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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-09

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Eleutherococcus senticosus

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

Group Type EXPERIMENTAL

Eleutherococcus senticosus

Intervention Type DIETARY_SUPPLEMENT

taken orally once/day for 90 days

Placebo

Fructus Ziziphi Jujube concentrated juice15ml/vial

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

taken orally once/day for 90 days

Interventions

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Eleutherococcus senticosus

taken orally once/day for 90 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

taken orally once/day for 90 days

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No