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

Changchun University of Chinese Medicine

Status and phase: Unknown; Phase 1

Conditions: Diabetic Gastroparesis

Treatments: Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02452489

ChangchunUCM02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 3 patient groups

Single point group (Zhongwan)

Other group

Description:

Patients will be acupuncture with Zhongwan(RN12).

Treatment:

Device: acupuncture

Device: acupuncture

Device: acupuncture

Combination of He-Mu points group

Other group

Description:

Patients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12).

Treatment:

Device: acupuncture

Device: acupuncture

Device: acupuncture

Control group

Other group

Description:

Patients in Control group,will be acupuncture with at the junction of deltoid and biceps.

Treatment:

Device: acupuncture

Device: acupuncture

Device: acupuncture