Double-Blind, Placebo-Controlled Trial of Eefooton in Patients With Chronic Kidney Disease

Buddhist Tzu Chi Medical Foundation

Status: Invitation-only

Conditions: Chronic Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases

Treatments: Dietary Supplement: Eefooton oral solution; Dietary Supplement: Placebo oral solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05227313

IRB No.10-FS-088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Eefooton oral solution

Experimental group

Description:

20ml, 3 times per day (daily dose: 60 ml)

Treatment:

Dietary Supplement: Placebo oral solution

Dietary Supplement: Eefooton oral solution

Placebo oral solution

Placebo Comparator group

Description:

oral solution matched placebo

Treatment:

Dietary Supplement: Placebo oral solution

Dietary Supplement: Eefooton oral solution