NCT03210519

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

Completed NA Results posted Last updated 16 September 2020

What this trial tests

NA trial testing Eleutherococcus senticosus in Renal Dialysis in 21 participants. Completed in 30 June 2017.

Timeline

9 December 2015

Primary endpoint
30 June 2017

30 June 2017

Quick facts

Lead sponsor	Chung Shan Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	21
Start date	9 December 2015
Primary completion	30 June 2017
Estimated completion	30 June 2017

Drugs / interventions tested

• Eleutherococcus senticosus
• Placebo

Conditions studied

• Renal Dialysis — all drugs for Renal Dialysis →

Sponsor

Chung Shan Medical University

Who can join

Adults 20 to 80, any sex, with Renal Dialysis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Erythropoietin (EPO) Primary · baseline and 3 months

value at 3 months minus value at baseline reported

Group	Value	95% CI
Eleutherococcus Senticosus	-6000.0	± 5916.5
Placebo	-1714.3	± 6264.1

Hemoglobin (Hb) Primary · baseline and 3 months

value at 3 months minus value at baseline reported

Group	Value	95% CI
Eleutherococcus Senticosus	1.0	± 1.1
Placebo	-0.1	± 0.8

Red Blood Cell (RBC) Secondary · baseline and 3 months

value at 3 months minus value at baseline reported

Group	Value	95% CI
Eleutherococcus Senticosus	25.1	± 35.6
Placebo	-7.8	± 28.7

Hematocrit (Hct) Secondary · baseline and 3 months

value at 3 months minus value at baseline reported

Group	Value	95% CI
Eleutherococcus Senticosus	2.5	± 3.2
Placebo	-0.3	± 2.6

Mean Corpuscular Hemoglobin Concentration (MCHC) Secondary · baseline and 3 months

value at 3 months minus value at baseline reported

Group	Value	95% CI
Eleutherococcus Senticosus	-0.5	± 0.3
Placebo	-0.3	± 1.0

Mean Corpuscular Volume (MCV) Secondary · baseline and 3 months

value at 3 months minus value at baseline reported

Group	Value	95% CI
Eleutherococcus Senticosus	1.3	± 3.0
Placebo	1.7	± 2.2

Mean Corpuscular Hemoglobin (MCH) Secondary · baseline and 3 months

value at 3 months minus value at baseline reported

Group	Value	95% CI
Eleutherococcus Senticosus	0.0	± 1.1
Placebo	0.3	± 0.7

Intact Parathyroid Hormone (iPTH) Secondary · baseline and 3 months

value at 3 months minus value at baseline reported

Group	Value	95% CI
Eleutherococcus Senticosus	28.6	± 240.5
Placebo	-97.9	± 149.3

Tumor Necrosis Factor - Alpha (TNF-alpha) Secondary · baseline and 3 months

value at 3 months minus value at baseline reported

Group	Value	95% CI
Eleutherococcus Senticosus	-17.2	± 16.1
Placebo	-14.9	± 19.6

Interleukin 6 (IL-6) Secondary · baseline and 3 months

value at 3 months minus value at baseline reported

Group	Value	95% CI
Eleutherococcus Senticosus	-20.3	± 28.7
Placebo	-0.7	± 41.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 and 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Eleutherococcus Senticosus

Serious: 0/11 (0%)

Deaths: 0/11

Placebo

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (1 terms — click to expand)

Reaction	System	Eleutherococcus Senticosus	Placebo
Subjects complained uncomfortable	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT03210519 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.