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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03210519

Enrollment

Registered

2017-07-07

Start date

2015-12-09

Completion date

2017-06-30

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Dialysis

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.

Interventions

DIETARY_SUPPLEMENTEleutherococcus senticosus

taken orally once/day for 90 days

OTHERPlacebo

taken orally once/day for 90 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Mean Corpuscular Hemoglobin Concentration (MCHC)	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
Mean Corpuscular Hemoglobin (MCH)	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
Tumor Necrosis Factor - Alpha (TNF-alpha)	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
Intact Parathyroid Hormone (iPTH)	baseline and 3 months	value at 3 months minus value at baseline reported
Hematocrit (Hct)	baseline and 3 months	value at 3 months minus value at baseline reported

Participant flow

Participants by arm

Arm	Count
Eleutherococcus Senticosus Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial	11
Placebo Fructus Ziziphi Jujube concentrated juice15ml/vial	10
Total	21

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	2	0

Baseline characteristics

Characteristic	Placebo	Total	Eleutherococcus Senticosus
Age, Continuous	55.8 years STANDARD_DEVIATION 11.3	60.1 years STANDARD_DEVIATION 12.7	64 years STANDARD_DEVIATION 13.1
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment Taiwan	10 participants	21 participants	11 participants
Sex: Female, Male Female	6 Participants	11 Participants	5 Participants
Sex: Female, Male Male	4 Participants	10 Participants	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 11	0 / 10
other Total, other adverse events	2 / 11	0 / 10
serious Total, serious adverse events	0 / 11	0 / 10