Chinese medicine JQ granule combined with half-dose omeprazole for nonerosive reflux disease: A multicenter, randomized, double-blind, placebo-controlled trial study protocol
机构:[1]Graduate School, Beijing University of Chinese Medicine, No. 11, Beisanhuandong Road, Chaoyang District, Beijing 100029, PR China[2]Department of Gastroenterology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Xiyuan Road, Haidian District, Beijing 100091, PR China[3]The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, 55 Neihuan Xilu, Xiaoguwei Street, Panyu District, Guangzhou Higher Education Mega Center, Guangzhou 510006, PR China广东省中医院
Introduction: Nonerosive reflux disease (NERD) is a kind of esophageal disease manifesting mainly as heartburn and regurgitation. The prevalence of NERD in patients with gastroesophageal reflux disease is up to 70%, and it significantly affects the quality of life of patients. In China, besides proton-pump inhibitors (PPIs), a herbal formula is widely used in nonerosive reflux disease, which can improve intestinal and extra-intestinal symptoms of patients. This study will evaluate in a large, independent, randomized controlled trial (RCT) the comparative effectiveness of a specific type of Chinese herbal granule with half-dose PPI and full-dose PPI in managing nonerosive reflux disease. Methods and analysis: This trial will be a multicenter, randomized, double-blind, placebo-controlled RCT. A total of 204 participants will be enrolled and randomized (1:1) to each group: herb granules plus 10 mg omeprazole plus 10 mg dummy omeprazole; and dummy herb granules plus 20 mg omeprazole. The efficacy measures will be the changes in scores in the Gastroesophageal Reflux Disease Questionnaire, the Short-Form 36, the Patient Report Outcome, the 17-item Hamilton Depression Scale, and the Signs and Symptoms Scale. Discussion: This study will focus on the quality control of a Chinese medical formulation. The RCT research procedure will be conducted under the supervision of the Good Clinical Practice (GCP) center. This trial will reduce the routine dosage of omeprazole while adding Jianpi Qinghua JQ granule, with the aim to discuss the safety and effectiveness of the Chinese herbal granule on esophageal and extraesophageal symptoms while meeting the ethical requirements.
基金:
Beijing Municipal Science and Technology Commission, Beijing, ChinaBeijing Municipal Science & Technology Commission [Z161100000116046]; Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China [02-104]
第一作者机构:[1]Graduate School, Beijing University of Chinese Medicine, No. 11, Beisanhuandong Road, Chaoyang District, Beijing 100029, PR China[2]Department of Gastroenterology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Xiyuan Road, Haidian District, Beijing 100091, PR China
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推荐引用方式(GB/T 7714):
Shi Xiaoshuang,Li Xia,Ma Jinxin,et al.Chinese medicine JQ granule combined with half-dose omeprazole for nonerosive reflux disease: A multicenter, randomized, double-blind, placebo-controlled trial study protocol[J].EUROPEAN JOURNAL OF INTEGRATIVE MEDICINE.2019,31:doi:10.1016/j.eujim.2019.100974.
APA:
Shi, Xiaoshuang,Li, Xia,Ma, Jinxin,Che, Hui,Ma, Xiangxue...&Wang, Fengyun.(2019).Chinese medicine JQ granule combined with half-dose omeprazole for nonerosive reflux disease: A multicenter, randomized, double-blind, placebo-controlled trial study protocol.EUROPEAN JOURNAL OF INTEGRATIVE MEDICINE,31,
MLA:
Shi, Xiaoshuang,et al."Chinese medicine JQ granule combined with half-dose omeprazole for nonerosive reflux disease: A multicenter, randomized, double-blind, placebo-controlled trial study protocol".EUROPEAN JOURNAL OF INTEGRATIVE MEDICINE 31.(2019)