Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial

NCT ID: NCT02594397

Last Updated: 2015-11-03

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Brief Summary

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

Detailed Description

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Conditions

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Gastroparesis Diabetes Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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acupoints combination 1

acupoints comination 1 includes the specific acupoint ST36 (Zusanli) and a local acupoint CV12 (Zhongwan).

Group Type EXPERIMENTAL

acupoints combination 1

Intervention Type OTHER

acupoints combination 2

acupoints comination 2 includes the specific acupoint ST36 (Zusanli) and a distal acupoint PC6(Neiguan).

Group Type ACTIVE_COMPARATOR

acupoints combination 2

Intervention Type OTHER

sham acupoints combination

sham acupoints combination includes the specific acupoint ST36 (Zusanli) and a sham acupoint.

Group Type SHAM_COMPARATOR

sham acupoints combination

Intervention Type OTHER

Interventions

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acupoints combination 1

Intervention Type OTHER

acupoints combination 2

Intervention Type OTHER

sham acupoints combination

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zenghui Yue, Prof.

Role: STUDY_CHAIR

Hunan University of Chinese Medicine

Central Contacts

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Mailan Liu, Dr.

Role: CONTACT

86-731-88458187

Ping Li

Role: CONTACT

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.

Reference Type DERIVED
PMID: 32399130 (View on PubMed)

Other Identifiers

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2014CB543102-2

Identifier Type: -

Identifier Source: org_study_id

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