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
المؤلفون المشاركون
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
المصدر
Evidence-Based Complementary and Alternative Medicine
العدد
المجلد 2018، العدد 2018 (31 ديسمبر/كانون الأول 2018)، ص ص. 1-8، 8ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2018-12-02
دولة النشر
مصر
عدد الصفحات
8
التخصصات الرئيسية
الملخص 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).
نمط استشهاد جمعية علماء النفس الأمريكية (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
نمط استشهاد الجمعية الأمريكية للغات الحديثة (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
نمط استشهاد الجمعية الطبية الأمريكية (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
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1154513
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر