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

NCT05227313 | Unknown DMC

• 1 other identifier: IRB No.10-FS-088
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases

Keywords

eGFR; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  2month

Secondary Outcomes (1)

• eGFR value

  one month

Study Arms (2)

Eefooton oral solution

EXPERIMENTAL

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

Dietary Supplement: Eefooton oral solution; Dietary Supplement: Placebo oral solution

Placebo oral solution

PLACEBO COMPARATOR

oral solution matched placebo

Dietary Supplement: Eefooton oral solution; Dietary Supplement: Placebo oral solution

Interventions

Eefooton oral solution 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.

Eefooton oral solution; Placebo oral solution

Placebo oral solution DIETARY_SUPPLEMENT

oral solution matched placebo

Eefooton oral solution; Placebo oral solution

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:

• 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

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead
• Morris Enterprise Co.,Ltd.: collaborator

Study Sites (1)

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

Taipei County, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Urologic Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney 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

• Kuo-Cheng Lu, Ph.D

  Taichung Tzu Chi Hospital

  STUDY CHAIR

• Chen-Shiung Wu, Ph.D

  Taichung Tzu Chi Hospital

  STUDY DIRECTOR

• Ching-Hsiu Peng, MD

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

• Ko-Lin Kuo, MD

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

• Yi-Chun Wang, MD

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

• Ding-Jun Lin Lin, MD

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

• Szu-Chun Hung, MD

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 7, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

TW (1)