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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Dialysis
• Intervention / Treatment: Dietary supplement: Eleutherococcus senticosus; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythropoietin (EPO)	value at 3 months minus value at baseline reported	baseline and 3 months
Hemoglobin (Hb)	value at 3 months minus value at baseline reported	baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Red Blood Cell (RBC)	value at 3 months minus value at baseline reported	baseline and 3 months
Hematocrit (Hct)	value at 3 months minus value at baseline reported	baseline and 3 months
Mean Corpuscular Hemoglobin Concentration (MCHC)	value at 3 months minus value at baseline reported	baseline and 3 months
Mean Corpuscular Volume (MCV)	value at 3 months minus value at baseline reported	baseline and 3 months
Mean Corpuscular Hemoglobin (MCH)	value at 3 months minus value at baseline reported	baseline and 3 months
Intact Parathyroid Hormone (iPTH)	value at 3 months minus value at baseline reported	baseline and 3 months
Tumor Necrosis Factor - Alpha (TNF-alpha)	value at 3 months minus value at baseline reported	baseline and 3 months
Interleukin 6 (IL-6)	value at 3 months minus value at baseline reported	baseline and 3 months

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Investigators: Principal Investigator: Nae-Cherng Yang, Ph. D., Chun Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2015
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: July 4, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CS15036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No