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

Not Applicable

• Conditions: Diabetic Nephropathy
• Interventions: Device: acupressure by ankle band

• Registration Number: NCT02501772
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-17
• Primary Completion: 2015-08
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	acupressure by ankle band	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
Sanyinjiao acupressor group	acupressure by ankle band	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

Primary Outcome Measures

Name	Time	Method
urinary spot albumin creatine excretion ratio (UACR) change	8 week duratoin

Trial Locations

Locations (1)

Mackay Memerial Hospital; 🇨🇳 Taipei, Taiwan