Chronic Kidney Diseases, Renal Insufficiency, Chronic, Urologic Diseases
Conditions
Keywords
eGFR, Chronic Kidney Diseases
Brief summary
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.
Detailed description
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.
Interventions
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.
oral solution matched placebo
Sponsors
Study design
Masking description
double blind
Intervention model description
Parallel Assignment
Eligibility
Inclusion criteria
1. 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 2. Both male and female patients aged 20-85 years old are acceptable 3. You must be able to come back at a specific time each month during the 6-month trial
Exclusion criteria
1. Drug abuse. 2. Heart failure (stage 3-4) 3. Mental illness (psychotic disorder, epilepsy, depression, panic disorder) 4. Patients who have undergone dialysis or are expected to have a kidney transplant in the last three months 5. The blood pressure still exceeds 150/90mmHg after using more than three antihypertensive drugs 6. Pregnancy or planning to become pregnant or breastfeeding 7. Malignant disease 8. Acute illness (hepatitis, jaundice, acute myocardial infarction) in the last 3 months 9. The patient is engaged in another research study. 10. 3 months before entering the study or having used NSAIDs, anti-rejection drugs or performing imaging agent examinations during the study 11. You have participated in other research study in the previous month 12. You have drug dependence and drinking habits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-Form 36 Questionnaire | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| eGFR value | one month | The eGFR value is an important marker for kidney function |
Countries
Taiwan