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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Urologic Diseases; Chronic Kidney Diseases; Renal Insufficiency, Chronic
• Intervention / Treatment: Dietary supplement: Eefooton oral solution; Dietary supplement: Placebo oral solution

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei county, Taiwan
    • Department of Nephrology, Taipei Tzu Chi Hospital, Taipei, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Eefooton oral solution; 20ml, 3 times per day (daily dose: 60 ml)	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.; Dietary supplement: Placebo oral solution; oral solution matched placebo
PLACEBO_COMPARATOR: Placebo oral solution; oral solution matched placebo	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.; Dietary supplement: Placebo oral solution; oral solution matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
eGFR value	The eGFR value is an important marker for kidney function	one month

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Collaborators: Morris Enterprise Co.,Ltd.
• Investigators: Study Chair: Kuo-Cheng Lu, Ph.D, Taichung Tzu Chi Hospital; Study Director: Chen-Shiung Wu, Ph.D, Taichung Tzu Chi Hospital; Principal Investigator: Ching-Hsiu Peng, MD, Taichung Tzu Chi Hospital; Principal Investigator: Ko-Lin Kuo, MD, Taichung Tzu Chi Hospital; Principal Investigator: Yi-Chun Wang, MD, Taichung Tzu Chi Hospital; Principal Investigator: Ding-Jun Lin Lin, MD, Taichung Tzu Chi Hospital; Principal Investigator: Szu-Chun Hung, MD, Taichung Tzu Chi Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (ACTUAL): February 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 27, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: eGFR; Chronic Kidney Diseases
• Additional Relevant MeSH Terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases; Pharmaceutical Solutions
• Other Study ID Numbers: IRB No.10-FS-088

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No