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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Placebo (a simulator of), 1 packet per dose, twice daily, to be taken 1 hour after breakfast and dinner, with a course duration of 4 weeks. |
|
| Experimental Group | Active Comparator | Chaizhi Hewei Granules, 1 packet per dose, twice daily, take 1 hour after breakfast and dinner, course duration: 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chaizhi Hewei Decoction | Drug | Chaizhi Hewei Decoction Granules, 1 packet per dose, twice daily, take 1 hour after breakfast and dinner, course duration: 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastroesophageal Reflux Disease Questionnaire (GERD Q) Score | week 0 and the end of treatment at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Traditional Chinese Medicine (TCM) syndrome improvement status | week 0 and the end of treatment at 4 weeks | |
| SF-36 Scale Score | week 0 and the end of treatment at 4 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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.
Patients allergic to any components of this preparation.
Patients currently taking medications that may affect the outcome of this study (e.g., proton pump inhibitors, potassium-competitive acid blockers, Tongjiang granules, etc.).
Patients currently participating in or having participated in other drug clinical trials within the past 4 weeks.
Patients with suspected or confirmed history of alcohol or substance abuse, anxiety, or depression; or, according to the investigator's judgment, other conditions that may reduce the likelihood of enrollment or complicate the enrollment process, such as frequent changes in work environment that may lead to loss of follow-up.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lin lv, Doctor | Contact | 86-18811782728 | lushangshitou@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | Beijing | Beijing Municipality | 100091 | China |
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| Placebo | Drug | Placebo, 1 packet per dose, twice daily, to be taken 1 hour after breakfast and dinner, with a course duration of 4 weeks. |
|
| Patient-Reported Outcomes (PRO) Scale Scoring |
| week 0 and the end of treatment at 4 weeks |
| 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. | week 0 and the end of treatment at 4 weeks |
| week 0 and the end of treatment at 4 weeks |
| 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. | week 0 and the end of treatment at 4 weeks |
| ID | Term |
|---|---|
| D000096663 | Non-Erosive Reflux Disease |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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