NCT03210519

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

May 6, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

July 3, 2017

Results QC Date

April 13, 2020

Last Update Submit

September 14, 2020

Conditions

Renal Dialysis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Red Blood Cell (RBC)

    baseline and 3 months

  • Hematocrit (Hct)

    baseline and 3 months

  • Mean Corpuscular Hemoglobin Concentration (MCHC)

    baseline and 3 months

  • Mean Corpuscular Volume (MCV)

    baseline and 3 months

  • Mean Corpuscular Hemoglobin (MCH)

    baseline and 3 months

  • +3 more secondary outcomes

Study Arms (2)

Eleutherococcus senticosus

EXPERIMENTAL

Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial

Dietary Supplement: Eleutherococcus senticosus

Placebo

PLACEBO COMPARATOR

Fructus Ziziphi Jujube concentrated juice15ml/vial

Other: Placebo

Interventions

Eleutherococcus senticosusDIETARY_SUPPLEMENT

taken orally once/day for 90 days

Eleutherococcus senticosus
PlaceboOTHER

taken orally once/day for 90 days

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Under regular dialysis for at least 3 months
  • Hemoglobin (Hb) \<11 g/L after regular Erythropoietin (EPO) treatment
  • Subjects with written informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Siberian ginseng root

Results Point of Contact

Title
Dr. Nae-Cherng Yang
Organization
Department of Nutrition, Chung Shan Medical University
naeman@csmu.edu.tw
886-0936810214

Study Officials

  • Nae-Cherng Yang, Ph. D.

    Chun Shan Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 7, 2017

Study Start

December 9, 2015

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

September 16, 2020

Results First Posted

May 6, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share