- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02594397
Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial (ADG-RCT)
October 31, 2015 updated by: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
The purpose of this study is to determine whether the different combination of acupoints have different effect on diabetic gastroparalysis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
210
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mailan Liu, Dr.
- Phone Number: 86-731-88458187
- Email: 445007305@qq.com
Study Contact Backup
- Name: Ping Li
- Email: 472198992@qq.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: acupoints combination 1
acupoints comination 1 includes the specific acupoint ST36 (Zusanli) and a local acupoint CV12 (Zhongwan).
|
|
ACTIVE_COMPARATOR: acupoints combination 2
acupoints comination 2 includes the specific acupoint ST36 (Zusanli) and a distal acupoint PC6(Neiguan).
|
|
SHAM_COMPARATOR: sham acupoints combination
sham acupoints combination includes the specific acupoint ST36 (Zusanli) and a sham acupoint.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the score of GCSI
Time Frame: 4 weeks
|
GCSI means gastroparesis cardinal symptom index
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gastric emptying time
Time Frame: 4 weeks
|
4 weeks
|
gastrin concentrations
Time Frame: 4 weeks
|
4 weeks
|
motilin concentrations
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Zenghui Yue, Prof., Hunan University of Chinese Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (ANTICIPATED)
December 1, 2016
Study Registration Dates
First Submitted
October 31, 2015
First Submitted That Met QC Criteria
October 31, 2015
First Posted (ESTIMATE)
November 3, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
November 3, 2015
Last Update Submitted That Met QC Criteria
October 31, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014CB543102-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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