Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Nonerosive reflux disease (NERD) is a common refractory gastrointestinal disease. Proton pump
inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about
50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor;
long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal
dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical
syndrome of NERD.TCM syndrome differentiation and treatment has the advantages of overall
regulation and individualized treatment, but lack of high-level evidence. The purpose of this
study is to evaluate the efficacy and safety of Jianpi Qinghua Granules for treating NERD
with spleen deficiency and damp heat syndrome.
Phase:
Early Phase 1
Details
Lead Sponsor:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators:
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Liaoning University of Traditional Chinese Medicine