Clinical Efficacy Evaluation of Chaizhi Hewei Decoction in the Treatment of Non-Erosive Reflux Disease With Liver-Stomach Disharmony Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Gastroesophageal Reflux Disease Questionnaire (GERD Q) Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Participants are informed and voluntarily sign the informed consent form. -
排除标准
- •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.
研究组 & 干预措施
Control Group
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.
干预措施: Placebo (Drug)
Experimental Group
Chaizhi Hewei Granules, 1 packet per dose, twice daily, take 1 hour after breakfast and dinner, course duration: 4 weeks.
干预措施: Chaizhi Hewei Decoction (Drug)
结局指标
主要结局
Gastroesophageal Reflux Disease Questionnaire (GERD Q) Score
时间窗: week 0 and the end of treatment at 4 weeks
次要结局
- 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)
- Patient-Reported Outcomes (PRO) Scale Scoring(week 0 and the end of treatment at 4 weeks)
- Hospital Anxiety and Depression Scale (HAD) score(week 0 and the end of treatment at 4 weeks)