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

• Sponsor: Chung Shan Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03210519
• Collaborator: (none)
• Enrollment: 21
• Arms: 2
• Actual Duration (Months): 18.7

Study Details

Study Description

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:

1. 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Dialysis	Dietary Supplement: Eleutherococcus senticosus; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: Dec 9, 2015
• Actual Primary Completion Date: Jun 30, 2017
• Actual Study Completion Date: Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eleutherococcus senticosus Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial	Dietary Supplement: Eleutherococcus senticosus; taken orally once/day for 90 days
Placebo Comparator: Placebo Fructus Ziziphi Jujube concentrated juice15ml/vial	Other: Placebo; taken orally once/day for 90 days

Outcome Measures

Primary Outcome Measures

1. Erythropoietin (EPO) [baseline and 3 months]

   value at 3 months minus value at baseline reported

2. Hemoglobin (Hb) [baseline and 3 months]

   value at 3 months minus value at baseline reported

Secondary Outcome Measures

1. Red Blood Cell (RBC) [baseline and 3 months]

   value at 3 months minus value at baseline reported

2. Hematocrit (Hct) [baseline and 3 months]

   value at 3 months minus value at baseline reported

3. Mean Corpuscular Hemoglobin Concentration (MCHC) [baseline and 3 months]

   value at 3 months minus value at baseline reported

4. Mean Corpuscular Volume (MCV) [baseline and 3 months]

   value at 3 months minus value at baseline reported

5. Mean Corpuscular Hemoglobin (MCH) [baseline and 3 months]

   value at 3 months minus value at baseline reported

6. Intact Parathyroid Hormone (iPTH) [baseline and 3 months]

   value at 3 months minus value at baseline reported

7. Tumor Necrosis Factor - Alpha (TNF-alpha) [baseline and 3 months]

   value at 3 months minus value at baseline reported

8. Interleukin 6 (IL-6) [baseline and 3 months]

   value at 3 months minus value at baseline reported

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Chung Shan Medical University

Investigators

• Principal Investigator: Nae-Cherng Yang, Ph. D., Chun Shan Medical University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 5, 2016

More Information

Publications

None provided.

• Responsible Party: Nae-Cherng Yang, Associate Professor, Chung Shan Medical University
• ClinicalTrials.gov Identifier: NCT03210519
• Other Study ID Numbers: CS15036
• First Posted: Jul 7, 2017
• Last Update Posted: Sep 16, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Eleutherococcus Senticosus	Placebo
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

Baseline Characteristics

Arm/Group Title	Eleutherococcus Senticosus	Placebo	Total
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 Participants	11	10	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (13.1)	55.8 (11.3)	60.1 (12.7)
Sex: Female, Male (Count of Participants)
Female	5 45.5%	6 60%	11 52.4%
Male	6 54.5%	4 40%	10 47.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Taiwan	11 100%	10 100%	21 100%

Outcome Measures

1. Primary Outcome

Title	Erythropoietin (EPO)
Description	value at 3 months minus value at baseline reported
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eleutherococcus Senticosus	Placebo
Arm/Group Description	Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial	Fructus Ziziphi Jujube concentrated juice15ml/vial
Measure Participants	9	10
Mean (Standard Deviation) [u/mth]	-6000.0 (5916.5)	-1714.3 (6264.1)

2. Primary Outcome

Title	Hemoglobin (Hb)
Description	value at 3 months minus value at baseline reported
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eleutherococcus Senticosus	Placebo
Arm/Group Description	Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial	Fructus Ziziphi Jujube concentrated juice15ml/vial
Measure Participants	9	10
Mean (Standard Deviation) [gm/dl]	1.0 (1.1)	-0.1 (0.8)

3. Secondary Outcome

Title	Red Blood Cell (RBC)
Description	value at 3 months minus value at baseline reported
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eleutherococcus Senticosus	Placebo
Arm/Group Description	Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial	Fructus Ziziphi Jujube concentrated juice15ml/vial
Measure Participants	9	10
Mean (Standard Deviation) [10^4 cells/ul]	25.1 (35.6)	-7.8 (28.7)

4. Secondary Outcome

Title	Hematocrit (Hct)
Description	value at 3 months minus value at baseline reported
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eleutherococcus Senticosus	Placebo
Arm/Group Description	Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial	Fructus Ziziphi Jujube concentrated juice15ml/vial
Measure Participants	9	10
Mean (Standard Deviation) [vol% RBC in blood]	2.5 (3.2)	-0.3 (2.6)

5. Secondary Outcome

Title	Mean Corpuscular Hemoglobin Concentration (MCHC)
Description	value at 3 months minus value at baseline reported
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eleutherococcus Senticosus	Placebo
Arm/Group Description	Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial	Fructus Ziziphi Jujube concentrated juice15ml/vial
Measure Participants	9	10
Mean (Standard Deviation) [g/dl]	-0.5 (0.3)	-0.3 (1.0)

6. Secondary Outcome

Title	Mean Corpuscular Volume (MCV)
Description	value at 3 months minus value at baseline reported
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eleutherococcus Senticosus	Placebo
Arm/Group Description	Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial	Fructus Ziziphi Jujube concentrated juice15ml/vial
Measure Participants	9	10
Mean (Standard Deviation) [fl]	1.3 (3.0)	1.7 (2.2)

7. Secondary Outcome

Title	Mean Corpuscular Hemoglobin (MCH)
Description	value at 3 months minus value at baseline reported
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eleutherococcus Senticosus	Placebo
Arm/Group Description	Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial	Fructus Ziziphi Jujube concentrated juice15ml/vial
Measure Participants	9	10
Mean (Standard Deviation) [Pg]	0.0 (1.1)	0.3 (0.7)

8. Secondary Outcome

Title	Intact Parathyroid Hormone (iPTH)
Description	value at 3 months minus value at baseline reported
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eleutherococcus Senticosus	Placebo
Arm/Group Description	Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial	Fructus Ziziphi Jujube concentrated juice15ml/vial
Measure Participants	9	10
Mean (Standard Deviation) [pg/ml]	28.6 (240.5)	-97.9 (149.3)

9. Secondary Outcome

Title	Tumor Necrosis Factor - Alpha (TNF-alpha)
Description	value at 3 months minus value at baseline reported
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eleutherococcus Senticosus	Placebo
Arm/Group Description	Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial	Fructus Ziziphi Jujube concentrated juice15ml/vial
Measure Participants	9	10
Mean (Standard Deviation) [pg/ml]	-17.2 (16.1)	-14.9 (19.6)

10. Secondary Outcome

Title	Interleukin 6 (IL-6)
Description	value at 3 months minus value at baseline reported
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eleutherococcus Senticosus	Placebo
Arm/Group Description	Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial	Fructus Ziziphi Jujube concentrated juice15ml/vial
Measure Participants	9	10
Mean (Standard Deviation) [pg/ml]	-20.3 (28.7)	-0.7 (41.2)

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/10 (0%)
Serious Adverse Events
	Eleutherococcus Senticosus		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Eleutherococcus Senticosus		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/11 (18.2%)		0/10 (0%)
Gastrointestinal disorders
Subjects complained uncomfortable	2/11 (18.2%)	2	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

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.