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Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial (ADG-RCT)

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The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Status

Unknown

Conditions

Diabetes Complications
Gastroparesis

Treatments

Other: acupoints combination 2
Other: acupoints combination 1
Other: sham acupoints combination

Study type

Interventional

Funder types

Other

Identifiers

NCT02594397
2014CB543102-2

Details and patient eligibility

About

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

Enrollment

210 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

210 participants in 3 patient groups

acupoints combination 1
Experimental group
Description:
acupoints comination 1 includes the specific acupoint ST36 (Zusanli) and a local acupoint CV12 (Zhongwan).
Treatment:
Other: acupoints combination 1
acupoints combination 2
Active Comparator group
Description:
acupoints comination 2 includes the specific acupoint ST36 (Zusanli) and a distal acupoint PC6(Neiguan).
Treatment:
Other: acupoints combination 2
sham acupoints combination
Sham Comparator group
Description:
sham acupoints combination includes the specific acupoint ST36 (Zusanli) and a sham acupoint.
Treatment:
Other: sham acupoints combination

Trial contacts and locations

0

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Central trial contact

Ping Li; Mailan Liu, Dr.

Data sourced from clinicaltrials.gov

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