Diabetic Gastroparesis
Conditions
Keywords
Different acupoints compatibility
Brief summary
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.
Detailed description
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.
Interventions
DEVICEacupuncture
Patients will be acupuncture with Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks.
Sponsors
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Hengyang Traditional Chinese Medicine Hospital
Second People's Hospital of Hunan
Jilin University
Qilu Hospital of Shandong University
Changchun University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastroparesis Symptoms Rating Scale(GCSI) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| PPG(postprandial blood sugar) | 8 weeks |
| Gastric emptying check by Color ultrasonography | 8 weeks |
| Gastric emptying check by X rays | 8 weeks |
| FBG(fasting blood-glucose) | 8 weeks |
| Self-rating anxiety scale(SAS) | 1 week |
| Self-Rating Depression Scale(SDS) | 1 week |
| Short form 36 health survey(SF-36) | 8 weeks |
Countries
China
Contacts
Primary ContactTie Li, Ph.D
Outcome results
None listed