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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: Eefooton oral solution
* Dietary Supplement: Placebo oral solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eefooton oral solution<br>20ml, 3 times per day (daily dose: 60 ml) | Dietary Supplement: Eefooton oral solution<br>* 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.<br>Dietary Supplement: Placebo oral solution<br>* oral solution matched placebo<br>|
| Placebo Comparator: Placebo oral solution<br>oral solution matched placebo | Dietary Supplement: Eefooton oral solution<br>* 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.<br>Dietary Supplement: Placebo oral solution<br>* oral solution matched placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Form 36 Questionnaire | 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 | 2month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR value | The eGFR value is an important marker for kidney function | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eGFR, Chronic Kidney Diseases