Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02545036 |
| Other study ID # |
CMUH104-REC1-041 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
June 2015 |
| Est. completion date |
September 20, 2017 |
Study information
| Verified date |
July 2021 |
| Source |
China Medical University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The annual report of USRDS shows than Taiwan has the highest prevalence of
end-stage-renal-disease globally resulted in high prevalence dialysis rate. The major factors
associated with chronic renal failure are age, diabetes, hypertension, chronic
glomerulonephritis, metabolic syndrome, smoke, hepatitis C, painkiller and herbals. Chronic
kidney disease may lead to various metabolic, cardiovascular and neurological diseases. And
these possible prognostic factors associating with the disease progression and ultimately
increase the morbidity and mortality. End-stage renal failure is an irreversible course often
with clinical manifestations of edema, fatigue, anemia and uremic pruritus. Patients often
use Chinese medicine or acupuncture to help them to ease the symptom.
The aim of this study is to investigate the efficacy of combined Western medicine and
traditional Chinese medicine daycare model for chronic kidney disease patients. The study
approach to investigate whether combination of Western medicine and traditional Chinese
medicine daycare model can improve the clinical symptoms and quality of life as well as the
laboratory biochemistries data.
Description:
Keywords：chronic kidney disease , Day care, Traditional Chinese Medicine(TCM)
Background and purpose:
The annual report of USRDS shows than Taiwan has the highest prevalence of
end-stage-renal-disease globally resulted in high prevalence dialysis rate. The major factors
associated with chronic renal failure are age, diabetes, hypertension, chronic
glomerulonephritis, metabolic syndrome, smoke, hepatitis C, painkiller and herbals. Chronic
kidney disease may lead to various metabolic, cardiovascular and neurological diseases. And
these possible prognostic factors associating with the disease progression and ultimately
increase the morbidity and mortality. End-stage renal failure is an irreversible course often
with clinical manifestations of edema, fatigue, anemia and uremic pruritus. Patients often
use Chinese medicine or acupuncture to help them to ease the symptom.
The aim of this study is to investigate the efficacy of combined Western medicine and
traditional Chinese medicine daycare model for chronic kidney disease patients. The study
approach to investigate whether combination of Western medicine and traditional Chinese
medicine daycare model can improve the clinical symptoms and quality of life as well as the
laboratory biochemistries data.
Material and methods:
A total of 60 volunteers of patients with chronic kidney disease will be recruited from the
Chinese medicine or Western medicine clinics. After diagnosis by nephrology physician, 30
patients will be distributed to combinational Western and TCM daycare model, one time a week,
for 12 weeks (12 treatment in total). Another 30 patients will enter Western daycare model.
The assignment depends on the patients' own will. The TCM day care model will be provided by
a team work clinical care system organized by doctors, nurses, pharmacists and case managers.
This model will provide a comprehensive TCM care system for every visit. Laboratory
biochemistries analysis and other questionnaires including SF36 health survey, Pittsburgh
Sleep Quality Index, Beck Depression Inventory-II, FACIT-fatigue Scale and the 5-D itch scale
will be completed at baseline, 6weeks, and 12 weeks after join this study. Instrumental
examinations including heart rate variability and traditional Chinese medicine four
examinations will be given before and after intervention.
Predict results:
The investigators expect that the efficacy of this combined western medicine and traditional
Chinese medicine day care model will be superior to the "pre-ESRD prevention and education
program" which execute since 2006 in improving edema, fatigue, physical function and quality
of life. The effectiveness of combined therapy can be measured by questionnaires. Moreover,
the investigators will further speculate the mechanism by analyzing laboratory data.
