MITE (Compound Azintamide Enteric-coated Tablets) in the Treatment of Dyspepsia After Cholecystectomy: a Multicenter, Randomized, Superior, Parallel Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 入组人数
- 990
- 主要终点
- Symptom assessment
研究概览
简要总结
To confirm the clinical efficacy of Compound Azintamide Enteric-coated Tablets in the treatment of patients with dyspepsia after cholecystectomy (such as abdominal distension, abdominal pain/abdominal discomfort, diarrhea/fatty stool, early satiety, belching, loss of appetite, etc.) by comparing with positive control drug, to observe its safety, and to evaluate the quality of life of subjects before and after treatment
详细描述
This study is a multi-center, randomized, superiority and parallel controlled clinical study. Third-party institutions will generate random codes according to random numbers of the software and divide them into two groups (Compound Azintamide Enteric-coated Tablets Group, Oryz-aspergillus Enzyme and Pancreatin Tablet and Ursodeoxycholic Acid Tablets Group) in a ratio of 1:1. Random numbers will be sealed and stored in radiopaque envelopes, which will be managed by a designated person not involved in the specific study.
Specific intervention measures: If dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, the experimental group takes Compound Azintamide Enteric-coated Tablets, and the control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit
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
- None
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
- •Aged 18-70 years old, male or female;
- •Patients after laparoscopic cholecystectomy, mainly including cholecystectomy due to cholecystitis, gallstones, gallbladder polyps and other benign gallbladder tumors, non-functioning gallbladder;
- •Dyspeptic symptoms occurred 2 weeks after laparoscopic cholecystectomy, including: abdominal distension, abdominal pain/abdominal discomfort, diarrhea/fatty stool, early satiety, belching, loss of appetite;
- •Signed informed consent, agreed to participate in this study.
排除标准
- •Patients with abnormal liver function and renal function;
- •Patients with severe heart and lung dysfunction;
- •Patients with neurological, mental illness or other reasons can not cooperate with the study;
- •Patients with advanced malignant tumors or other serious wasting diseases, any unstable chronic diseases and acute diseases, interfere with the efficacy evaluation of this study (such as patients undergoing chemotherapy) and the completion of the trial plan;
- •Patients with biliary obstruction, acute hepatitis, etc., do not use the test drugs and control drugs, and allergic to the test drugs and control drugs;
- •Patients who have taken digestive enzymes and cholagogue drugs by themselves;
- •Pregnant and lactating women;
- •Patients who are participating in other clinical trials;
- •Patients who cannot be followed up on time.
- •Elimination Criteria
- •Failure to take medicine as required, that is,Failure to take medicine or missed doses ≥ 3 times within 1week;
- •Taking other digestive enzymes, cholagogues and prokinetic drugs or drugs affecting digestive enzymes and bile secretion and excretion during the study;
- •Adverse events occur, for the benefit of patients, doctors believe that the drug should not be continued; the results of such cases do not participate in the efficacy statistics, but are related to the safety evaluation.
- •Drop-out Criteria
- •Cases with adverse events and patients are not willing to continue participating in the study.
- •Cases who voluntarily withdrew consent from the study due to poor efficacy and inconvenience in follow-up.
- •cases lost to follow-up due to various reasons.
研究组 & 干预措施
Compound Azintamide Enteric-coated Tablets
If dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, the experimental group takes Compound Azintamide Enteric-coated Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit.
干预措施: Compound Azintamide Enteric-coated Tablets (Drug)
Oryz-aspergillus Enzyme
If dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, the control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit.
干预措施: Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets (Drug)
结局指标
主要结局
Symptom assessment
时间窗: 28days
scored according to the severity of symptoms. severity: 0 : asymptomatic. 1. : The patient can recall symptoms only after being reminded. 2. : There are symptoms, but it does not affect daily life. 3 points: Symptoms are present, affecting daily life.
Efficacy evaluation
时间窗: 28days
symptom score improvement rate = (symptom score before treatment - symptom score after treatment)/symptom score before treatment × 100%. Significantly effective: symptom score improvement rate \> 75%. Effective: symptom score improvement rate 50% \~ 75% (including 50%). Improvement: symptom score improvement rate of 25% \~ 50% (including 25%). Ineffective: symptom score improvement rate \< 25%. Worsening: The symptom score increased after medication. Overall response rate = (number of effective cases + number of significantly effective cases)/total number of cases × 100%.
次要结局
- The incidence of adverse events (AE)(28days)
- Quality of life assessment(28days)
- Pharmacoeconomic evaluation(28days)