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.
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.
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