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

• Sponsor: Kaohsiung Veterans General Hospital. (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04940117
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 5.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases	Dietary Supplement: Eefooton oral solution	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Chronic Kidney Disease before dialysisChronic 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
• Primary Purpose: Treatment
• Official Title: Improve eGFR in Chronic Kidney Disease
• Actual Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: blood test data before and after taking Checking eGRF value before and after taking Eefooton oral solution	Dietary Supplement: Eefooton oral solution; Check eGFR value, liver and kidney function every month

Outcome Measures

Primary Outcome Measures

1. Short-Form 36 Questionnaire [one month]

   The SF-36 questionnaire consists of eight health concepts (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 Outcome Measures

1. eGFR value [one month]

   The eGFR value is an important marker for kidney function

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	WU SAM-CHIANG Medical clinic	Kaohsiung		Taiwan	802

Sponsors and Collaborators

• Kaohsiung Veterans General Hospital.

Investigators

• Principal Investigator: Jin-Shuen Chen, Ph.D, Kaohsiung Veterans General Hospital.
• Study Director: Sam-Chiang Wu, Ph.D, WU SAM-CHIANG Medical clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jin-Shuen Chen, Chair of IRB, Kaohsiung Veterans General Hospital.
• ClinicalTrials.gov Identifier: NCT04940117
• Other Study ID Numbers: IRB No. KSVGH21-CT5-19
• First Posted: Jun 25, 2021
• Last Update Posted: Jul 7, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jin-Shuen Chen, Chair of IRB, Kaohsiung Veterans General Hospital.: eGFR
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

No Results Posted as of Jul 7, 2021