search
Back to results

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

Primary Purpose

Chronic Kidney Diseases, Renal Insufficiency, Chronic, Urologic Diseases

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Eefooton oral solution
Placebo oral solution
Sponsored by
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring eGFR, Chronic Kidney Diseases

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eefooton oral solution

Placebo oral solution

Arm Description

20ml, 3 times per day (daily dose: 60 ml)

oral solution matched placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

eGFR value
The eGFR value is an important marker for kidney function

Full Information

First Posted
January 25, 2022
Last Updated
February 27, 2022
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborators
Morris Enterprise Co.,Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05227313
Brief Title
Double-Blind, Placebo-Controlled Trial of Eefooton in Patients With Chronic Kidney Disease
Official Title
Evaluation Dietary Supplement" Eefooton" on the Quality of Life in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborators
Morris Enterprise Co.,Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Renal Insufficiency, Chronic, Urologic Diseases
Keywords
eGFR, Chronic Kidney Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eefooton oral solution
Arm Type
Experimental
Arm Description
20ml, 3 times per day (daily dose: 60 ml)
Arm Title
Placebo oral solution
Arm Type
Placebo Comparator
Arm Description
oral solution matched placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Eefooton oral solution
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo oral solution
Intervention Description
oral solution matched placebo
Primary Outcome Measure Information:
Title
Short-Form 36 Questionnaire
Description
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
Time Frame
2month
Secondary Outcome Measure Information:
Title
eGFR value
Description
The eGFR value is an important marker for kidney function
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Both male and female patients aged 20-85 years old are acceptable You must be able to come back at a specific time each month during the 6-month trial Exclusion Criteria: Drug abuse. Heart failure (stage 3-4) Mental illness (psychotic disorder, epilepsy, depression, panic disorder) Patients who have undergone dialysis or are expected to have a kidney transplant in the last three months The blood pressure still exceeds 150/90mmHg after using more than three antihypertensive drugs Pregnancy or planning to become pregnant or breastfeeding Malignant disease Acute illness (hepatitis, jaundice, acute myocardial infarction) in the last 3 months The patient is engaged in another research study. 3 months before entering the study or having used NSAIDs, anti-rejection drugs or performing imaging agent examinations during the study You have participated in other research study in the previous month You have drug dependence and drinking habits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuo-Cheng Lu, Ph.D
Organizational Affiliation
Taichung Tzu Chi Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chen-Shiung Wu, Ph.D
Organizational Affiliation
Taichung Tzu Chi Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ching-Hsiu Peng, MD
Organizational Affiliation
Taichung Tzu Chi Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ko-Lin Kuo, MD
Organizational Affiliation
Taichung Tzu Chi Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi-Chun Wang, MD
Organizational Affiliation
Taichung Tzu Chi Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ding-Jun Lin Lin, MD
Organizational Affiliation
Taichung Tzu Chi Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Szu-Chun Hung, MD
Organizational Affiliation
Taichung Tzu Chi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology, Taipei Tzu Chi Hospital, Taipei, Taiwan
City
Taipei county
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs