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To Evaluate the Efficacy of Eleutherococcus Senticosus for Subjects Under Renal Dialysis

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ClinicalTrials.gov Identifier: NCT03210519
Recruitment Status : Completed
First Posted : July 7, 2017
Results First Posted : May 6, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Nae-Cherng Yang, Chung Shan Medical University

Tracking Information
First Submitted Date  ICMJE July 3, 2017
First Posted Date  ICMJE July 7, 2017
Results First Submitted Date  ICMJE April 13, 2020
Results First Posted Date  ICMJE May 6, 2020
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE December 9, 2015
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • Erythropoietin (EPO) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported
  • Hemoglobin (Hb) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported
Original Primary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
  • Erythropoietin (EPO) [ Time Frame: baseline, at 1 month, at 2 months, at 3 months ]
    Monthly dose
  • Hb [ Time Frame: baseline, at 1 month, at 2 months, at 3 months ]
    Hemoglobin
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • Red Blood Cell (RBC) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported
  • Hematocrit (Hct) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported
  • Mean Corpuscular Hemoglobin Concentration (MCHC) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported
  • Mean Corpuscular Volume (MCV) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported
  • Mean Corpuscular Hemoglobin (MCH) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported
  • Intact Parathyroid Hormone (iPTH) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported
  • Tumor Necrosis Factor - Alpha (TNF-alpha) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported
  • Interleukin 6 (IL-6) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported
Original Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
  • RBC [ Time Frame: baseline, at 1 month, at 2 months, at 3 months ]
    Red Blood Cell
  • Hct [ Time Frame: baseline, at 1 month, at 2 months, at 3 months ]
    Hematocrit
  • MCHC [ Time Frame: baseline, at 1 month, at 2 months, at 3 months ]
    Mean corpuscular hemoglobin concentration
  • MCV [ Time Frame: baseline, at 1 month, at 2 months, at 3 months ]
    Mean corpuscular volume
  • MCH [ Time Frame: baseline, at 1 month, at 2 months, at 3 months ]
    Mean Corpuscular Hemoglobin
  • iPTH [ Time Frame: baseline and at 3 months ]
    Intact Parathyroid Hormone
  • TNF-alpha [ Time Frame: baseline and at 3 months ]
    Tumor necrosis factor - alpha
  • IL-6 [ Time Frame: baseline and at 3 months ]
    Interleukin 6
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Efficacy of Eleutherococcus Senticosus for Subjects Under Renal Dialysis
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Eleutherococcus Senticosus for Anti-inflammation and Improvement of Erythropoietin Hyporesponsiveness in Subjects Under Renal Dialysis
Brief Summary This is a randomized, double-blind, placebo-controlled, parallel comparison trial to evaluate the efficacy and safety of Eleutherococcus Senticosus taken orally by patients under regular dialysis. Eligible subjects with written consent were randomized into one of the two groups: A. Acanthopanax senticosus (30mg/vial); B. Placebo. After 2-4 weeks of run-in period, the study subjects were asked to take the investigational products orally for 90 days in order to evaluate the effects of oral Eleutherococcus Senticosus liquid on the markers of inflammation, anemia, and safety, and to compare the efficacy among oral Acanthopanax senticosus and placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Renal Dialysis
Intervention  ICMJE
  • Dietary Supplement: Eleutherococcus senticosus
    taken orally once/day for 90 days
  • Other: Placebo
    taken orally once/day for 90 days
Study Arms  ICMJE
  • Experimental: Eleutherococcus senticosus
    Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
    Intervention: Dietary Supplement: Eleutherococcus senticosus
  • Placebo Comparator: Placebo
    Fructus Ziziphi Jujube concentrated juice15ml/vial
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2020)
21
Original Actual Enrollment  ICMJE
 (submitted: July 4, 2017)
19
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Under regular dialysis for at least 3 months
  • Hemoglobin (Hb) <11 g/L after regular Erythropoietin (EPO) treatment
  • Subjects with written informed consent form

Exclusion Criteria:

  • Use of steroid or high dose of antiplatelet drug (e.g. Aspirin >300mg) within one month
  • Had surgery, myocardial infarction, or tumor within 12 weeks
  • Currently use of antibiotic treatment for acute infection
  • Pregnant women
  • Reticulocyte>40 x 10^9
  • Anemia (ferritin <100ng/mL and Transferrin Saturation (TSAT) <20%)
  • Urea reduction ratio <65% or single pool Kt/V < 1.0 (hemodialysis patients) or total weekly Kt/V<1.7 (peritoneal dialysis patients)
  • Sudden change of eating habit within one month
  • Expected life less than six months or with unstable medical conditions
  • Known history of allergic reaction to the investigational products
  • With acute diseases and judged by the investigator to be ineligible to participate
  • Received melatonin, androgen therapy or blood transfusion within two months
  • Received any trial medications within 30 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03210519
Other Study ID Numbers  ICMJE CS15036
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nae-Cherng Yang, Chung Shan Medical University
Study Sponsor  ICMJE Chung Shan Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nae-Cherng Yang, Ph. D. Chun Shan Medical University
PRS Account Chung Shan Medical University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP