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

Renal Dialysis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03210519
• Other study ID #: CS15036
• Status: Completed
• Phase: N/A
• Start date: December 9, 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: September 2020
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Dialysis

Intervention

Dietary Supplement:
• Eleutherococcus senticosus
taken orally once/day for 90 days

Other:
• Placebo
taken orally once/day for 90 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythropoietin (EPO)	value at 3 months minus value at baseline reported	baseline and 3 months
Primary	Hemoglobin (Hb)	value at 3 months minus value at baseline reported	baseline and 3 months
Secondary	Red Blood Cell (RBC)	value at 3 months minus value at baseline reported	baseline and 3 months
Secondary	Hematocrit (Hct)	value at 3 months minus value at baseline reported	baseline and 3 months
Secondary	Mean Corpuscular Hemoglobin Concentration (MCHC)	value at 3 months minus value at baseline reported	baseline and 3 months
Secondary	Mean Corpuscular Volume (MCV)	value at 3 months minus value at baseline reported	baseline and 3 months
Secondary	Mean Corpuscular Hemoglobin (MCH)	value at 3 months minus value at baseline reported	baseline and 3 months
Secondary	Intact Parathyroid Hormone (iPTH)	value at 3 months minus value at baseline reported	baseline and 3 months
Secondary	Tumor Necrosis Factor - Alpha (TNF-alpha)	value at 3 months minus value at baseline reported	baseline and 3 months
Secondary	Interleukin 6 (IL-6)	value at 3 months minus value at baseline reported	baseline and 3 months