drugset / Trial / NCT04340297

Summary

Nonerosive Reflux Disease (NERD) is a common refractory gastrointestinal disease. Proton Pump Inhibitors (PPIs), the preferred drug, have poor response, single target and poor acid inhibition effect in some patients in clinical application. Long-term use of PPI can lead to many side effects, even dependency. The main Traditional Chinese Medicine (TCM)syndrome types of NERD are liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome. TCM syndrome differentiation treatment has the advantages of overall regulation and individualized treatment. The purpose of this study is to evaluate the safety and efficacy advantages of syndrome differentiation series prescription combined with PPIs descending ladder withdrawal in the treatment of patients who use PPIs for a long time that can not stop, and to solve the problems of multiple side effects and dependency caused by long-term use of PPIs.

Timeline

Start
2020-06-15
Primary completion
2021-12-01
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Jianpi Qinghua granules Traditional medicine (herbal / TCM) Oral
Subject Tongjiang granules Traditional medicine (herbal / TCM) Oral
Subject Wenpi Qingwei granules Unknown Oral
Background Famotidine Other / unclassified 20 mg