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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02501772
Other study ID # 14MMHIS139
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date December 2019

Study information

Verified date November 2019
Source Mackay Memorial Hospital
Contact Shih-Ming Chuang
Phone 886-919652673
Email gopacer@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2019
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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


Intervention

Device:
acupressure by ankle band


Locations

Country Name City State
Taiwan Mackay Memerial Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary urinary spot albumin creatine excretion ratio (UACR) change 8 week duratoin
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