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

Not Applicable

Completed

• Conditions: Renal Dialysis
• Interventions: Dietary Supplement: Eleutherococcus senticosus; Other: Placebo

• Registration Number: NCT03210519
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-09
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-07
• Results First Submitted: 2020-04-13
• Results First Submitted QC: 2020-04-27
• Results First Posted: 2020-05-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eleutherococcus senticosus	Eleutherococcus senticosus	Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
Placebo	Placebo	Fructus Ziziphi Jujube concentrated juice15ml/vial

Primary Outcome Measures

Name	Time	Method
Erythropoietin (EPO)	baseline and 3 months	value at 3 months minus value at baseline reported
Hemoglobin (Hb)	baseline and 3 months	value at 3 months minus value at baseline reported

Secondary Outcome Measures

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