Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial
| Autor: | Kar Hung Kevin Yip, Ngo Suet Kong, Hai-Yong Chen, Sai Ho Sin, Bacon F.L. Ng, Hei Wan, Jing Wu, Yuchen Kang |
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| Rok vydání: | 2021 |
| Předmět: |
Quality of life
Functional dyspepsia medicine.medical_specialty Medicine (miscellaneous) Traditional Chinese medicine Hospital Anxiety and Depression Scale law.invention Study Protocol 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Xiexin decoction law Internal medicine Humans Medicine Pharmacology (medical) Dyspepsia Wei-Pi syndrome Randomized Controlled Trials as Topic Postprandial distress syndrome lcsh:R5-920 Chinese medicine business.industry Liver and kidney Banxia Xiexin decoction Syndrome Distress Treatment Outcome Postprandial 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology lcsh:Medicine (General) business Drugs Chinese Herbal |
| Zdroj: | Trials, Vol 22, Iss 1, Pp 1-8 (2021) Trials |
| ISSN: | 1745-6215 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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