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

NCT ID: NCT04940117

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-10-31

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.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

blood test data before and after taking

Checking eGRF value before and after taking Eefooton oral solution

Group Type: EXPERIMENTAL

Eefooton oral solution

Intervention Type: DIETARY_SUPPLEMENT

Check eGFR value, liver and kidney function every month

Interventions

Eefooton oral solution

Check eGFR value, liver and kidney function every month

Intervention Type: DIETARY_SUPPLEMENT

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

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role: lead

Responsible Party

Jin-Shuen Chen

Chair of IRB

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-Shuen Chen, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Veterans General Hospital.

Sam-Chiang Wu, Ph.D

Role: STUDY_DIRECTOR

WU SAM-CHIANG Medical clinic

Locations

WU SAM-CHIANG Medical clinic

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

IRB No. KSVGH21-CT5-19

Identifier Type: -

Identifier Source: org_study_id