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Completed

NCT Number: NCT04940117

Effects of the Eefooton on eGFR and QoL in Chronic Kidney Disease Patients.

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WU SAM-CHIANG Medical clinic

Kaohsiung City, 802, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

If you have any of the following conditions, you will not be able to participate in this research project:

  • 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

Treatment and study plan

Eefooton oral solution

Dietary Supplement

Check eGFR value, liver and kidney function every month

Primary outcomes

  1. QoL

    Time frame: one months

    The SF-36 questionnaire as assessment of the safety that consists physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (fatigue), social functioning, role limitations due to emotional health, and general mental health.

Other outcomes

  1. eGFR

    Time frame: one months

    The eGFR value is an important marker for kidney function. The GFR unit is ml/min/1.73m2

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

Improve eGFR in Chronic Kidney Disease

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2021
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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