Back to resultsThe Evaluation of Effect of Sanyinjiao (SP6) Acupressure on Early Diabetic Nephropathy
Primary Purpose
Diabetic Nephropathy
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupressure by ankle band
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathy
Eligibility Criteria
Inclusion Criteria:
- age between 20 and 80 years old;
- HbA1c was lower than 9% according to the NGSP(National Glycohaemoglobin Standardisation Programme);
- estimated glomerular filtration rate (eGFR) was more than 60 mL/min/1.73 m2.
Exclusion Criteria:
- Hyperglycemic crisis, including HHS(hyperglycemic hyperosmolar syndrome) and DKA(diabetic ketoacidosis );
- Persist diabetes poorly control, Hemoglobin A1c [HbA1c] >9%;
- Endocrine disorders: such as abnormal function of thyroid, pituitary, and sex glands;
- heart diseases:such as arrhythmia, myocardial infarction, heart failure, or installed pacemaker;
- immune and allergic diseases: such as systemic lupus erythematosus and asthma;
- liver or kidney dysfunction: GOT or GPT(glutamate-pyruvate transaminase ) > 80 IU/L, eGFR<60 (mL/min);
- pregnant or lactating women;
- less than 6months postpartum;
- acute illness, fever, Lower urinary tract infection, NSAID(nonsteroidal antiinflammatory drug) administration;
- physical dysfunction because of stroke.
Sites / Locations
- Mackay Memerial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Sanyinjiao acupressor group
Control Group
Arm Description
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
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
Outcomes
Primary Outcome Measures
urinary spot albumin creatine excretion ratio (UACR) change
Secondary Outcome Measures
Full Information
NCT ID
NCT02501772
First Posted
July 15, 2015
Last Updated
November 21, 2019
Sponsor
Mackay Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02501772
Brief Title
The Evaluation of Effect of Sanyinjiao (SP6) Acupressure on Early Diabetic Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sanyinjiao acupressor group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
acupressure by ankle band
Primary Outcome Measure Information:
Title
urinary spot albumin creatine excretion ratio (UACR) change
Time Frame
8 week duratoin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 20 and 80 years old;
HbA1c was lower than 9% according to the NGSP(National Glycohaemoglobin Standardisation Programme);
estimated glomerular filtration rate (eGFR) was more than 60 mL/min/1.73 m2.
Exclusion Criteria:
Hyperglycemic crisis, including HHS(hyperglycemic hyperosmolar syndrome) and DKA(diabetic ketoacidosis );
Persist diabetes poorly control, Hemoglobin A1c [HbA1c] >9%;
Endocrine disorders: such as abnormal function of thyroid, pituitary, and sex glands;
heart diseases:such as arrhythmia, myocardial infarction, heart failure, or installed pacemaker;
immune and allergic diseases: such as systemic lupus erythematosus and asthma;
liver or kidney dysfunction: GOT or GPT(glutamate-pyruvate transaminase ) > 80 IU/L, eGFR<60 (mL/min);
pregnant or lactating women;
less than 6months postpartum;
acute illness, fever, Lower urinary tract infection, NSAID(nonsteroidal antiinflammatory drug) administration;
physical dysfunction because of stroke.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shih-Ming Chuang
Phone
886-919652673
Email
gopacer@hotmail.com
Facility Information:
Facility Name
Mackay Memerial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Chen Liu, master
Phone
886-975835741
12. IPD Sharing Statement
Learn more about this trial
The Evaluation of Effect of Sanyinjiao (SP6) Acupressure on Early Diabetic Nephropathy
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