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

NCT ID: NCT02501772

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-12-31

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.

Conditions

Diabetic Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

acupressure by ankle band

Intervention Type: DEVICE

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

Group Type: SHAM_COMPARATOR

acupressure by ankle band

Intervention Type: DEVICE

Interventions

acupressure by ankle band

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chunag Shih-Ming

Mackay Memorial Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mackay Memerial Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Shih-Ming Chuang

Role: CONTACT

gopacer@hotmail.com

886-919652673

Facility Contacts

Sung-Chen Liu, master

Role: primary

886-975835741

Other Identifiers

14MMHIS139

Identifier Type: -

Identifier Source: org_study_id