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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210519
Recruitment Status : Completed
First Posted : July 7, 2017
Results First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Nae-Cherng Yang, Chung Shan Medical University

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.

Condition or disease Intervention/treatment Phase
Renal Dialysis Dietary Supplement: Eleutherococcus senticosus Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : December 9, 2015
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Eleutherococcus senticosus
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
Dietary Supplement: Eleutherococcus senticosus
taken orally once/day for 90 days

Placebo Comparator: Placebo
Fructus Ziziphi Jujube concentrated juice15ml/vial
Other: Placebo
taken orally once/day for 90 days




Primary Outcome Measures :
  1. Erythropoietin (EPO) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported

  2. Hemoglobin (Hb) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported


Secondary Outcome Measures :
  1. Red Blood Cell (RBC) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported

  2. Hematocrit (Hct) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported

  3. Mean Corpuscular Hemoglobin Concentration (MCHC) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported

  4. Mean Corpuscular Volume (MCV) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported

  5. Mean Corpuscular Hemoglobin (MCH) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported

  6. Intact Parathyroid Hormone (iPTH) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported

  7. Tumor Necrosis Factor - Alpha (TNF-alpha) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported

  8. Interleukin 6 (IL-6) [ Time Frame: baseline and 3 months ]
    value at 3 months minus value at baseline reported



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210519


Sponsors and Collaborators
Chung Shan Medical University
Investigators
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Principal Investigator: Nae-Cherng Yang, Ph. D. Chun Shan Medical University
  Study Documents (Full-Text)

Documents provided by Nae-Cherng Yang, Chung Shan Medical University:
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Responsible Party: Nae-Cherng Yang, Associate Professor, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT03210519    
Other Study ID Numbers: CS15036
First Posted: July 7, 2017    Key Record Dates
Results First Posted: May 6, 2020
Last Update Posted: May 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No