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

NCT04940117 | Completed

• 1 other identifier: IRB No. KSVGH21-CT5-19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

eGFR

Outcome Measures

Primary Outcomes (1)

• QoL

  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.

  one months

Other Outcomes (1)

• eGFR

  one months

Study Arms (1)

blood test data before and after taking

EXPERIMENTAL

Checking eGRF value before and after taking Eefooton oral solution

Dietary Supplement: Eefooton oral solution

Interventions

Eefooton oral solution DIETARY_SUPPLEMENT

Check eGFR value, liver and kidney function every month

blood test data before and after taking

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

WU SAM-CHIANG Medical clinic

Kaohsiung City, 802, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Jin-Shuen Chen, Ph.D

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

• Sam-Chiang Wu, Ph.D

  WU SAM-CHIANG Medical clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients with renal failure with Eefooton oral solution for six months and blood test to check the changes in eGFR values
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of IRB

Model Details: Chronic Kidney Disease before dialysis

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 25, 2021
• Study Start: July 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)