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

Evaluation Dietary Supplement Eefooton on the Quality of Life in Chronic Kidney Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05227313
Enrollment
120
Registered
2022-02-07
Start date
2022-03-01
Completion date
2024-12-31
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Renal Insufficiency, Chronic, Urologic Diseases

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

DIETARY_SUPPLEMENTEefooton oral solution

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.

DIETARY_SUPPLEMENTPlacebo oral solution

oral solution matched placebo

Sponsors

Morris Enterprise Co.,Ltd.
CollaboratorUNKNOWN
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

double blind

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Short-Form 36 Questionnaire2monthThe 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

MeasureTime frameDescription
eGFR valueone monthThe eGFR value is an important marker for kidney function

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026