Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial
NCT ID: NCT02594397
Last Updated: 2015-11-03
Study Results
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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UNKNOWN
NA
210 participants
INTERVENTIONAL
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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acupoints combination 1
acupoints comination 1 includes the specific acupoint ST36 (Zusanli) and a local acupoint CV12 (Zhongwan).
acupoints combination 1
acupoints combination 2
acupoints comination 2 includes the specific acupoint ST36 (Zusanli) and a distal acupoint PC6(Neiguan).
acupoints combination 2
sham acupoints combination
sham acupoints combination includes the specific acupoint ST36 (Zusanli) and a sham acupoint.
sham acupoints combination
Interventions
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acupoints combination 1
acupoints combination 2
sham acupoints combination
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
60 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Zenghui Yue, Prof.
Role: STUDY_CHAIR
Hunan University of Chinese Medicine
Central Contacts
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References
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Xuefen W, Ping L, Li L, Xiaoli C, Yue Z. A Clinical Randomized Controlled Trial of Acupuncture Treatment of Gastroparesis Using Different Acupoints. Pain Res Manag. 2020 Apr 25;2020:8751958. doi: 10.1155/2020/8751958. eCollection 2020.
Other Identifiers
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2014CB543102-2
Identifier Type: -
Identifier Source: org_study_id
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