To Evaluate the Efficacy of Eleutherococcus Senticosus for Subjects Under Renal Dialysis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for To Evaluate the Efficacy of Eleutherococcus Senticosus for Subjects Under Renal Dialysis (NCT03210519), a randomized na study. The primary outcome is Erythropoietin (EPO).

2. Clinical Question

The trial was designed to evaluate anti-inflammation and improvement of erythropoietin hyporesponsiveness in people undergoing renal dialysis. Its primary outcome was the change in EPO value from baseline to 3 months. The posted summaries report a mean change for each group, but do not report a formal between-group estimate, confidence interval, or p-value. The record therefore describes the group-level changes without establishing the precision of the difference between them.

The registry also names measures of blood-cell characteristics, parathyroid hormone, and inflammatory markers as secondary outcomes. Those measures provide context for the study’s stated aims, but their results are not included in the posted outcome summaries described in the record. The question addressed by the available numerical results is consequently narrower than the full set of outcomes named in the study description.

3. Trial Design

This was a randomized, double-blind, placebo-controlled, parallel comparison trial. The registry record lists the study status as COMPLETED and the phase as NA. The sponsor was Chung Shan Medical University. The recorded start date was 2015-12-09, and the primary completion date was 2017-06-30.

The brief summary describes a 2-4 weeks run-in period followed by oral study products for 90 days. The active product is described as Acanthopanax senticosus (30mg/vial); the arm description also names a concentrated jujube juice. The placebo description names the same juice without the Acanthopanax senticosus formula. The registry record identifies the interventions as Eleutherococcus senticosus and Placebo.

Enrollment is listed as 21. For the primary outcome summaries, the reported arm sizes are n=9.0 for Eleutherococcus Senticosus and n=10.0 for Placebo. The safety summaries use at-risk counts of 11 for Eleutherococcus Senticosus and 10 for Placebo. These different counts are reported for different summaries; the registry record does not explain the difference or specify the analysis populations.

The randomization method, allocation concealment procedure, and details of how masking was maintained are not reported in the registry record. The record also does not report the protocol’s sample-size justification or whether any interim analyses were planned or conducted.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Erythropoietin (EPO), measured over baseline and 3 months.

The primary endpoint is erythropoietin (EPO), with the unit recorded as u/mth. The registry describes the reported value as the value at 3 months minus the value at baseline. The summaries are means with standard deviations, so each arm’s mean represents its average reported change, while its standard deviation describes variation among the individual changes within that arm.

The trial’s official title frames EPO as relevant to erythropoietin hyporesponsiveness, and the study description identifies improvement of that condition as an aim. In this record, EPO is therefore the measure used to assess that aim. The registry does not give further detail about dose adjustment, how the measure was obtained, or what magnitude of change would be considered important.

A negative mean change indicates that the recorded EPO value at 3 months was lower on average than at baseline for that arm. The arm summaries alone do not show whether the observed changes differ reliably between groups. Such an interpretation requires a between-group estimate and its uncertainty, neither of which is reported for this continuous outcome.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the reported mean describe?

The endpoint is a continuous measure, and the registry reports a mean change for each arm. A mean is a measure of the central value of the observed changes. Because the change is defined as the 3-month value minus the baseline value, a negative mean describes a lower average follow-up value. It does not mean that every participant had a decrease: individual results may vary around the mean.

The reported standard deviation describes the spread of participant-level changes around the arm mean. It is useful for understanding variability, but it is not a measure of how certain the trial’s treatment comparison is. Uncertainty in a mean or a difference between means is usually communicated with a confidence interval or a model-based standard error. Neither a confidence interval nor a standard error for the treatment contrast is reported in the registry record.

Why is the comparison between arms central?

Randomization is intended to make the groups comparable, on average, so that a between-group contrast can assess differences associated with assignment to the study products. Comparing each group’s change with its own baseline is not equivalent to estimating the randomized contrast. Changes may occur in both arms over time, and the relevant trial question is whether the changes differ between the randomized groups.

The posted results give the two arm means and standard deviations, but the registry marks the continuous two-arm comparison as missing or not estimable. No formal comparison result is posted. The arm summaries can be described as observed, but they do not provide the precision or statistical evidence for the contrast. No recalculated comparison is available for interpretation from the registry record.

