Clinical trial NCT03210519: To Evaluate the Efficacy of Eleutherococcus Senticosus for Subjects Under Renal Dialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Dialysis
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Erythropoietin (EPO)
timeFrame: baseline and 3 months
measure: Hemoglobin (Hb)
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Red Blood Cell (RBC)
timeFrame: baseline and 3 months
measure: Hematocrit (Hct)
timeFrame: baseline and 3 months
measure: Mean Corpuscular Hemoglobin Concentration (MCHC)
timeFrame: baseline and 3 months
measure: Mean Corpuscular Volume (MCV)
timeFrame: baseline and 3 months
measure: Mean Corpuscular Hemoglobin (MCH)
timeFrame: baseline and 3 months
measure: Intact Parathyroid Hormone (iPTH)
timeFrame: baseline and 3 months
measure: Tumor Necrosis Factor - Alpha (TNF-alpha)
timeFrame: baseline and 3 months
measure: Interleukin 6 (IL-6)
timeFrame: baseline and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Chun Shan Medical University
name: Nae-Cherng Yang, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: