Double-Blind, Placebo-Controlled Trial of Eefooton in Patients With Chronic Kidney Disease

NCT ID: NCT05227313

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double blind

Study Groups

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Eefooton oral solution

20ml, 3 times per day (daily dose: 60 ml)

Group Type EXPERIMENTAL

Eefooton oral solution

Intervention Type DIETARY_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 solution

Intervention Type DIETARY_SUPPLEMENT

oral solution matched placebo

Placebo oral solution

oral solution matched placebo

Group Type PLACEBO_COMPARATOR

Eefooton oral solution

Intervention Type DIETARY_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 solution

Intervention Type DIETARY_SUPPLEMENT

oral solution matched placebo

Interventions

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Eefooton oral solution

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo oral solution

oral solution matched placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Morris Enterprise Co.,Ltd.

UNKNOWN

Sponsor Role collaborator

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kuo-Cheng Lu, Ph.D

Role: STUDY_CHAIR

Taichung Tzu Chi Hospital

Chen-Shiung Wu, Ph.D

Role: STUDY_DIRECTOR

Taichung Tzu Chi Hospital

Ching-Hsiu Peng, MD

Role: PRINCIPAL_INVESTIGATOR

Taichung Tzu Chi Hospital

Ko-Lin Kuo, MD

Role: PRINCIPAL_INVESTIGATOR

Taichung Tzu Chi Hospital

Yi-Chun Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Taichung Tzu Chi Hospital

Ding-Jun Lin Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Taichung Tzu Chi Hospital

Szu-Chun Hung, MD

Role: PRINCIPAL_INVESTIGATOR

Taichung Tzu Chi Hospital

Locations

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Department of Nephrology, Taipei Tzu Chi Hospital, Taipei, Taiwan

Taipei County, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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IRB No.10-FS-088

Identifier Type: -

Identifier Source: org_study_id

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