Clinical Study of Combined Western Medicine and Traditional Chinese Medicine Daycare Model for Chronic Kidney Disease Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change from Baseline in GFR(ml/min/1.73m2)at 3 months
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fit CKD definition by National Kidney Foundation's Kidney Disease Outcome Quality Initiative（NKF-KDOQI, pre-ESRD stage IIIb~IV (GFR: 15-44).
- •at least 20 years old volunteers.
- •The participants had no allergy to acupuncture needle in the past, or without contraindications to acupuncture treatment.
- •The participants agreed to join the trial and sign informed consent form after thorough explanation.
排除标准
- •Age less than 20 years old.
- •Using immunosuppressive drug or receiving chemotherapy.
- •Had substance abuse in the past, or having substance abuse.
- •Pregnancy women or breastfeeding women.
- •Mental or behavioral disorders which leads to inability to cooperation.
- •Arrhythmia patients who have pacemaker.
- •Patient who have skin infection or wound infection near acupoints.
- •Patient who have coagulation abnormalities or low platelet count by blood tests (platelet≤150000 / uL).
- •Participating other clinical trials.
- •Patient with serious diseases such as myocardial infarction, severe arrhythmia, heart failure, chronic obstructive airway disease, or cancer.
- •Patients who have limb edema and severe skin lesions not suitable for acupuncture or massage.
- •Patients who took Chinese herbal medicine or received acupuncture treatment in the past 2 weeks.
- •Patients who disagree to sign informed consent form.
结局指标
主要结局
Change from Baseline in GFR(ml/min/1.73m2)at 3 months
时间窗: baseline,12th week
Change from Baseline in Creatinine(mg/dL) at 3 months
时间窗: baseline,12th week
次要结局
- The Pittsburgh Sleep Quality Index(baseline, 6th ,12th week)
- FACIT-fatigue scale(baseline, 6th ,12th week)
- The 5-D itch scale(baseline, 6th ,12th week)
- heart rate variability(baseline, 12th week)
- SF-36 Health Survey(baseline, 6th ,12th week)
- TCM diagnosis(baseline, 12th week)
- Beck Depression Inventory II(baseline, 6th ,12th week)
- TCM body constitution questionnaire(baseline, 6th ,12th week)
- skin pruritus on Visual Analogue Scale(baseline, 6th ,12th week)