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

Study Overview
=================
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: 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.

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

Conditions
-----------------
Renal Dialysis

Intervention / Treatment
-----------------
* Dietary Supplement: Eleutherococcus senticosus
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythropoietin (EPO) | value at 3 months minus value at baseline reported | baseline and 3 months | 
| Hemoglobin (Hb) | value at 3 months minus value at baseline reported | baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red Blood Cell (RBC) | value at 3 months minus value at baseline reported | baseline and 3 months | 
| Hematocrit (Hct) | value at 3 months minus value at baseline reported | baseline and 3 months | 
| Mean Corpuscular Hemoglobin Concentration (MCHC) | value at 3 months minus value at baseline reported | baseline and 3 months | 
| Mean Corpuscular Volume (MCV) | value at 3 months minus value at baseline reported | baseline and 3 months | 
| Mean Corpuscular Hemoglobin (MCH) | value at 3 months minus value at baseline reported | baseline and 3 months | 
| Intact Parathyroid Hormone (iPTH) | value at 3 months minus value at baseline reported | baseline and 3 months | 
| Tumor Necrosis Factor - Alpha (TNF-alpha) | value at 3 months minus value at baseline reported | baseline and 3 months | 
| Interleukin 6 (IL-6) | value at 3 months minus value at baseline reported | baseline and 3 months |