Renal DialysisNCT03210519
To Evaluate the Efficacy of Eleutherococcus Senticosus for Subjects Under Renal Dialysis
A study testing Eleutherococcus senticosus in people with Renal Dialysis, run by Chung Shan Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- Eleutherococcus senticosus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2015to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Under regular dialysis for at least 3 months
- Hemoglobin (Hb) <11 g/L after regular Erythropoietin (EPO) treatment
- Subjects with written informed consent form
Who cannot join
- 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%)
Show all 13Show fewer
- 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
About this study
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
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.
- Conditions
- Renal Dialysis
- Being tested
- Eleutherococcus senticosus, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eleutherococcus senticosusDietary supplement
taken orally once/day for 90 days
PlaceboOther
taken orally once/day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Eleutherococcus senticosus | Experimental | Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial Receives: Dietary Supplement: Eleutherococcus senticosus |
| Placebo | Placebo comparator | Fructus Ziziphi Jujube concentrated juice15ml/vial Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythropoietin (EPO)
value at 3 months minus value at baseline reported
Measured: baseline and 3 months
Hemoglobin (Hb)
value at 3 months minus value at baseline reported
Measured: baseline and 3 months
Secondary outcomes (8)
Red Blood Cell (RBC)
value at 3 months minus value at baseline reported
Measured: baseline and 3 months
Hematocrit (Hct)
value at 3 months minus value at baseline reported
Measured: baseline and 3 months
Mean Corpuscular Hemoglobin Concentration (MCHC)
value at 3 months minus value at baseline reported
Measured: baseline and 3 months
Mean Corpuscular Volume (MCV)
value at 3 months minus value at baseline reported
Measured: baseline and 3 months
Mean Corpuscular Hemoglobin (MCH)
value at 3 months minus value at baseline reported
Measured: baseline and 3 months
Intact Parathyroid Hormone (iPTH)
value at 3 months minus value at baseline reported
Measured: baseline and 3 months
Tumor Necrosis Factor - Alpha (TNF-alpha)
value at 3 months minus value at baseline reported
Measured: baseline and 3 months
Interleukin 6 (IL-6)
value at 3 months minus value at baseline reported
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start9 Dec 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nae-Cherng Yang, Chung Shan Medical University
- Investigators
- Nae-Cherng Yang, Ph. D., Principal investigator, Chun Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210519
- Sponsor's protocol ID
- CS15036
- Status last verified
- Sep 2020
- First submitted
- 3 Jul 2017
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03210519
- Acronym / sponsor ID
- CS15036
- Conditions
- Renal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 9 Dec 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Posted 6 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eleutherococcus senticosus | Experimental | Dietary Supplement: Eleutherococcus senticosusAcanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial |
| Placebo | Placebo comparator | Other: PlaceboFructus Ziziphi Jujube concentrated juice15ml/vial |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Under regular dialysis for at least 3 months
- Hemoglobin (Hb) <11 g/L after regular Erythropoietin (EPO) treatment
- Subjects with written informed consent form
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eleutherococcus senticosustaken orally once/day for 90 days | Dietary supplement | Eleutherococcus senticosus |
| Placebotaken orally once/day for 90 days | Other | Placebo |
Primary outcome
Erythropoietin (EPO)
Time frame: baseline and 3 months
value at 3 months minus value at baseline reported
Hemoglobin (Hb)
Time frame: baseline and 3 months
value at 3 months minus value at baseline reported
8 secondary outcomes
Red Blood Cell (RBC)
Time frame: baseline and 3 months
Hematocrit (Hct)
Time frame: baseline and 3 months
Mean Corpuscular Hemoglobin Concentration (MCHC)
Time frame: baseline and 3 months
Mean Corpuscular Volume (MCV)
Time frame: baseline and 3 months
Mean Corpuscular Hemoglobin (MCH)
Time frame: baseline and 3 months
Intact Parathyroid Hormone (iPTH)
Time frame: baseline and 3 months
Tumor Necrosis Factor - Alpha (TNF-alpha)
Time frame: baseline and 3 months
Interleukin 6 (IL-6)
Time frame: baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nae-Cherng Yang, Ph. D. principal investigator
Chun Shan Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Eleutherococcus senticosus in people with Renal Dialysis, run by Chung Shan Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythropoietin (EPO) (time frame: baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.