Chinese Medicine JQ Granule Combined with Half-dose Omeprazole for Nonerosive Reflux Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial Study Protocol

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 analysisThis 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.DiscussionThis study will focus on the quality control of a Chinese medical formulation, and 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.
Source: European Journal of Integrative Medicine - Category: Complementary Medicine Source Type: research