Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial | NCT02594397 | Trialant
Unknown statusInterventionalNot ApplicableUpdated Nov 3, 2015
Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial
ClinicalTrials.gov ID
NCT02594397
Lead Sponsor
The First Affiliated Hospital of Hunan University of Traditional Chinese MedicineOTHER
Overall Status
Unknown status
Study Type
Interventional
Phase
Not Applicable
Enrollment
210Estimated
Last Update Posted
Nov 3, 2015Estimated
Start Date
Dec 2015
Primary Completion Date
Dec 2016Estimated
Brief Summary
The purpose of this study is to determine whether the different combination of acupoints have different effect on diabetic gastroparalysis.
Gastroparesis
Diabetes Complications
acupoints combination 1
acupoints combination 2
sham acupoints combination
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 α-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 α-glucosidase inhibitor drug in the past four weeks.
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Mailan Liu, Dr.Contact
445007305@qq.com86-731-88458187
Ping LiContact
472198992@qq.com
No locations
There are no locations for this study.
Lead Sponsor
The First Affiliated Hospital of Hunan University of Traditional Chinese MedicineOTHER