GastroparesisADG-RCTNCT02594397
Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial
A study testing acupoints combination 1 and acupoints combination 2 in people with Gastroparesis and Diabetes Complications, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine.
Trial summary
The purpose of this study is to determine whether the different combination of acupoints have different effect on diabetic gastroparalysis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastroparesis, Diabetes Complications
- What is being tested?
- acupoints combination 1 and acupoints combination 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
No sites are listed yet.
Ping Li contact
About this study
The purpose of this study is to determine whether the different combination of acupoints have different effect on diabetic gastroparalysis.
- Conditions
- Gastroparesis, Diabetes Complications
- Being tested
- acupoints combination 1, acupoints combination 2, sham acupoints combination
- Medical subject headings
- Gastroparesis, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupoints combination 1Other
acupoints combination 2Other
sham acupoints combinationOther
| Study group | Role | What they receive |
|---|---|---|
| acupoints combination 1 | Experimental | acupoints comination 1 includes the specific acupoint ST36 (Zusanli) and a local acupoint CV12 (Zhongwan). Receives: Other: acupoints combination 1 |
| acupoints combination 2 | Active comparator | acupoints comination 2 includes the specific acupoint ST36 (Zusanli) and a distal acupoint PC6(Neiguan). Receives: Other: acupoints combination 2 |
| sham acupoints combination | Sham comparator | sham acupoints combination includes the specific acupoint ST36 (Zusanli) and a sham acupoint. Receives: Other: sham acupoints combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
the score of GCSI
GCSI means gastroparesis cardinal symptom index
Measured: 4 weeks
Secondary outcomes (3)
Gastric emptying time
Measured: 4 weeks
gastrin concentrations
Measured: 4 weeks
motilin concentrations
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zenghui Yue, Prof., Study chair, Hunan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594397
- Sponsor's protocol ID
- 2014CB543102-2
- Acronym
- ADG-RCT
- Status last verified
- Sep 2015
- First submitted
- 31 Oct 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
Publications
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.
PubMed 32399130
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02594397
- Acronym / sponsor ID
- ADG-RCT / 2014CB543102-2
- Conditions
- Gastroparesis, Diabetes Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the different combination of acupoints have different effect on diabetic gastroparalysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupoints combination 1 | Experimental | Other: acupoints combination 1acupoints comination 1 includes the specific acupoint ST36 (Zusanli) and a local acupoint CV12 (Zhongwan). |
| acupoints combination 2 | Active comparator | Other: acupoints combination 2acupoints comination 2 includes the specific acupoint ST36 (Zusanli) and a distal acupoint PC6(Neiguan). |
| sham acupoints combination | Sham comparator | Other: sham acupoints combinationsham acupoints combination includes the specific acupoint ST36 (Zusanli) and a sham acupoint. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupoints combination 1 | Other | acupoints combination 1 |
| acupoints combination 2 | Other | acupoints combination 2 |
| sham acupoints combination | Other | sham acupoints combination |
Primary outcome
the score of GCSI
Time frame: 4 weeks
GCSI means gastroparesis cardinal symptom index
3 secondary outcomes
Gastric emptying time
Time frame: 4 weeks
gastrin concentrations
Time frame: 4 weeks
motilin concentrations
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Derived from this study: PubMed 32399130Xuefen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Li contact
Zenghui Yue, Prof. study chair
Hunan University of Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing acupoints combination 1 and acupoints combination 2 in people with Gastroparesis and Diabetes Complications, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mailan Liu, Dr. (86-731-88458187, 445007305@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the score of GCSI (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02594397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.