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

Chronic Kidney Diseases Clinical Trial

Official title:

Improve eGFR in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04940117
• Other study ID #: IRB No. KSVGH21-CT5-19
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: August 2023
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Eefooton oral solution
Check eGFR value, liver and kidney function every month

Locations

Country	Name	City	State
Taiwan	WU SAM-CHIANG Medical clinic	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	eGFR	The eGFR value is an important marker for kidney function. The GFR unit is ml/min/1.73m2	one months
Primary	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.	one months