Evaluation Dietary Supplement" Eefooton" on the Quality of Life in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Short-Form 36 Questionnaire
研究概览
简要总结
This phase II study, 24-week, double-blind, study evaluated Eefooton's safety and efficacy for patients with CKD stage 3 to 4 Not on dialysis.
详细描述
The purpose of this clinical observation and research is to evaluate the eGFR changes in the renal function of patients with chronic kidney disease combination the Eefooton oral solution and commonly used chemical drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blind
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
- 否
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
- •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
研究组 & 干预措施
Eefooton oral solution
20ml, 3 times per day (daily dose: 60 ml)
干预措施: Eefooton oral solution (Dietary Supplement)
Eefooton oral solution
20ml, 3 times per day (daily dose: 60 ml)
干预措施: Placebo oral solution (Dietary Supplement)
Placebo oral solution
oral solution matched placebo
干预措施: Eefooton oral solution (Dietary Supplement)
Placebo oral solution
oral solution matched placebo
干预措施: Placebo oral solution (Dietary Supplement)
结局指标
主要结局
Short-Form 36 Questionnaire
时间窗: 2month
The SF-36 questionnaire consists of eight health concepts, each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. (1) physical functioning, (2) role limitations due to physical health, (3) bodily pain, (4) general health perceptions, (5) vitality (energy/fatigue), (6) social functioning, (7) role limitations due to emotional health, (8) general mental health
次要结局
- eGFR value(one month)