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The Evaluation of Effect of Sanyinjiao (SP6) Acupressure on Early Diabetic Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501772
Recruitment Status : Recruiting
First Posted : July 17, 2015
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Chunag Shih-Ming, Mackay Memorial Hospital

Brief Summary:
For diabetic patient with persisted albuminuria under the intensive control on blood pressure and blood glucose, the non-invasive method of acupressure at Sanyinjiao (SP6) is easy to use and significantly effect on albuminuria reduction in patients of diabetic nephropathy.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Device: acupressure by ankle band Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Actual Study Start Date : September 2014
Actual Primary Completion Date : August 2015
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sanyinjiao acupressor group
In addition to maintain current treatment included oral anti-hyperglycemia agent and ACEI(angiotensin-converting enzyme inhibitor ) or ARB, subjects should wear ankle band at Sanyinjiao point ( calf , ankle on the foot tip 3 inch ), with the thumb pressing daily five minutes later and carry more than four hours for 8 weeks
Device: acupressure by ankle band
Sham Comparator: Control Group
In the control group, ankle band was place as same as the those for the SA(Sanyinjiao acupressor) group, but was wearing at the acupoint of Sanyinjiao with anti- surface without pressure. It was applied four hours per day for 8 weeks
Device: acupressure by ankle band



Primary Outcome Measures :
  1. urinary spot albumin creatine excretion ratio (UACR) change [ Time Frame: 8 week duratoin ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age between 20 and 80 years old;
  2. HbA1c was lower than 9% according to the NGSP(National Glycohaemoglobin Standardisation Programme);
  3. estimated glomerular filtration rate (eGFR) was more than 60 mL/min/1.73 m2.

Exclusion Criteria:

  1. Hyperglycemic crisis, including HHS(hyperglycemic hyperosmolar syndrome) and DKA(diabetic ketoacidosis );
  2. Persist diabetes poorly control, Hemoglobin A1c [HbA1c] >9%;
  3. Endocrine disorders: such as abnormal function of thyroid, pituitary, and sex glands;
  4. heart diseases:such as arrhythmia, myocardial infarction, heart failure, or installed pacemaker;
  5. immune and allergic diseases: such as systemic lupus erythematosus and asthma;
  6. liver or kidney dysfunction: GOT or GPT(glutamate-pyruvate transaminase ) > 80 IU/L, eGFR<60 (mL/min);
  7. pregnant or lactating women;
  8. less than 6months postpartum;
  9. acute illness, fever, Lower urinary tract infection, NSAID(nonsteroidal antiinflammatory drug) administration;
  10. physical dysfunction because of stroke.

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): NCT02501772


Contacts
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Contact: Shih-Ming Chuang 886-919652673 gopacer@hotmail.com

Locations
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Taiwan
Mackay Memerial Hospital Recruiting
Taipei, Taiwan
Contact: Sung-Chen Liu, master    886-975835741      
Sponsors and Collaborators
Mackay Memorial Hospital
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Responsible Party: Chunag Shih-Ming, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT02501772    
Other Study ID Numbers: 14MMHIS139
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases