This study focuses on patients with NERD (gastroesophageal reflux disease) and liver-gallbladder disharmony syndrome as its research subjects. It conducts a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the Chai Zhi He Wei formula in terms of symptom improvement, quality of life, and adverse reactions. On one hand, this research aims to enhance the level of evidence-based medicine for TCM syndrome differentiation and treatment of NERD. On the other hand, it seeks to reduce the dosage of PPIs (proton pump inhibitors) or discontinue their use, addressing the side effects caused by PPI overuse, and serving as a leading example for TCM clinical research. Lastly, the study aims to optimize the efficacy of Tongjiang granules and address potential safety concerns, such as diarrhea.
Meet thediagnosis criteria for NERD;
GERD Q scale score >8 points;
Meet the criteria for the liver-stomach disharmony syndrome in traditional Chinese medicine;
Age between 18-70 years old;
Patients with active gastric or duodenal ulcers, gastritis with active bleeding, severe dysplasia of the gastric mucosa, or suspected malignancy; patients with achalasia or post-achalasia surgery; and patients with functional heartburn.
Patients with severe primary diseases of the cardiovascular, hepatic, renal, hematological, or respiratory systems, or malignant tumors.
Patients with mental disorders (e.g., schizophrenia, bipolar affective disorder, depression, anxiety, obsessive-compulsive disorder) and those with intellectual or language impairments.
Pregnant or breastfeeding women.