How should uncertainty be understood?

In general, a confidence interval gives a range of values compatible with the data and the statistical model at a stated confidence level. A narrow interval indicates greater precision than a wide interval, while an interval spanning values on both sides of no difference can indicate uncertainty about the direction of a contrast. These general principles do not supply an interval for this trial: the registry record does not report one for the primary comparison.

A p-value, when reported, evaluates how compatible the observed data are with a specified null model. It does not measure the size or clinical importance of an effect. No p-value for the primary comparison is reported, so the posted data do not permit a significance assessment. Statistical significance and clinical importance are also different questions; the registry does not state a threshold for an important EPO change.

What do the planning illustrations represent?

Any sample-size figures associated with this result are planning illustrations, not observed power. The stated assumptions are a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The planning calculation uses the observed effect and considers the effect to detect as a stated fraction of that observed effect.

These assumptions describe a hypothetical future design calculation. They do not show that the completed trial had a particular probability of detecting an effect, and they are not evidence that the study was adequately powered. A calculation based on an observed effect can be sensitive to the estimate used, particularly when an estimate comes from a small study. The protocol’s original sample-size justification is not reported in the registry record.

Why does over-dispersion matter in general?

For continuous outcomes, variability is represented directly by the distribution of the measurements and, in these summaries, by the standard deviation. In other settings, such as counts, over-dispersion means that variation is greater than a chosen model expects. Ignoring it can make uncertainty estimates too small. That general issue does not establish that over-dispersion affected this trial’s continuous EPO endpoint; the registry record does not describe a model or variance assessment for the comparison.

The listed values should therefore be interpreted as descriptive arm summaries. The missing formal contrast, uncertainty interval, and analysis details limit what can be inferred beyond the observed mean changes.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Eleutherococcus Senticosus", "Placebo")
n   <- c(9, 10)
m   <- c(-6000, -1714.3)
sp  <- c(5916.5, 6264.1)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Eleutherococcus Senticosus  9  -6000.000  5916.500  -10547.824  -1452.176
CARM  Placebo  10  -1714.300  6264.100  -6195.367  2766.767

11. Multiplicity, Missing Data and Analysis Populations

The registry names the primary EPO outcome and eight secondary outcomes: Red Blood Cell (RBC), Hematocrit (Hct), Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Intact Parathyroid Hormone (iPTH), Tumor Necrosis Factor - Alpha (TNF-alpha), and Interleukin 6 (IL-6). Results for these secondary measures are not reported in the registry record.

When a study evaluates multiple outcomes or multiple comparisons, the chance of obtaining at least one apparently unusual result can increase. Statistical approaches can address multiplicity, but the method depends on the planned questions and analysis strategy. Any multiplicity adjustment or hierarchy among outcomes is not reported in the registry record. The record lists 0 analyses, so there is no posted analysis output to assess for these outcomes.

The endpoint summaries and safety summaries have different reported at-risk counts. For EPO, the arm summaries report n=9.0 and n=10.0; for safety, the corresponding at-risk counts are 11 and 10. Enrollment is listed as 21. The record does not describe the analysis populations, reasons for differences in denominators, participant flow, or missing-data handling. It does not state whether an intention-to-treat, per-protocol, or other population was used.

Imputation procedures, sensitivity analyses, and assumptions about missing observations are not reported in the registry record. Without this information, the potential influence of missing outcome data cannot be assessed from the posted summaries. The absence of reported secondary results also means the full set of outcomes named in the record cannot be evaluated for selective availability or multiplicity.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse events for participants at risk in each arm. In the Eleutherococcus Senticosus group, 0 serious adverse events were reported among 11 at risk; in the Placebo group, 0 were reported among 10 at risk. No serious adverse event terms are listed. Deaths are reported as 0 in each group.

For other adverse events, the registry reports 2 affected among 11 at risk in the Eleutherococcus Senticosus group and 0 affected among 10 at risk in the Placebo group. These are the registry’s reported counts; the record does not provide event descriptions, severity, timing, attribution, or a formal comparison between groups.

