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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-08-31

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.

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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.

Conditions

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Diabetic Gastroparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Single point group (Zhongwan)

Patients will be acupuncture with Zhongwan(RN12).

Group Type OTHER

acupuncture

Intervention Type DEVICE

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.

Combination of He-Mu points group

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

Group Type OTHER

acupuncture

Intervention Type DEVICE

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.

Control group

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

Group Type OTHER

acupuncture

Intervention Type DEVICE

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.

Interventions

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acupuncture

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.

Intervention Type DEVICE

acupuncture

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.

Intervention Type DEVICE

acupuncture

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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No