Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect
试验速览
- 阶段
- 1 期
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Gastroparesis Symptoms Rating Scale(GCSI)
研究概览
简要总结
With Diabetic gastroparesis as the research object, by the method of multi-center RCT and single cavity and different acupuncture acupoints compatibility treatment of diabetic gastroparesis, the inspection of gastric emptying, gastric dynamic inspection, such as validity checking means, for single cavity with different acupoints compatibility evaluate clinical efficacy of treatment of diabetic gastroparesis.
详细描述
In order to establish a spectrum of acupoints compatibility of the law, is clear about the factors affecting the compatibility effect of acupoints, the formation of strong operability of acupoints compatibility optimization evaluation method, the project choice of the clinical acupuncture and moxibustion have curative effect of diabetic gastroparesis as the breakthrough point of the study, carried out clinical multi-center RCT research, through objective and scientific evaluation method, comparing the effect of different acupoints compatibility.
Diabetic gastroparesis in clinical common disease, frequently-occurring disease, acupuncture curative effect is distinct, disease diagnosis, curative effect evaluation standard. Previous clinical data also show that the diabetic gastroparesis is acupuncture clinical diseases. This project by diabetic gastroparesis as the research object, research to better guide clinical practice, improve the clinical curative effect, promote acupuncture of the inheritance and innovation, promote scientification of acupuncture and moxibustion, modernization and internationalization, and will have broad prospect of application and significant scientific research value.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Diabetic Gastroparesis;
- •Aged 18-60 (including 18 and 60);
- •Fasting venous blood sugar ≤7.8mmol/L,2-hour post-meal blood glucose ≤ 13.6mmol/ L;
- •Diabetes more than 3 years;
- •Diet and exercise therapy or diet movement and exercise therapy based on the use of hypoglycemic drugs (except alpha glycosidase inhibitor) treatment, dose stable at least more than 3 months;
- •Rounding out the top three months did not participate in any clinical subjects;
- •Sign the informed consent and voluntary to participate in the study.
排除标准
- •Patients with reflux esophagitis;
- •Postoperative gastroparesis patients;
- •Ketoacidosis, non ketosis acute complications such as hypertonic coma;
- •Patients with acute cardiovascular disease, with severe trauma or surgery, severe infections, pregnancy or breast-feeding women;
- •Patients with myocardial infa,acute coronary syndrome (ACS),coronary revascularization;
- •Patients with severe liver disease, or the AST and/or ALT 2 times higher than normal ceiling;
- •Patients with Serum creatinine kidney damage, more than 140 umol/L;
- •Patients with obvious blood system diseases (either in person are not to be included in the item: Hb: men < 110 g/L, women < 100 g/L, the WBC < 3.5×109/L/L, PLT < 80×109/L);
- •Patients's systolic pressure≥180mmHg,Patients's diastolic pressure≥100mmHg;
- •Patients with Advanced malignant tumor or other serious wasting disease, infection and bleeding;
- •Endoscopy has the organic lesion such as peptic ulcer;
- •Disorders or do not fit the person and the growing experiment condition or severe complications;
- •Nearly four weeks of alpha glycosidase inhibitor drugs.
结局指标
主要结局
Gastroparesis Symptoms Rating Scale(GCSI)
时间窗: 8 weeks
次要结局
- FBG(fasting blood-glucose)(8 weeks)
- PPG(postprandial blood sugar)(8 weeks)
- Gastric emptying check by Color ultrasonography(8 weeks)
- Gastric emptying check by X rays(8 weeks)
- Short form 36 health survey(SF-36)(8 weeks)
- Self-rating anxiety scale(SAS)(1 week)
- Self-Rating Depression Scale(SDS)(1 week)
研究者
Tie Li
973 project management deputy director of the office
Changchun University of Chinese Medicine