Clinical trial NCT05227313: Double-Blind, Placebo-Controlled Trial of Eefooton in Patients With Chronic Kidney Disease
Official title: Evaluation Dietary Supplement" Eefooton" on the Quality of Life in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Keywords: eGFR
Chronic Kidney Diseases
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
Collaborators: name: Morris Enterprise Co.,Ltd.
First posted: 2022-02-07
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Short-Form 36 Questionnaire
timeFrame: 2month
Secondary outcomes:
measure: eGFR value
timeFrame: one month
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Department of Nephrology, Taipei Tzu Chi Hospital, Taipei, Taiwan
Study officials:
affiliation: Taichung Tzu Chi Hospital
name: Kuo-Cheng Lu, Ph.D
role: STUDY_CHAIR
affiliation: Taichung Tzu Chi Hospital
name: Chen-Shiung Wu, Ph.D
role: STUDY_DIRECTOR
affiliation: Taichung Tzu Chi Hospital
name: Ching-Hsiu Peng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taichung Tzu Chi Hospital
name: Ko-Lin Kuo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taichung Tzu Chi Hospital
name: Yi-Chun Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taichung Tzu Chi Hospital
name: Ding-Jun Lin Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taichung Tzu Chi Hospital
name: Szu-Chun Hung, MD
role: PRINCIPAL_INVESTIGATOR
References: