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Trial record 2 of 2 for:    eefooton
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Effects of the Eefooton on eGFR and QoL in Chronic Kidney Disease Patients.

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: NCT04940117
Recruitment Status : Enrolling by invitation
First Posted : June 25, 2021
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Jin-Shuen Chen, Kaohsiung Veterans General Hospital.

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Chronic 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 : July 1, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 31, 2022

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: 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
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Primary Outcome Measures :
  1. Short-Form 36 Questionnaire [ Time Frame: 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 [ 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

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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:

  • 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
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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): NCT04940117


Locations
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Taiwan
WU SAM-CHIANG Medical clinic
Kaohsiung, Taiwan, 802
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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Principal Investigator: Jin-Shuen Chen, Ph.D Kaohsiung Veterans General Hospital.
Study Director: Sam-Chiang Wu, Ph.D WU SAM-CHIANG Medical clinic
More Information
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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: June 25, 2021    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Jin-Shuen Chen, Kaohsiung Veterans General Hospital.:
eGFR
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes