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Trial record 1 of 2 for:    eefooton
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Double-Blind, Placebo-Controlled Trial of Eefooton in Patients With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05227313
Recruitment Status : Enrolling by invitation
First Posted : February 7, 2022
Last Update Posted : March 2, 2022
Sponsor:
Collaborator:
Morris Enterprise Co.,Ltd.
Information provided by (Responsible Party):
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Dietary Supplement: Eefooton oral solution Dietary Supplement: Placebo oral solution Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double blind
Primary Purpose: Treatment
Official Title: Evaluation Dietary Supplement" Eefooton" on the Quality of Life in Chronic Kidney Disease
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Short-Form 36 Questionnaire [ Time Frame: 2month ]
    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 :
  1. eGFR value [ Time Frame: one month ]
    The eGFR value is an important marker for kidney function


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05227313


Locations
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Taiwan
Department of Nephrology, Taipei Tzu Chi Hospital, Taipei, Taiwan
Taipei county, Taiwan
Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Morris Enterprise Co.,Ltd.
Investigators
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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
More Information
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Responsible Party: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier: NCT05227313    
Other Study ID Numbers: IRB No.10-FS-088
First Posted: February 7, 2022    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:
eGFR
Chronic Kidney Diseases
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Chronic Disease
Disease Attributes
Pathologic Processes
Pharmaceutical Solutions