Different Acupoints Compatibility Difference of the Effect of Treatment of the Diabetic Gastroparesis

May 21, 2015 updated by: Tie Li, Changchun University of Chinese Medicine

Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect

With Diabetic gastroparesis as the research object, by the method of multi-center RCT and single cavity and different acupuncture acupoints compatibility treatment of diabetic gastroparesis, the inspection of gastric emptying, gastric dynamic inspection, such as validity checking means, for single cavity with different acupoints compatibility evaluate clinical efficacy of treatment of diabetic gastroparesis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In order to establish a spectrum of acupoints compatibility of the law, is clear about the factors affecting the compatibility effect of acupoints, the formation of strong operability of acupoints compatibility optimization evaluation method, the project choice of the clinical acupuncture and moxibustion have curative effect of diabetic gastroparesis as the breakthrough point of the study, carried out clinical multi-center RCT research, through objective and scientific evaluation method, comparing the effect of different acupoints compatibility.

Diabetic gastroparesis in clinical common disease, frequently-occurring disease, acupuncture curative effect is distinct, disease diagnosis, curative effect evaluation standard. Previous clinical data also show that the diabetic gastroparesis is acupuncture clinical diseases. This project by diabetic gastroparesis as the research object, research to better guide clinical practice, improve the clinical curative effect, promote acupuncture of the inheritance and innovation, promote scientification of acupuncture and moxibustion, modernization and internationalization, and will have broad prospect of application and significant scientific research value.

Study Type

Interventional

Enrollment (Anticipated)

99

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130117
        • Recruiting
        • The Affiliated Hospital To Changchun University of Chinese Medicine

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Diabetic Gastroparesis;
  • Aged 18-60 (including 18 and 60);
  • Fasting venous blood sugar ≤7.8mmol/L,2-hour post-meal blood glucose ≤ 13.6mmol/ L;
  • Diabetes more than 3 years;
  • Diet and exercise therapy or diet movement and exercise therapy based on the use of hypoglycemic drugs (except alpha glycosidase inhibitor) treatment, dose stable at least more than 3 months;
  • Rounding out the top three months did not participate in any clinical subjects;
  • Sign the informed consent and voluntary to participate in the study.

Exclusion Criteria:

  • Patients with reflux esophagitis;
  • Postoperative gastroparesis patients;
  • Ketoacidosis, non ketosis acute complications such as hypertonic coma;
  • Patients with acute cardiovascular disease, with severe trauma or surgery, severe infections, pregnancy or breast-feeding women;
  • Patients with myocardial infa,acute coronary syndrome (ACS),coronary revascularization;
  • Patients with severe liver disease, or the AST and/or ALT 2 times higher than normal ceiling;
  • Patients with Serum creatinine kidney damage, more than 140 umol/L;
  • Patients with obvious blood system diseases (either in person are not to be included in the item: Hb: men < 110 g/L, women < 100 g/L, the WBC < 3.5×109/L/L, PLT < 80×109/L);
  • Patients's systolic pressure≥180mmHg,Patients's diastolic pressure≥100mmHg;
  • Patients with Advanced malignant tumor or other serious wasting disease, infection and bleeding;
  • Endoscopy has the organic lesion such as peptic ulcer;
  • Disorders or do not fit the person and the growing experiment condition or severe complications;
  • Nearly four weeks of alpha glycosidase inhibitor drugs.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single point group (Zhongwan)
Patients will be acupuncture with Zhongwan(RN12).
Device: acupuncture
Patients will be acupuncture with Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks.
Device: acupuncture
Patients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment, follow-up after 4 weeks.
Device: acupuncture
Patients in Control group,will be acupuncture with at the junction of deltoid and biceps,needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks.
Other: Combination of He-Mu points group
Patients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12).
Device: acupuncture
Patients will be acupuncture with Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks.
Device: acupuncture
Patients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment, follow-up after 4 weeks.
Device: acupuncture
Patients in Control group,will be acupuncture with at the junction of deltoid and biceps,needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks.
Other: Control group
Patients in Control group,will be acupuncture with at the junction of deltoid and biceps.
Device: acupuncture
Patients will be acupuncture with Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks.
Device: acupuncture
Patients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment, follow-up after 4 weeks.
Device: acupuncture
Patients in Control group,will be acupuncture with at the junction of deltoid and biceps,needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gastroparesis Symptoms Rating Scale(GCSI)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
FBG(fasting blood-glucose)
Time Frame: 8 weeks
8 weeks
PPG(postprandial blood sugar)
Time Frame: 8 weeks
8 weeks
Gastric emptying check by Color ultrasonography
Time Frame: 8 weeks
8 weeks
Gastric emptying check by X rays
Time Frame: 8 weeks
8 weeks
Short form 36 health survey(SF-36)
Time Frame: 8 weeks
8 weeks
Self-rating anxiety scale(SAS)
Time Frame: 1 week
1 week
Self-Rating Depression Scale(SDS)
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changchun University of Chinese Medicine

Collaborators

Qilu Hospital of Shandong University
Jilin University
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Hengyang Traditional Chinese Medicine Hospital
Second People's Hospital of Hunan

Investigators

  • Study Chair: Fuchun Wang, master, Director

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

January 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Estimate)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChangchunUCM02

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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