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.
Parallel
Chaizhi Hewei Decoction
DrugChaizhi Hewei Decoction Granules, 1 packet per dose, twice daily, take 1 hour after breakfast and dinner, course duration: 4 weeks.
Placebo
DrugPlacebo, 1 packet per dose, twice daily, to be taken 1 hour after breakfast and dinner, with a course duration of 4 weeks.
Gastroesophageal Reflux Disease Questionnaire (GERD Q) Score
Traditional Chinese Medicine (TCM) syndrome improvement status
SF-36 Scale Score
Patient-Reported Outcomes (PRO) Scale Scoring
Hospital Anxiety and Depression Scale (HAD) score
Scale Title: Hospital Anxiety and Depression Scale (HAD) Minimum Score: 0 Maximum Score:21 (for each subscale: Anxiety \[A\] and Depression \[D\]) Interpretation: Higher scores indicate worse outcomes (greater anxiety or depressive symptoms), with 0-7 = no symptoms, 8-10 = possible symptoms, 11-21 = definite symptoms.
Hematuria Metabolomics
Outcome Measure Title: Changes in Plasma and Urine Metabolite Profiles Assessed by Untargeted Metabolomics Using Liquid Chromatography-Mass Spectrometry (LC-MS) Outcome Measure Description: Untargeted metabolomics analysis will be performed on plasma and urine samples collected from patients before and after treatment. The measurement tool is liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). The outcome measure is the relative abundance of detected metabolites. Unit of measure: Normalized peak intensity (arbitrary units) or relative ion count.
Fecal Gut Microbiota Metagenomics
Outcome Measure Title: Changes in Gut Microbial Composition and Functional Genes Assessed by Shotgun Metagenomic Sequencing of Fecal Samples Outcome Measure Description: Shotgun metagenomic sequencing will be performed on fecal samples collected before and after treatment. The measurement tool is high-throughput next-generation sequencing (e.g., Illumina platform). The outcome measures include taxonomic relative abundance of microbial species, gene richness, and functional pathway abundances. Unit of measure: Relative abundance (percentage of total reads) and reads per kilobase per million (RPKM) for gene quantification.
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