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

Feng Yun Wang, Lidan ZHONG, Nan Kang, Liang Dai, Lin Lv, Li Qun Bian, Ting Chen, Bei Hua Zhang, Zhaoxiang BIAN, Xiao Ge Wang, En Lin Zhu, Xu Dong Tang*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)688-694
Number of pages7
JournalEuropean Journal of Integrative Medicine
Volume8
Issue number5
DOIs
Publication statusPublished - 1 Oct 2016

Scopus Subject Areas

  • Complementary and alternative medicine

User-Defined Keywords

  • Functional dyspepsia
  • JianPi'I
  • Postprandial distress syndrome
  • Randomized controlled trial
  • Traditional Chinese medicine

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