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
- 25
- 试验地点
- 2
- 主要终点
- Change from Baseline in Nerve Conduction Velocity at 3 months
研究概览
简要总结
Diabetic nephropathy is not only an important issue of national health, but also a disease that TCM can play an important role. The aim of this project is to build up a TCM clinical daycare model for diabetic nephropathy patients, and to establish a teaching platform for TCM trainees. The TCM daycare model will be provided by a team organized by doctors, nurses, pharmacists, nutritionist and case managers. This model will provide a comprehensive TCM care system to improve the clinical symptoms and quality of life of diabetic nephropathy patients. The teaching platform of the TCM daycare clinics for diabetic nephropathy patients will provide a good clinical training environment for the trainees. They can learn how to take care ofdiabetic nephropathy patients by the lectures and the clinical practice experiences in the daycare clinics. They can also learn a holistic approach, a patient-centered healthcare service. This teaching model will strengthen the clinical training of TCM and enhance the international competitiveness of TCM doctors
详细描述
keywords᧶Diabetic Nephropathy, Daycare, Traditional Chinese Medicine (TCM) Diabetic nephropathy is not only an important issue of national health, but also a disease that TCM can play an important role. The aim of this project is to build up a TCM clinical daycare model for diabetic nephropathy patients, and to establish a teaching platform for TCM trainees. The TCM daycare model will be provided by a team organized by doctors, nurses, pharmacists, nutritionist and case managers. This model will provide a comprehensive TCM care system to improve the clinical symptoms and quality of life of diabetic nephropathy patients. The teaching platform of the TCM daycare clinics for diabetic nephropathy patients will provide a good clinical training environment for the trainees. They can learn how to take care ofdiabetic nephropathy patients by the lectures and the clinical practice experiences in the daycare clinics. They can also learn a holistic approach, a patient-centered healthcare service. This teaching model will strengthen the clinical training of TCM and enhance the international competitiveness of TCM doctors.
Material and methods
A total of 30 volunteers of patients with Diabetic nephropathy will be recruited from the Chinese medicine or Western medicine clinics. After diagnosis by nephrology physician, 15 patients will be distributed to combinational Western and TCM daycare model, one time a week, for 12 weeks (12 treatment in total). Another 15 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, the Galer Jensen Neuropathic Pain Scale, SF-BPI, TC-AE, and constitution in Chinese medicine questionnaire will be completed at 1 weeks, and 12 weeks after join this study. Instrumental examinations including heart rate variability 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 improving neuropathy symptoms, edema, fatigue, physical function and quality of life in diabetic nephropathy patients. The effectiveness of combined therapy can be measured by questionnaires. Moreover, the investigators will further speculate the mechanism by analyzing laboratory data.
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
- •Diabetic peripheral neuropathy based on subjective symptoms
- •Fit diabetes mellitus nephropathy definition by National Kidney Foundation's Kidney Disease Outcome Quality Initiative（NKF-KDOQI) stage II~IV and fit American Diabetic Association Criteria by stable glycemic control (HbA1C ≤ 9%, with ± 0.5% variation in the previous 3months).
- •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
- •primary cause of neurologic disorder was not diabetes (e.g., alcoholic neuropathy, carpal tunnel syndrome, chemotherapy induced neuropathy)
- •receiving other experimental medications for DPN or any other medication that affects symptoms of DPN
- •ankle brachial pressure index of ≤ 0.8
- •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.
结局指标
主要结局
Change from Baseline in Nerve Conduction Velocity at 3 months
时间窗: 1st,12th week
a test to see how fast electrical signals move through a nerve. This test is done along with electromyography (EMG) to assess the muscles for abnormalities.
次要结局
- Traditional Chinese Medicine body constitution questionnaire(1st,12th week)
- Galer Jensen Neuropathic Pain Scale(1st,12th week)
- heart rate variability(1st,12th week)
- The Functional Assessment of Chronic Illness Therapy-fatigue scale(1st,12th week)
- Brief Pain Inventory (BPI) short form(1st,12th week)
- Change from Baseline in Creatinine(mg/dL) at 3 months(1st,12th week)
- The Pittsburgh Sleep Quality Index(1st,12th week)
- Common Terminology Criteria for Adverse Events(1st,12th week)
- Change from Baseline in GFR(ml/min/1.73m2)at 3 months(1st,12th week)
- Beck Depression Inventory II(1st,12th week)
- 36-Item Short Form Health Survey(1st,12th week)