Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial

Gastroparesis Clinical Trial

— ADG-RCT  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02594397
• Other study ID #: 2014CB543102-2
• Status: Not yet recruiting
• Phase: N/A
• First received: October 31, 2015
• Last updated: October 31, 2015
• Start date: December 2015

Study information

• Verified date: September 2015
• Source: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
• Contact: Mailan Liu, Dr.
• Phone: 86-731-88458187
• Email: 445007305[@]qq.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the different combination of acupoints have different effect on diabetic gastroparalysis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• individuals who meet the diagnostic criteria of diabetes gastric paralysis.

• individuals between the ages of 18 and 60 years.

• individuals who meet blood glucose control standards: Fasting plasma glucose (FPG) =7. 8mmol/L; 2 hours plasma glucose (2hPG)=13.6mmol/L.

• individuals who suffered for more than 3 years.

• individuals who treated with diet control or exercise or using hypoglycemic drug (except for a-glucosidase Inhibitor) on the basis of diet or exercise therapy and the dose stability must be last at least 3 months.

• individuals who receive no other treatments in the first 3 months.

• women who is at the age of childbearing age and take contraceptive measures.

• individuals who voluntarily agree with a study protocol and sign a written informed consent.

Exclusion Criteria:

• individuals who have reflux esophagitis;

• individuals who have gastroparesis after surgery;

• individuals who have acute complications with ketoacidosis and nonketotic hyperosmolar coma;

• individuals who have Acute cardiovascular and cerebrovascular diseases or Severe trauma or surgery, severe infection. Or who are pregnant or breastfeeding;

• individuals who have a history disease of myocardial infarction, acute coronary syndrome or coronary revascularization;

• individuals who have serious hepatobiliary disease, or AST and/or ALT 2 times greater than the upper limit of normal patients;

• individuals with kidney damage, and serum creatinine exceeds 140umol/L;

• individuals who have obvious blood system diseases (Any one of which can not be caught in line: Hb: male<110g/L, women<100g/L,WBC<3.5×109/L,PLT<80×109/L).

• individuals who have a problem of blood press:SBP=180mmHg,DPB=100mmHg;

• individuals who have cancer or other serious progressive wasting disease, and easy to infection and bleeding;

• individuals who have peptic ulcer or other organic disease confirmed by esophagogastroduodenoscopy;

• individuals unwilling to meet the testing and exacerbations,or have serious complications in the test;

• individuals who have taking a-glucosidase inhibitor drug in the past four weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Complications
• Gastroparesis

Intervention

Other:
• acupoints combination 1

• acupoints combination 2

• sham acupoints combination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the score of GCSI	GCSI means gastroparesis cardinal symptom index	4 weeks	Yes
Secondary	Gastric emptying time		4 weeks	Yes
Secondary	gastrin concentrations		4 weeks	Yes
Secondary	motilin concentrations		4 weeks	Yes