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

Primary Purpose

Diabetic Gastroparesis

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

acupuncture

About this trial

This is an interventional treatment trial for Diabetic Gastroparesis focused on measuring Different acupoints compatibility

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Affiliated Hospital To Changchun University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Single point group (Zhongwan)

Combination of He-Mu points group

Control group

Arm Description

Patients will be acupuncture with Zhongwan(RN12).

Patients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12).

Patients in Control group,will be acupuncture with at the junction of deltoid and biceps.

Outcomes

Primary Outcome Measures

Gastroparesis Symptoms Rating Scale(GCSI)

Secondary Outcome Measures

FBG(fasting blood-glucose)

PPG(postprandial blood sugar)

Gastric emptying check by Color ultrasonography

Gastric emptying check by X rays

Short form 36 health survey(SF-36)

Self-rating anxiety scale(SAS)

Self-Rating Depression Scale(SDS)

Full Information

NCT ID

NCT02452489

First Posted

May 20, 2015

Last Updated

May 21, 2015

Sponsor

Changchun University of Chinese Medicine

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02452489

Brief Title

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

Official Title

Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changchun University of Chinese Medicine

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Gastroparesis

Keywords

Different acupoints compatibility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single point group (Zhongwan)

Arm Type

Other

Arm Description

Patients will be acupuncture with Zhongwan(RN12).

Arm Title

Combination of He-Mu points group

Arm Type

Other

Arm Description

Patients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12).

Arm Title

Control group

Arm Type

Other

Arm Description

Patients in Control group,will be acupuncture with at the junction of deltoid and biceps.

Intervention Type

Device

Intervention Name(s)

acupuncture

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

acupuncture

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

acupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

Gastroparesis Symptoms Rating Scale(GCSI)

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

FBG(fasting blood-glucose)

Time Frame

8 weeks

Title

PPG(postprandial blood sugar)

Time Frame

8 weeks

Title

Gastric emptying check by Color ultrasonography

Time Frame

8 weeks

Title

Gastric emptying check by X rays

Time Frame

8 weeks

Title

Short form 36 health survey(SF-36)

Time Frame

8 weeks

Title

Self-rating anxiety scale(SAS)

Time Frame

1 week

Title

Self-Rating Depression Scale(SDS)

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tie Li, Ph.D

Phone

+86 0431 86714973

zusanli_1999@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fuchun Wang, master

Organizational Affiliation

Director

Official's Role

Study Chair

Facility Information:

Facility Name

The Affiliated Hospital To Changchun University of Chinese Medicine

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130117

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tie Li, Ph.D

Phone

+86 0431 86714973

zusanli_1999@126.com

12. IPD Sharing Statement

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

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