Clinical Study on the Efficacy of Modified Liujunzi Prescription on the Treatment of Atrophic Gastritis After HP Eradication
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Therapeutic effectiveness of gastric mucosal lesions
研究概览
简要总结
This is an observational cohort study of clinical efficacy study.The purpose of this topic is to evaluate the efficacy and safety of Modified Liujunzi Decoction based on syndrome differentiation in patients with chronic atrophic gastritis(CAG) after HP eradication.Taking Modified Liujunzi Decoction as the observation group and Weifuchun routine treatment as the control group, so as to provide evidence for the treatment of CAG and reduce the risk of gastric cancer. A total of 284 patients were included. The curative efficacy, symptom score and adverse events will be recorded and analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients with CAG diagnosed by endoscopy and pathological examination, the pathological diagnosis criteria refer to the China consensus of chronic gastritis (2017) ;
- •Previous HP infection, HP negative after standardized treatment;
- •TCM syndrome differentiation mainly focuses on the weakness of the spleen and stomach,referring to the consensus on the diagnosis and treatment of chronic atrophic gastritis with integrated traditional Chinese and Western Medicine (2017), there is no restriction on concurrent syndrome;
- •Age 18-70 years old, regardless of gender;
- •The subject (or legal representative) voluntarily agreed and signed the informed consent form, and was able to abide by the study protocol during the study.
排除标准
- •History of gastric surgery;
- •Combined with serious diseases affecting the study evaluation, such as serious liver disease, heart disease, kidney disease, malignant tumor and alcoholism;
- •Allergic to the drugs used in this study;
- •Participated in clinical research of other drugs in the first 3 months of the study;
- •Patients can't express correctly their subjective feelings and can't cooperate.
研究组 & 干预措施
MLD
Modified Liujunzi Decoction,1 package twice daily,6 months
干预措施: MLD (Drug)
WFC
Weifuchun,three times a day, four at a time,6months
干预措施: WFC (Drug)
结局指标
主要结局
Therapeutic effectiveness of gastric mucosal lesions
时间窗: Half a year,a year
Referring to the CAG of the "Guidelines for Clinical Research on New Chinese Medicines (2002)", the effective treatment of gastric mucosal lesions is defined as "the pathological score decreased by 1 point compared with the previous point". The effective rate of gastric mucosal lesions treatment = the number of cases with a decrease of ≥ 1 point by the previous score / the total number of cases × 100%. The effective rate of gastric mucosal lesions from different category will be calculated: respectively for atrophy, chronic inflammation, activity, intestinal metaplasia, and intraepithelial neoplasia .
次要结局
- The recurrence of HP(Half a year,a year)
- Changes in clinical symptom scores(The third month,half a year ,the ninth month,a year.)
- The efficacy of OLGA,OLGIM(Half a year,a year)