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

Chung Shan Medical University

Status: Completed

Conditions: Renal Dialysis

Treatments: Other: Placebo; Dietary Supplement: Eleutherococcus senticosus

Study type: Interventional

Funder types: Other

Identifiers

NCT03210519

CS15036

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Eleutherococcus senticosus

Experimental group

Description:

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

Treatment:

Dietary Supplement: Eleutherococcus senticosus

Placebo

Placebo Comparator group

Description:

Fructus Ziziphi Jujube concentrated juice15ml/vial

Treatment:

Other: Placebo