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

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ClinicalTrials.gov Identifier: NCT03210519
Recruitment Status : Completed
First Posted : July 7, 2017
Results First Posted : May 6, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Nae-Cherng Yang, Chung Shan Medical University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Renal Dialysis
Interventions Dietary Supplement: Eleutherococcus senticosus
Other: Placebo
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eleutherococcus Senticosus Placebo
Hide Arm/Group Description Participants first received screening tests for up to 30 days. Eligible subjects were then given the investigational products (Acanthopanax senticosus-mono formula 30mg/vial and Fructus Ziziphi Jujube concentrated juice15ml/vial) to be taken orally once/day for 90 days. Patients with hyperacidity and gastroesophageal reflux were recommended to take it after meals. Participants first received screening tests for up to 30 days. Eligible subjects were then given the investigational products (Fructus Ziziphi Jujube concentrated juice15ml/vial) to be taken orally once/day for 90 days. Patients with hyperacidity and gastroesophageal reflux were recommended to take it after meals.
Period Title: Overall Study
Started 11 10
Completed 9 10
Not Completed 2 0
Reason Not Completed
Adverse Event             2             0
Arm/Group Title Eleutherococcus Senticosus Placebo Total
Hide Arm/Group Description Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial Fructus Ziziphi Jujube concentrated juice15ml/vial Total of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
64  (13.1) 55.8  (11.3) 60.1  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
5
  45.5%
6
  60.0%
11
  52.4%
Male
6
  54.5%
4
  40.0%
10
  47.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 11 participants 10 participants 21 participants
11 10 21
1.Primary Outcome
Title Erythropoietin (EPO)
Hide Description value at 3 months minus value at baseline reported
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eleutherococcus Senticosus Placebo
Hide Arm/Group Description:
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
Fructus Ziziphi Jujube concentrated juice15ml/vial
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: u/mth
-6000.0  (5916.5) -1714.3  (6264.1)
2.Primary Outcome
Title Hemoglobin (Hb)
Hide Description value at 3 months minus value at baseline reported
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eleutherococcus Senticosus Placebo
Hide Arm/Group Description:
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
Fructus Ziziphi Jujube concentrated juice15ml/vial
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: gm/dl
1.0  (1.1) -0.1  (0.8)
3.Secondary Outcome
Title Red Blood Cell (RBC)
Hide Description value at 3 months minus value at baseline reported
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eleutherococcus Senticosus Placebo
Hide Arm/Group Description:
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
Fructus Ziziphi Jujube concentrated juice15ml/vial
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: 10^4 cells/ul
25.1  (35.6) -7.8  (28.7)
4.Secondary Outcome
Title Hematocrit (Hct)
Hide Description value at 3 months minus value at baseline reported
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eleutherococcus Senticosus Placebo
Hide Arm/Group Description:
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
Fructus Ziziphi Jujube concentrated juice15ml/vial
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: vol% RBC in blood
2.5  (3.2) -0.3  (2.6)
5.Secondary Outcome
Title Mean Corpuscular Hemoglobin Concentration (MCHC)
Hide Description value at 3 months minus value at baseline reported
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eleutherococcus Senticosus Placebo
Hide Arm/Group Description:
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
Fructus Ziziphi Jujube concentrated juice15ml/vial
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: g/dl
-0.5  (0.3) -0.3  (1.0)
6.Secondary Outcome
Title Mean Corpuscular Volume (MCV)
Hide Description value at 3 months minus value at baseline reported
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eleutherococcus Senticosus Placebo
Hide Arm/Group Description:
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
Fructus Ziziphi Jujube concentrated juice15ml/vial
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: fl
1.3  (3.0) 1.7  (2.2)
7.Secondary Outcome
Title Mean Corpuscular Hemoglobin (MCH)
Hide Description value at 3 months minus value at baseline reported
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eleutherococcus Senticosus Placebo
Hide Arm/Group Description:
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
Fructus Ziziphi Jujube concentrated juice15ml/vial
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: Pg
0.0  (1.1) 0.3  (0.7)
8.Secondary Outcome
Title Intact Parathyroid Hormone (iPTH)
Hide Description value at 3 months minus value at baseline reported
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eleutherococcus Senticosus Placebo
Hide Arm/Group Description:
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
Fructus Ziziphi Jujube concentrated juice15ml/vial
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: pg/ml
28.6  (240.5) -97.9  (149.3)
9.Secondary Outcome
Title Tumor Necrosis Factor - Alpha (TNF-alpha)
Hide Description value at 3 months minus value at baseline reported
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eleutherococcus Senticosus Placebo
Hide Arm/Group Description:
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
Fructus Ziziphi Jujube concentrated juice15ml/vial
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: pg/ml
-17.2  (16.1) -14.9  (19.6)
10.Secondary Outcome
Title Interleukin 6 (IL-6)
Hide Description value at 3 months minus value at baseline reported
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eleutherococcus Senticosus Placebo
Hide Arm/Group Description:
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
Fructus Ziziphi Jujube concentrated juice15ml/vial
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: pg/ml
-20.3  (28.7) -0.7  (41.2)
Time Frame 1 and 3 months
Adverse Event Reporting Description Vital signs and patients' self-evaluation of their tolerance and physical improvement was assessed by a structured patient questionnaire administered at months 1 and 3
 
Arm/Group Title Eleutherococcus Senticosus Placebo
Hide Arm/Group Description Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial Fructus Ziziphi Jujube concentrated juice15ml/vial
All-Cause Mortality
Eleutherococcus Senticosus Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
Eleutherococcus Senticosus Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eleutherococcus Senticosus Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/11 (18.18%)      0/10 (0.00%)    
Gastrointestinal disorders     
Subjects complained uncomfortable *  2/11 (18.18%)  2 0/10 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nae-Cherng Yang
Organization: Department of Nutrition, Chung Shan Medical University
Phone: 886-0936810214
EMail: naeman@csmu.edu.tw
Layout table for additonal information
Responsible Party: Nae-Cherng Yang, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT03210519    
Other Study ID Numbers: CS15036
First Submitted: July 3, 2017
First Posted: July 7, 2017
Results First Submitted: April 13, 2020
Results First Posted: May 6, 2020
Last Update Posted: September 16, 2020