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

Mackay Memorial Hospital

Status: Unknown

Conditions: Diabetic Nephropathy

Treatments: Device: acupressure by ankle band

Study type: Interventional

Funder types: Other

Identifiers

NCT02501772

14MMHIS139

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Sanyinjiao acupressor group

Experimental group

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

Treatment:

Device: acupressure by ankle band

Control Group

Sham Comparator group

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

Treatment:

Device: acupressure by ankle band