Evaluation Dietary Supplement" Eefooton" on the Quality of Life in Chronic Kidney Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Short-Form 36 Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
double blind
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Eefooton oral solution
20ml, 3 times per day (daily dose: 60 ml)
Intervention: Eefooton oral solution (Dietary Supplement)
Eefooton oral solution
20ml, 3 times per day (daily dose: 60 ml)
Intervention: Placebo oral solution (Dietary Supplement)
Placebo oral solution
oral solution matched placebo
Intervention: Eefooton oral solution (Dietary Supplement)
Placebo oral solution
oral solution matched placebo
Intervention: Placebo oral solution (Dietary Supplement)
Outcomes
Primary Outcomes
Short-Form 36 Questionnaire
Time Frame: 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 Outcomes
- eGFR value(one month)