NCT02452489

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

2.9 years

First QC Date

May 20, 2015

Last Update Submit

May 21, 2015

Conditions

Diabetic Gastroparesis

Keywords

Different acupoints compatibility

Outcome Measures

Primary Outcomes (1)

  • Gastroparesis Symptoms Rating Scale(GCSI)

    8 weeks

Secondary Outcomes (7)

  • FBG(fasting blood-glucose)

    8 weeks

  • PPG(postprandial blood sugar)

    8 weeks

  • Gastric emptying check by Color ultrasonography

    8 weeks

  • Gastric emptying check by X rays

    8 weeks

  • Short form 36 health survey(SF-36)

    8 weeks

  • +2 more secondary outcomes

Study Arms (3)

Single point group (Zhongwan)

OTHER

Patients will be acupuncture with Zhongwan(RN12).

Device: acupuncture

Combination of He-Mu points group

OTHER

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

Device: acupuncture

Control group

OTHER

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

Device: acupuncture

Interventions

acupunctureDEVICE

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.

Single point group (Zhongwan)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital To Changchun University of Chinese Medicine

Changchun, Jilin, 130117, China

RECRUITING

Related Publications (1)

  • Liu R, He M, Zhao X, Sun M, Cao J, Wang X, Wang X, Zhao S, Wang F, Li T. Effects of stimulating single acupoint and combination acupoints on diabetic gastroparesis: A randomised controlled trial study. J Tradit Complement Med. 2024 Jan 23;14(4):446-455. doi: 10.1016/j.jtcme.2024.01.008. eCollection 2024 Jul.

    PMID: 39035685DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Fuchun Wang, master

    Director

    STUDY CHAIR

Central Study Contacts

Tie Li, Ph.D

CONTACT

+86 0431 86714973zusanli_1999@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
973 project management deputy director of the office

Study Record Dates

First Submitted

May 20, 2015

First Posted

May 22, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

August 1, 2018

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

CN(1)