Effective Mechanisms of Wu-Chu-Yu Tang on Gastroesophageal Disorder
试验速览
- 阶段
- 4 期
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- 24 hours esophageal PH
研究概览
简要总结
Gastroesophageal reflux disorder (GERD) is due to gastric content reflux to esophagus cause symptom and complication including intra-esophagus such as reflux esophagitis, and extra-esophagus such as cough etc. Because the changes of dietary habit, and improvement of examination skill and data analysis, the prevalence of GERD increased 2.5 multiple from 1995 to 2002, and suggesting the prevalence is 25% in Taiwan community.
The etiology of GERD is multi-effect, such as transient lower esophageal sphincter relaxation and abnormal pressure of lower esophageal sphincter, which may induced the esophageal mucosal injury by gastric acid, bile or pancreases enzyme.
Wu-Chu-Yu tang consists of Evodia fargesii Dode (Evodia Fruit), Panax ginseng C. (Ginseng), Ziziphus jujube Mill (Chinses Date), Zingiber officinale Rosee (Fresh Ginger).According to "I-Fang-Chi-Chieh" and "Shanghonzobinglun" recordings that Wu-Chu-Yu tang can treat vomiting, and also can relax gastric tonicity and can enhance peristalsis of stomach. According to Randomized, double blind, placebo control trial to evaluate the efficacy of Wu-Chu-Yu Tang on gastroesophageal reflux disease, we know the Wu-Chu-Yu tang have the equivalent effect proton pump inhibitor omeprazole. But, the mechanism of Wu-Chu-Yu tang is still unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender：male or female.
- •Age：from 20 years old (inclusive) to 75 years old (inclusive).
- •Diagnosis of gastroesophageal reflux disease.
- •there is a heartburn or acid regurgitation phenomenon.
- •After detailed description of the entire research purpose or process, voluntarily participate in the study and sign the consent form.
排除标准
- •Exclude peptic ulcers, gallstones (including intrahepatic and common bile ducts) and major diseases such as: cancer, congestive hear failured NYHA class>II, COPD attack.
- •Barrett's esophagus, narrow esophagus or caustic injury of upper gastrointestinal tract.
- •History of esophagus and gastroduodenal surgery.
- •Tarry stool suspected gastrointestinal bleeding.
- •History of alcohol or drug abuse.
- •Patients with a history of allergies to the test drug.
- •Can not cooperate with mental illness.
- •Pregnant women or women who are breastfeeding.
- •Liver function SGOT and SGPT are more than twice the normal value.
- •renal function test BUN, Creatinine is greater than the normal value.
研究组 & 干预措施
Wu-Chu-Yu tang
干预措施: Wu-Chu-Yu tang (Drug)
结局指标
主要结局
24 hours esophageal PH
时间窗: 28 days
Analysis the 24 hours PH change
DeMeester score
时间窗: 28 days
DeMeester score had two major component as 1.total time of pH\<4(%) and 2.number of reflux episode. Each major part had two minor component.Fist one, percentage of total time pH\<4, had 1. percentage of upright time when pH\<4 and 2.percentage of supine time when pH\<4. Secondary part, number of reflux episode, had 1.number of reflux episode over 5 mintues and 2.longest reflux time. Finally, there was a composite score as the DeMeester score.
次要结局
- Reflux Disease Questionnaire(56 days)
- SF-36 questionnaire(56 days)