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Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial
Joint Authors
Sun, Xin
Zhang, Kun-He
Chen, Xiaofan
Nie, Heyun
Liu, Wenjun
Zhou, Xu
Nie, Jianhua
Xie, Bin
Chen, Dongping
Jiang, Yiping
Fu, Ying
Yang, Deping
Xiong, Yan
Zhao, Zhangyang
Zhu, Weifeng
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2018, Issue 2018 (31 Dec. 2018), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2018-12-02
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
Background.
There is a worldwide epidemic of nonorganic gastrointestinal disorders (NOGDs), which are a class of disorders that cause various discomforts and ultimately progress into organic gastrointestinal diseases.
Because of the unsatisfactory efficacy of Western medical treatments, traditional Chinese medicine (TCM) is becoming a promising complementary and alternative treatment to manage NOGDs.
Objectives.
To investigate the efficacy and safety of Hou Gu Mi Xi (HGMX), a newly developed dietary TCM formula, on the syndrome of spleen qi deficiency (SQD) in patients with NOGDs.
Methods/Design.
This study is a multicenter, randomized, double-blinded, parallel, and placebo-controlled trial that will last for 2 years.
All qualified subjects with NOGDs and SQD will be included.
The study population will be divided into the HGMX and placebo groups.
To assess the efficacy of HGMX, we will mainly focus on changes in SQD symptoms scored by a Spleen Qi Deficiency Symptoms Grading and Quantifying Scale and evaluate changes in gastrin-17, the negative Helicobacter pylori conversion rate, body weight, body mass index, and gastroscopy findings.
The safety of HGMX will be assessed by recording adverse events (AEs), severe AEs, treatment-related AEs and withdrawal due to AEs.
Discussion.
This trial is part of our study series that intends to validate the potential of HGMX in the management of chronic gastrointestinal diseases.
This series of RCTs is the first committed to the evaluation of a dietary TCM formula and will hopefully establish an evidence-based clinical research model for dietary TCM formulas.
Ethics.
The protocol was approved by Ethics Committee of five research hospitals and was registered in Clinicaltrials.gov (NCT03019042).
American Psychological Association (APA)
Chen, Xiaofan& Nie, Heyun& Liu, Wenjun& Zhou, Xu& Nie, Jianhua& Xie, Bin…[et al.]. 2018. Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial. Evidence-Based Complementary and Alternative Medicine،Vol. 2018, no. 2018, pp.1-8.
https://search.emarefa.net/detail/BIM-1154513
Modern Language Association (MLA)
Chen, Xiaofan…[et al.]. Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial. Evidence-Based Complementary and Alternative Medicine No. 2018 (2018), pp.1-8.
https://search.emarefa.net/detail/BIM-1154513
American Medical Association (AMA)
Chen, Xiaofan& Nie, Heyun& Liu, Wenjun& Zhou, Xu& Nie, Jianhua& Xie, Bin…[et al.]. Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial. Evidence-Based Complementary and Alternative Medicine. 2018. Vol. 2018, no. 2018, pp.1-8.
https://search.emarefa.net/detail/BIM-1154513
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1154513