Skip to main content
OpenTrials
Completed

NCT Number: NCT03210519

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Dialysis

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eleutherococcus senticosus

Dietary Supplement

taken orally once/day for 90 days

Placebo

Other

taken orally once/day for 90 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 7, 2017
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.