Clinical trial NCT02452489: Different Acupoints Compatibility Difference of the Effect of Treatment of the Diabetic Gastroparesis
Official title: Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetic Gastroparesis
Keywords: Different acupoints compatibility
Lead sponsor: Changchun University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
name: Hengyang Traditional Chinese Medicine Hospital
name: Second People's Hospital of Hunan
name: Jilin University
name: Qilu Hospital of Shandong University
First posted: 2015-05-22
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gastroparesis Symptoms Rating Scale(GCSI)
timeFrame: 8 weeks
Secondary outcomes:
measure: FBG(fasting blood-glucose)
timeFrame: 8 weeks
measure: PPG(postprandial blood sugar)
timeFrame: 8 weeks
measure: Gastric emptying check by Color ultrasonography
timeFrame: 8 weeks
measure: Gastric emptying check by X rays
timeFrame: 8 weeks
measure: Short form 36 health survey(SF-36)
timeFrame: 8 weeks
measure: Self-rating anxiety scale(SAS)
timeFrame: 1 week
measure: Self-Rating Depression Scale(SDS)
timeFrame: 1 week
Other outcomes:
Locations:
city: Changchun
country: China
facility: The Affiliated Hospital To Changchun University of Chinese Medicine
state: Jilin
Study officials:
affiliation: Director
name: Fuchun Wang, master
role: STUDY_CHAIR
References: