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Effects of the Eefooton on eGFR and QoL in Chronic Kidney Disease Patients.

Primary Purpose

Chronic Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Eefooton oral solution
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring eGFR

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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:

  • If you have any of the following conditions, you will not be able to participate in this research project:

    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

Sites / Locations

  • WU SAM-CHIANG Medical clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

blood test data before and after taking

Arm Description

Checking eGRF value before and after taking Eefooton oral solution

Outcomes

Primary Outcome Measures

QoL
The SF-36 questionnaire as assessment of the safety that consists physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (fatigue), social functioning, role limitations due to emotional health, and general mental health.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2021
Last Updated
August 20, 2023
Sponsor
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT04940117
Brief Title
Effects of the Eefooton on eGFR and QoL in Chronic Kidney Disease Patients.
Official Title
Improve eGFR in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic renal failure is a chronic and progressive disease with a poor prognosis. In recent years, it can be found in many literature reports that traditional Chinese medicine therapy has obvious effects on early and mid-term chronic renal failure. It can not only improve clinical symptoms, but also block or delay the process of renal failure. It is relatively rare that compounds such as compounds. The side effects of drugs may be used in combination with compound drugs to improve clinical side effects and help patients improve their quality of life to complete the treatment course. It can provide clinicians with another choice in treatment. A previous study confirmed that the use of Eefooton oral solution of Chinese herbal medicine concentrate has a significant protective effect on the kidneys that have not undergone hemodialysis. 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. The purpose of this clinical observation and research is to evaluate the eGFR changes in the renal function of patients with chronic kidney disease with the combination of Eefooton oral solution and commonly used chemical drugs.
Detailed Description
The Blood test items consisted Blood urea nitrogen (BUN), Serum creatinine (SCr), estimated glomerular filtration rate (eGFR), serum Uric acid, plasma Albumin (ALB), Hemoglobin (Hb), Alkaline phosphatase (ALP), Serum Glutamic-Oxalocetic Transaminase (SGOT), Serum glutamic pyruvic transaminase (SGPT), Glucose(AC), Serum sodium, Serum potassium, Corrected calcium , Phosphorus (Blood). Glycated hemoglobin (HbA1c), Triglyceride (TG), Total cholesterol (Chol), High-density lipoprotein (HDL), Low-density lipoprotein (LDL). During the entire research process did not change diet, lifestyle, habits and the use of drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
eGFR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Chronic Kidney Disease before dialysis
Masking
None (Open Label)
Masking Description
Patients with renal failure with Eefooton oral solution for six months and blood test to check the changes in eGFR values
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
blood test data before and after taking
Arm Type
Experimental
Arm Description
Checking eGRF value before and after taking Eefooton oral solution
Intervention Type
Dietary Supplement
Intervention Name(s)
Eefooton oral solution
Intervention Description
Check eGFR value, liver and kidney function every month
Primary Outcome Measure Information:
Title
QoL
Description
The SF-36 questionnaire as assessment of the safety that consists physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (fatigue), social functioning, role limitations due to emotional health, and general mental health.
Time Frame
one months
Other Pre-specified Outcome Measures:
Title
eGFR
Description
The eGFR value is an important marker for kidney function. The GFR unit is ml/min/1.73m2
Time Frame
one months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: If you have any of the following conditions, you will not be able to participate in this research project: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Shuen Chen, Ph.D
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sam-Chiang Wu, Ph.D
Organizational Affiliation
WU SAM-CHIANG Medical clinic
Official's Role
Study Director
Facility Information:
Facility Name
WU SAM-CHIANG Medical clinic
City
Kaohsiung
ZIP/Postal Code
802
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of the Eefooton on eGFR and QoL in Chronic Kidney Disease Patients.

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