Chinese medicine JQ granule combined with half-dose omeprazole for nonerosive reflux disease: A multicenter, randomized, double-blind, placebo-controlled trial study protocol

Abstract

Abstract 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\u2009mg omeprazole plus 10\u2009mg dummy omeprazole; and dummy herb granules plus 20\u2009mg 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.