Chronic Kidney DiseasesNCT05227313
Double-Blind, Placebo-Controlled Trial of Eefooton in Patients With Chronic Kidney Disease
A study testing Eefooton oral solution in people with Chronic Kidney Diseases and Renal Insufficiency, Chronic, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Chronic Kidney Diseases, Renal Insufficiency, Chronic, Urologic Diseases
- What is being tested?
- Eefooton oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2022to 31 Dec 2024
- 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
- 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
Show all 12Show fewer
- 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.
Taiwan1 site
Department of Nephrology, Taipei Tzu Chi Hospital, Taipei, Taiwan
Taipei County
About this study
Official title: Evaluation Dietary Supplement" Eefooton" on the Quality of Life in Chronic Kidney Disease
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.
Read the 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.
- Being tested
- Eefooton oral solution, Placebo oral solution
- Keywords
- eGFR, Chronic Kidney Diseases
- Medical subject headings
- Renal Insufficiency, Chronic, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eefooton oral solutionDietary supplement
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.
Placebo oral solutionDietary supplement
oral solution matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Eefooton oral solution | Experimental | 20ml, 3 times per day (daily dose: 60 ml) Receives: Dietary Supplement: Eefooton oral solution; Dietary Supplement: Placebo oral solution |
| Placebo oral solution | Placebo comparator | oral solution matched placebo Receives: Dietary Supplement: Eefooton oral solution; Dietary Supplement: Placebo oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-Form 36 Questionnaire
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
Measured: 2month
Secondary outcomes (1)
eGFR value
The eGFR value is an important marker for kidney function
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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
- Randomised
- Intervention model
- Single group
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Morris Enterprise Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Kuo-Cheng Lu, Ph.D, Study chair, Taichung Tzu Chi HospitalChen-Shiung Wu, Ph.D, Study director, Taichung Tzu Chi HospitalChing-Hsiu Peng, MD, Principal investigator, Taichung Tzu Chi HospitalKo-Lin Kuo, MD, Principal investigator, Taichung Tzu Chi HospitalYi-Chun Wang, MD, Principal investigator, Taichung Tzu Chi HospitalDing-Jun Lin Lin, MD, Principal investigator, Taichung Tzu Chi HospitalSzu-Chun Hung, MD, Principal investigator, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227313
- Sponsor's protocol ID
- IRB No.10-FS-088
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Dietary Supplement" Eefooton" on the Quality of Life in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05227313
- Acronym / sponsor ID
- IRB No.10-FS-088
- Keywords
- eGFR, Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Collaborators
- Morris Enterprise Co.,Ltd.
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Feb 2022 (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.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Eefooton oral solution | Experimental | Dietary Supplement: Eefooton oral solution, Dietary Supplement: Placebo oral solution20ml, 3 times per day (daily dose: 60 ml) |
| Placebo oral solution | Placebo comparator | Dietary Supplement: Eefooton oral solution, Dietary Supplement: Placebo oral solutionoral solution matched placebo |
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 (12 listed)
- 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
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 solutionEefooton 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 | Eefooton oral solution, Placebo oral solution |
| Placebo oral solutionoral solution matched placebo | Dietary supplement | Eefooton oral solution, Placebo oral solution |
Primary outcome
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
1 secondary outcome
eGFR value
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
Kuo-Cheng Lu, Ph.D study chair
Taichung Tzu Chi Hospital
Chen-Shiung Wu, Ph.D study director
Taichung Tzu Chi Hospital
Ching-Hsiu Peng, MD principal investigator
Taichung Tzu Chi Hospital
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 and Renal Insufficiency, Chronic, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation 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 12 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: status not confirmed, as of the sponsor's last update on 2 Mar 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Short-Form 36 Questionnaire (time frame: 2month). 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 2 Mar 2022.