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

• Eleutherococcus senticosus (Dietary supplement): taken orally once/day for 90 days
• Placebo (Other): taken orally once/day for 90 days

Primary outcomes

• Erythropoietin (EPO) [baseline and 3 months]: value at 3 months minus value at baseline reported
• Hemoglobin (Hb) [baseline and 3 months]: value at 3 months minus value at baseline reported

Secondary outcomes

• Red Blood Cell (RBC) [baseline and 3 months]: value at 3 months minus value at baseline reported
• Hematocrit (Hct) [baseline and 3 months]: value at 3 months minus value at baseline reported
• Mean Corpuscular Hemoglobin Concentration (MCHC) [baseline and 3 months]: value at 3 months minus value at baseline reported
• Mean Corpuscular Volume (MCV) [baseline and 3 months]: value at 3 months minus value at baseline reported
• Mean Corpuscular Hemoglobin (MCH) [baseline and 3 months]: value at 3 months minus value at baseline reported
• Intact Parathyroid Hormone (iPTH) [baseline and 3 months]: value at 3 months minus value at baseline reported
• Tumor Necrosis Factor - Alpha (TNF-alpha) [baseline and 3 months]: value at 3 months minus value at baseline reported
• Interleukin 6 (IL-6) [baseline and 3 months]: value at 3 months minus value at baseline reported

Sex: All, ages: 20 Years to 80 Years

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

Participant flow

Outcome results

• Erythropoietin (EPO) (Primary), Mean, u/mth: Eleutherococcus Senticosus -6000.0 +/- 5916.5; Placebo -1714.3 +/- 6264.1
• Hemoglobin (Hb) (Primary), Mean, gm/dl: Eleutherococcus Senticosus 1.0 +/- 1.1; Placebo -0.1 +/- 0.8
• Red Blood Cell (RBC) (Secondary), Mean, 10^4 cells/ul: Eleutherococcus Senticosus 25.1 +/- 35.6; Placebo -7.8 +/- 28.7
• Hematocrit (Hct) (Secondary), Mean, vol% RBC in blood: Eleutherococcus Senticosus 2.5 +/- 3.2; Placebo -0.3 +/- 2.6
• Mean Corpuscular Hemoglobin Concentration (MCHC) (Secondary), Mean, g/dl: Eleutherococcus Senticosus -0.5 +/- 0.3; Placebo -0.3 +/- 1.0
• Mean Corpuscular Volume (MCV) (Secondary), Mean, fl: Eleutherococcus Senticosus 1.3 +/- 3.0; Placebo 1.7 +/- 2.2
• Mean Corpuscular Hemoglobin (MCH) (Secondary), Mean, Pg: Eleutherococcus Senticosus 0.0 +/- 1.1; Placebo 0.3 +/- 0.7
• Intact Parathyroid Hormone (iPTH) (Secondary), Mean, pg/ml: Eleutherococcus Senticosus 28.6 +/- 240.5; Placebo -97.9 +/- 149.3
• Tumor Necrosis Factor - Alpha (TNF-alpha) (Secondary), Mean, pg/ml: Eleutherococcus Senticosus -17.2 +/- 16.1; Placebo -14.9 +/- 19.6
• Interleukin 6 (IL-6) (Secondary), Mean, pg/ml: Eleutherococcus Senticosus -20.3 +/- 28.7; Placebo -0.7 +/- 41.2

Adverse events

Time frame: 1 and 3 months

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2016-06-05)

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