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临床试验/NCT04940117
NCT04940117已完成不适用

Improve eGFR in Chronic Kidney Disease

Kaohsiung Veterans General Hospital.2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
QoL

研究概览

简要总结

Chronic renal failure is a chronic and progressive disease with a poor prognosis. In recent years, it can be found in many literature reports that traditional Chinese medicine therapy has obvious effects on early and mid-term chronic renal failure. It can not only improve clinical symptoms, but also block or delay the process of renal failure. It is relatively rare that compounds such as compounds. The side effects of drugs may be used in combination with compound drugs to improve clinical side effects and help patients improve their quality of life to complete the treatment course. It can provide clinicians with another choice in treatment. A previous study confirmed that the use of Eefooton oral solution of Chinese herbal medicine concentrate has a significant protective effect on the kidneys that have not undergone hemodialysis. Eefooton is extracted from Rhodiola, Huang Qi, American Ginseng, Dang Ginseng, and Ligustrum lucidum by biotechnology. It has immunomodulatory effects, anti-oxidation and anti-inflammatory effects, and regulates calcium metabolism. The purpose of this clinical observation and research is to evaluate the eGFR changes in the renal function of patients with chronic kidney disease with the combination of Eefooton oral solution and commonly used chemical drugs.

详细描述

The Blood test items consisted Blood urea nitrogen (BUN), Serum creatinine (SCr), estimated glomerular filtration rate (eGFR), serum Uric acid, plasma Albumin (ALB), Hemoglobin (Hb), Alkaline phosphatase (ALP), Serum Glutamic-Oxalocetic Transaminase (SGOT), Serum glutamic pyruvic transaminase (SGPT), Glucose(AC), Serum sodium, Serum potassium, Corrected calcium , Phosphorus (Blood). Glycated hemoglobin (HbA1c), Triglyceride (TG), Total cholesterol (Chol), High-density lipoprotein (HDL), Low-density lipoprotein (LDL). During the entire research process did not change diet, lifestyle, habits and the use of drugs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Patients with renal failure with Eefooton oral solution for six months and blood test to check the changes in eGFR values

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with chronic kidney disease who have signed the subject's consent and the glomerular filtration rate (eGFR) is less than 59ml/min/1.73m2
  • Both male and female patients aged 20-85 years old are acceptable
  • You must be able to come back at a specific time each month during the 6-month trial

排除标准

  • If you have any of the following conditions, you will not be able to participate in this research project:
  • Drug abuse.
  • Heart failure (stage 3-4)
  • Mental illness (psychotic disorder, epilepsy, depression, panic disorder)
  • Patients who have undergone dialysis or are expected to have a kidney transplant in the last three months
  • The blood pressure still exceeds 150/90mmHg after using more than three antihypertensive drugs
  • Pregnancy or planning to become pregnant or breastfeeding
  • Malignant disease
  • Acute illness (hepatitis, jaundice, acute myocardial infarction) in the last 3 months
  • The patient is engaged in another research study.
  • 3 months before entering the study or having used NSAIDs, anti-rejection drugs or performing imaging agent examinations during the study
  • You have participated in other research study in the previous month
  • You have drug dependence and drinking habits

结局指标

主要结局

QoL

时间窗: one months

The SF-36 questionnaire as assessment of the safety that consists physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (fatigue), social functioning, role limitations due to emotional health, and general mental health.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Shuen Chen

Chair of IRB

Kaohsiung Veterans General Hospital.

研究点 (2)

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