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

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ClinicalTrials.gov Identifier: NCT02452489
Recruitment Status : Unknown
Verified May 2015 by Tie Li, Changchun University of Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : May 22, 2015
Last Update Posted : May 22, 2015
Sponsor:
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
Information provided by (Responsible Party):
Tie Li, Changchun University of Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Diabetic Gastroparesis Device: acupuncture Phase 1

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  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
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.

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 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.

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




Primary Outcome Measures :
  1. Gastroparesis Symptoms Rating Scale(GCSI) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. FBG(fasting blood-glucose) [ Time Frame: 8 weeks ]
  2. PPG(postprandial blood sugar) [ Time Frame: 8 weeks ]
  3. Gastric emptying check by Color ultrasonography [ Time Frame: 8 weeks ]
  4. Gastric emptying check by X rays [ Time Frame: 8 weeks ]
  5. Short form 36 health survey(SF-36) [ Time Frame: 8 weeks ]
  6. Self-rating anxiety scale(SAS) [ Time Frame: 1 week ]
  7. Self-Rating Depression Scale(SDS) [ Time Frame: 1 week ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452489


Contacts
Contact: Tie Li, Ph.D +86 0431 86714973 zusanli_1999@126.com

Locations
China, Jilin
The Affiliated Hospital To Changchun University of Chinese Medicine Recruiting
Changchun, Jilin, China, 130117
Contact: Tie Li, Ph.D    +86 0431 86714973    zusanli_1999@126.com   
Sponsors and Collaborators
Changchun University of Chinese Medicine
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
Investigators
Study Chair: Fuchun Wang, master director

Responsible Party: Tie Li, 973 project management deputy director of the office, Changchun University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT02452489     History of Changes
Other Study ID Numbers: ChangchunUCM02
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

Keywords provided by Tie Li, Changchun University of Chinese Medicine:
Different acupoints compatibility

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms