Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial
ADG-RCT
1 other identifier
interventional
210
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether the different combination of acupoints have different effect on diabetic gastroparalysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedNovember 3, 2015
September 1, 2015
1 year
October 31, 2015
October 31, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
the score of GCSI
GCSI means gastroparesis cardinal symptom index
4 weeks
Secondary Outcomes (3)
Gastric emptying time
4 weeks
gastrin concentrations
4 weeks
motilin concentrations
4 weeks
Study Arms (3)
acupoints combination 1
EXPERIMENTALacupoints comination 1 includes the specific acupoint ST36 (Zusanli) and a local acupoint CV12 (Zhongwan).
acupoints combination 2
ACTIVE COMPARATORacupoints comination 2 includes the specific acupoint ST36 (Zusanli) and a distal acupoint PC6(Neiguan).
sham acupoints combination
SHAM COMPARATORsham acupoints combination includes the specific acupoint ST36 (Zusanli) and a sham acupoint.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32399130DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zenghui Yue, Prof.
Hunan University of Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2015
First Posted
November 3, 2015
Study Start
December 1, 2015
Primary Completion
December 1, 2016
Last Updated
November 3, 2015
Record last verified: 2015-09