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Trials
Published in: Trials 1/2021

Open Access 01-12-2021 | Study protocol

Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial

Authors: Sai Ho Sin, Jing Wu, Yuchen Kang, Kar Hung Kevin Yip, Ngo Suet Kong, Hei Wan, Bacon Fung Leung Ng, Haiyong Chen

Published in: Trials | Issue 1/2021

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Abstract

Background

Postprandial distress syndrome manifests as a feeling of fullness and early satiation that can significantly reduce the quality of life of the patients. In Chinese medicine (CM), the syndrome is traditionally regarded as the Wei-Pi syndrome, and Banxia Xiexin decoction (BXD) has been used in the empirical treatment of the same for a long time. The current study aims to evaluate the efficacy of modified BXD in the management of Wei-Pi syndrome.

Methods/design

A randomized, waitlist-controlled trial will be conducted. A total of 84 patients with Wei-Pi syndrome will be randomized into the BXD or waitlist control group in a ratio of 1:1. The patients in the BXD group will receive the semi-individualized BXD on the basis of the syndrome differentiation in CM, for a duration of 3 weeks and will be under follow-up for further 3 weeks after the completion of therapy. Conversely, the patients in the waitlist control group will undergo the same intervention and follow-up after a 3-week waiting period. In the current study, the primary outcome will be the variation in the scores pertaining to the global scale of the Quality of Life Questionnaire for Functional Digestive Disorders after 3 weeks. The secondary outcomes include the variations in the scores pertaining to the Hospital Anxiety and Depression Scale and the EuroQoL 5-dimension 5-level Questionnaire and the results of the liver and kidney function tests.

Discussion

This trial will assess the efficacy of modified BXD in improving the clinical symptoms and quality of life of the patients suffering from Wei-Pi syndrome.

Trial registration

ClinicalTrials.​govNCT04398888. Registered on May 21, 2020
Appendix
Available only for authorised users
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Metadata
Title
Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial
Authors
Sai Ho Sin
Jing Wu
Yuchen Kang
Kar Hung Kevin Yip
Ngo Suet Kong
Hei Wan
Bacon Fung Leung Ng
Haiyong Chen
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Trials / Issue 1/2021
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-021-05078-y

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