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

NCT02501772 | Unknown DMC

• 1 other identifier: 14MMHIS139
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• urinary spot albumin creatine excretion ratio (UACR) change

  8 week duratoin

Study Arms (2)

Sanyinjiao acupressor group

EXPERIMENTAL

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

Device: acupressure by ankle band

Control Group

SHAM COMPARATOR

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

Device: acupressure by ankle band

Interventions

acupressure by ankle band DEVICE

Control Group; Sanyinjiao acupressor group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay Memerial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Shih-Ming Chuang

CONTACT

886-919652673; gopacer@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mackay Memorial Hospital

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 17, 2015
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2019
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

TW (1)