Diabetic NephropathyNCT02501772
The Evaluation of Effect of Sanyinjiao (SP6) Acupressure on Early Diabetic Nephropathy
A study testing acupressure by ankle band in people with Diabetic Nephropathy, run by Mackay Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- acupressure by ankle band
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Mackay Memerial Hospital
Taipei
Sung-Chen Liu, master, 886-975835741
About this study
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
- Being tested
- acupressure by ankle band
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressure by ankle bandDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: acupressure by ankle band |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary spot albumin creatine excretion ratio (UACR) change
Measured: 8 week duratoin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunag Shih-Ming, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501772
- Sponsor's protocol ID
- 14MMHIS139
- Status last verified
- Nov 2019
- First submitted
- 15 Jul 2015
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Effect of Sanyinjiao (SP6) Acupressure on Early Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT02501772
- Acronym / sponsor ID
- 14MMHIS139
- Conditions
- Diabetic Nephropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sanyinjiao acupressor group | Experimental | Device: acupressure by ankle bandIn 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 |
| Control Group | Sham comparator | Device: acupressure by ankle bandIn 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupressure by ankle band | Device | Control Group, Sanyinjiao acupressor group |
Primary outcome
urinary spot albumin creatine excretion ratio (UACR) change
Time frame: 8 week duratoin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
Related trials for Diabetic Nephropathy
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure by ankle band in people with Diabetic Nephropathy, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shih-Ming Chuang (886-919652673, gopacer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary spot albumin creatine excretion ratio (UACR) change (time frame: 8 week duratoin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.