Chinese herbal formula for postprandial distress syndrome: Study protocol of a double-blinded, randomized, placebo-controlled trial

Introduction: Functional dyspepsia is one of the typical functional gastrointestinal disorders and can be further categorized into postprandial distress syndrome and epigastric pain syndrome. The clinical response to conventional medicine treatment is unsatisfactory so that a majority of the population will seek help from Traditional Chinese Medicine. In clinical practice JianPi'I, derived from a classical TCM formula Xiangshaliujunzi decoction, appears to have a satisfactory effect on functional dyspepsia. Therefore, in order to further verify the benefit of JianPi'I, we designed a strict clinical trial to evaluate the safety and efficacy of JianPi'I in postprandial distress syndrome patients. Methods: This is a 10-week, multicenter, randomized, double-blinded, placebo-controlled trial. Eligible 144 patients will randomly be assigned to JianPi'I or placebo. The primary outcome is the change in the postprandial discomfort severity scale from baseline to treatment endpoint. The secondary outcomes include the changes in the clinical global impression scale, Traditional Chinese Medicine symptoms scores, MOS 36-Item Short-Form Health Survey and gastric emptying from baseline to treatment endpoint. Discussion: The main ingredients of JianPi'I contain Radix Codonopsis (Dangshen), Rhizoma Atractylodis Macrocephalae (Baizhu), Poria (Fuling), Fructus Amomi (Sharen), Radix Glycyrrhizae (Gancao), Radix Aucklandiae (Muxiang), Pericarpium Citri Reticulatae (Chenpi), and Rhizoma Pinelliae (Banxia), which are expected to alleviate symptoms of postprandial distress syndrome. This randomized placebo-controlled trial will comprehensively examine the efficacy and safety of JianPi'I in postprandial distress syndrome patients, and aim to provide a new treatment option for clinical practice in postprandial distress syndrome management. (C) 2016 Published by Elsevier GmbH.