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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eleutherococcus senticosus | Experimental | Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial |
|
| Placebo | Placebo Comparator | Fructus Ziziphi Jujube concentrated juice15ml/vial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eleutherococcus senticosus | Dietary Supplement | taken orally once/day for 90 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nae-Cherng Yang, Ph. D. | Chun Shan Medical University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eleutherococcus Senticosus | Participants first received screening tests for up to 30 days. Eligible subjects were then given the investigational products (Acanthopanax senticosus-mono formula 30mg/vial and Fructus Ziziphi Jujube concentrated juice15ml/vial) to be taken orally once/day for 90 days. Patients with hyperacidity and gastroesophageal reflux were recommended to take it after meals. |
| FG001 | Placebo | Participants first received screening tests for up to 30 days. Eligible subjects were then given the investigational products (Fructus Ziziphi Jujube concentrated juice15ml/vial) to be taken orally once/day for 90 days. Patients with hyperacidity and gastroesophageal reflux were recommended to take it after meals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eleutherococcus Senticosus | Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial |
| BG001 | Placebo | Fructus Ziziphi Jujube concentrated juice15ml/vial |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Erythropoietin (EPO) | value at 3 months minus value at baseline reported | Posted | Mean | Standard Deviation | u/mth | baseline and 3 months |
|
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1 and 3 months
Vital signs and patients' self-evaluation of their tolerance and physical improvement was assessed by a structured patient questionnaire administered at months 1 and 3
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eleutherococcus Senticosus | Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subjects complained uncomfortable | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nae-Cherng Yang | Department of Nutrition, Chung Shan Medical University | 886-0936810214 | naeman@csmu.edu.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2016 | Mar 4, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000713177 | Siberian ginseng root |
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| Placebo | Other | taken orally once/day for 90 days |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
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| Primary | Hemoglobin (Hb) | value at 3 months minus value at baseline reported | Posted | Mean | Standard Deviation | gm/dl | baseline and 3 months |
|
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| Secondary | Red Blood Cell (RBC) | value at 3 months minus value at baseline reported | Posted | Mean | Standard Deviation | 10^4 cells/ul | baseline and 3 months |
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| Secondary | Hematocrit (Hct) | value at 3 months minus value at baseline reported | Posted | Mean | Standard Deviation | vol% RBC in blood | baseline and 3 months |
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| Secondary | Mean Corpuscular Hemoglobin Concentration (MCHC) | value at 3 months minus value at baseline reported | Posted | Mean | Standard Deviation | g/dl | baseline and 3 months |
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| Secondary | Mean Corpuscular Volume (MCV) | value at 3 months minus value at baseline reported | Posted | Mean | Standard Deviation | fl | baseline and 3 months |
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| Secondary | Mean Corpuscular Hemoglobin (MCH) | value at 3 months minus value at baseline reported | Posted | Mean | Standard Deviation | Pg | baseline and 3 months |
|
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| Secondary | Intact Parathyroid Hormone (iPTH) | value at 3 months minus value at baseline reported | Posted | Mean | Standard Deviation | pg/ml | baseline and 3 months |
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| Secondary | Tumor Necrosis Factor - Alpha (TNF-alpha) | value at 3 months minus value at baseline reported | Posted | Mean | Standard Deviation | pg/ml | baseline and 3 months |
|
|
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| Secondary | Interleukin 6 (IL-6) | value at 3 months minus value at baseline reported | Posted | Mean | Standard Deviation | pg/ml | baseline and 3 months |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 2 |
| 11 |
| EG001 | Placebo | Fructus Ziziphi Jujube concentrated juice15ml/vial | 0 | 10 | 0 | 10 | 0 | 10 |
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