Different Acupoints Compatibility Difference of the Effect of Treatment of the Diabetic Gastroparesis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect

Conditions
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Diabetic Gastroparesis

Intervention / Treatment
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* Device: acupuncture
* Device: acupuncture
* Device: acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single point group (Zhongwan)<br>Patients will be acupuncture with Zhongwan(RN12). | Device: acupuncture<br>* 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.<br>|
| Other: Combination of He-Mu points group<br>Patients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12). | Device: acupuncture<br>* Patients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and 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.<br>|
| Other: Control group<br>Patients in Control group,will be acupuncture with at the junction of deltoid and biceps. | Device: acupuncture<br>* Patients in Control group,will be acupuncture with at the junction of deltoid and biceps,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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastroparesis Symptoms Rating Scale(GCSI) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Different acupoints compatibility