Chronic Kidney DiseasesNCT04940117
Effects of the Eefooton on eGFR and QoL in Chronic Kidney Disease Patients.
A study testing Eefooton oral solution in people with Chronic Kidney Diseases, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Eefooton oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improve eGFR in Chronic Kidney Disease
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Eefooton oral solution
- Keywords
- eGFR
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eefooton oral solutionDietary supplement
Check eGFR value, liver and kidney function every month
| Study group | Role | What they receive |
|---|---|---|
| blood test data before and after taking | Experimental | Checking eGRF value before and after taking Eefooton oral solution Receives: Dietary Supplement: Eefooton oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Jul 2021
- Primary completion31 Aug 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Chronic Kidney Disease before dialysis
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Shuen Chen, Kaohsiung Veterans General Hospital.
- Investigators
- Jin-Shuen Chen, Ph.D, Principal investigator, Kaohsiung Veterans General Hospital.Sam-Chiang Wu, Ph.D, Study director, WU SAM-CHIANG Medical clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940117
- Sponsor's protocol ID
- IRB No. KSVGH21-CT5-19
- Status last verified
- Aug 2023
- First submitted
- 22 Jun 2021
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improve eGFR in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04940117
- Acronym / sponsor ID
- IRB No. KSVGH21-CT5-19
- Conditions
- Chronic Kidney Diseases
- Keywords
- eGFR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Chronic Kidney Disease before dialysis
| Arm | Type | Receives |
|---|---|---|
| blood test data before and after taking | Experimental | Dietary Supplement: Eefooton oral solutionChecking eGRF value before and after taking Eefooton oral solution |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eefooton oral solutionCheck eGFR value, liver and kidney function every month | Dietary supplement | blood test data before and after taking |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Shuen Chen, Ph.D principal investigator
Kaohsiung Veterans General Hospital.
Sam-Chiang Wu, Ph.D study director
WU SAM-CHIANG Medical clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eefooton oral solution in people with Chronic Kidney Diseases, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoL (time frame: one months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.