drugset / Trial / NCT04324138

Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease

NCT04324138

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2020-07-15
Primary completion
2021-12-01
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Jianpi Qinghua granules Traditional medicine (herbal / TCM)