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

Not Applicable

• Conditions: Chronic Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic
• Interventions: Dietary Supplement: Eefooton oral solution; Dietary Supplement: Placebo oral solution

• Registration Number: NCT05227313
• Lead Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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 Timeline

• Study First Submitted: 2022-01-25
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-07
• Last Update Submitted: 2022-02-27
• Study Start: 2022-03-01
• Last Update Posted: 2022-03-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eefooton oral solution	Eefooton oral solution	20ml, 3 times per day (daily dose: 60 ml)
Eefooton oral solution	Placebo oral solution	20ml, 3 times per day (daily dose: 60 ml)
Placebo oral solution	Eefooton oral solution	oral solution matched placebo
Placebo oral solution	Placebo oral solution	oral solution matched placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
eGFR value	one month	The eGFR value is an important marker for kidney function

Trial Locations

Locations (1)

Department of Nephrology, Taipei Tzu Chi Hospital, Taipei, Taiwan; 🇨🇳 Taipei county, Taiwan