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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05227313
• Other study ID #: IRB No.10-FS-088
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2022
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• 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:

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
• Renal Insufficiency, Chronic
• Urologic Diseases

Intervention

Dietary Supplement:
• Eefooton oral solution
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.
• Placebo oral solution
oral solution matched placebo

Locations

Country	Name	City	State
Taiwan	Department of Nephrology, Taipei Tzu Chi Hospital, Taipei, Taiwan	Taipei county

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	Morris Enterprise Co.,Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	eGFR value	The eGFR value is an important marker for kidney function	one month