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

Diabetic Gastroparesis Clinical Trial

Official title:

Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02452489
• Other study ID #: ChangchunUCM02
• Status: Recruiting
• Phase: Phase 1
• First received: May 20, 2015
• Last updated: May 21, 2015
• Start date: January 2015
• Est. completion date: August 2018

Study information

• Verified date: May 2015
• Source: Changchun University of Chinese Medicine
• Contact: Tie Li, Ph.D
• Phone: +86 0431 86714973
• Email: zusanli_1999[@]126.com
• Is FDA regulated: No
• Health authority: National Health and Family Planning Commision of the People's Republic of China,People's Republic of China:
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: August 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

Intervention

Device:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	The Affiliated Hospital To Changchun University of Chinese Medicine	Changchun	Jilin

Sponsors (6)

Lead Sponsor	Collaborator
Changchun University of Chinese Medicine	Hengyang Traditional Chinese Medicine Hospital, Jilin University, Qilu Hospital, Second People's Hospital of Hunan, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastroparesis Symptoms Rating Scale(GCSI)		8 weeks	No
Secondary	FBG(fasting blood-glucose)		8 weeks	No
Secondary	PPG(postprandial blood sugar)		8 weeks	No
Secondary	Gastric emptying check by Color ultrasonography		8 weeks	No
Secondary	Gastric emptying check by X rays		8 weeks	No
Secondary	Short form 36 health survey(SF-36)		8 weeks	No
Secondary	Self-rating anxiety scale(SAS)		1 week	No
Secondary	Self-Rating Depression Scale(SDS)		1 week	No