups for subject and medicine allocation in China. In a recurrent tuberculosis study of TCM, this RTSM system was involved in the management of subjects and medicines. By this system, a suit of TCM formulas or placeboes were assigned to patients based on their TCM syndrome diagnosis results by investigators at different visit points. The new RTSM system was convenient to operate, reduced operational errors, enhanced the management efficiency, and improved the data quality.