Zero reported serious events does not establish that the risk is absent. Safety counts are descriptive, and the limited number of participants and lack of detail constrain interpretation. The record does not report whether adverse events were collected using a particular schedule or whether all participants completed safety follow-up.

13. What the Result Does, and Does Not, Mean

The posted primary outcome summaries describe mean EPO decreases from baseline to 3 months in both randomized groups. The mean change was -6000.0 u/mth for Eleutherococcus Senticosus and -1714.0 u/mth for Placebo. These summaries do not, on their own, establish whether the groups differed beyond sampling variability. The record does not report the formal between-group comparison, its confidence interval, or its p-value.

This distinction matters because a difference between two observed means is not automatically a precise or reliable estimate of a treatment contrast. The standard deviations indicate variation in individual changes, but they do not supply the missing uncertainty estimate. The record also does not state what change in EPO would be important for the study’s stated aim.

The trial description names anti-inflammation and improvement of erythropoietin hyporesponsiveness as aims, and it identifies several secondary outcomes relevant to those aims. The registry does not report results for the listed secondary outcomes. Consequently, the posted outcome summaries do not provide a complete evaluation of the full set of questions described in the trial record.

The safety summary records no serious adverse events or deaths in either group, and reports other adverse events in the active arm but not the placebo arm. Those counts are descriptive, with no event detail or comparative analysis. They should not be read as establishing either the presence or absence of a safety difference.

Overall, the record offers limited descriptive evidence from a randomized study but does not provide enough statistical detail to determine the precision of the primary comparison or to assess the named secondary outcomes. This is a statement about what the registry reports, not a recommendation about treatment or an assessment of individual care.

14. Why This Trial Matters Statistically

This trial is statistically instructive because randomization and double masking do not remove the need to report a clear between-group estimate. The clinical question concerns whether outcomes differ by randomized assignment, while the posted primary results are arm-specific mean changes. Without a direct contrast and its uncertainty, readers cannot judge how compatible the observed data are with a range of possible group differences.

The endpoint also highlights the importance of defining change clearly. The registry specifies 3-month value minus baseline value, making the negative arm means interpretable as decreases in recorded EPO values. Yet within-group direction is not the same as evidence for a treatment effect. The control group’s change is essential to the randomized comparison.

Reporting denominators by outcome is another important statistical practice. The record gives different at-risk counts for safety and endpoint summaries, but does not explain the analysis populations or missing data. Transparent participant flow and missing-data methods would help readers understand who contributed to each result and how incomplete observations were handled.

Finally, the registry lists multiple secondary outcomes, but does not post their results or describe multiplicity handling. When a study has several outcomes, readers need the planned analysis strategy and complete reporting to distinguish confirmatory questions from exploratory ones. The available record illustrates how incomplete comparative and outcome reporting can constrain interpretation even when a study has a randomized design.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation for statistical interpretation is that the registry does not report a formal between-group analysis for the continuous primary endpoint. Although arm means and standard deviations are posted, no confidence interval or p-value for the treatment contrast is available. The record indicates that a two-arm comparison was missing or not estimable.

The primary endpoint summaries include n=9.0 and n=10.0, while the safety summaries report 11 and 10 at risk. Enrollment is listed as 21, but the registry does not explain participant flow or the differing denominators. Reasons for missing or unavailable endpoint values are not reported, nor are the missing-data assumptions or sensitivity analyses.

The registry does not state the original sample-size justification, a clinically important difference for EPO, the randomization procedure, or the method used to preserve masking. It also does not describe an analysis model or its assumptions. These omissions prevent assessment of whether the analysis followed a prespecified plan.

Although eight secondary outcomes are named, their results are not reported in the registry record. The record does not describe a multiplicity strategy or identify which outcomes were intended as confirmatory. Safety information is also limited to counts: event descriptions, timing, severity, and attribution are not reported.

These limitations concern the available record and should not be taken as proof that unreported procedures or analyses did not occur. They do mean that readers cannot assess those aspects from the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: To Evaluate the Efficacy of Eleutherococcus Senticosus for Subjects Under Renal Dialysis — NCT03210519.
• Registry record last updated 2020-09-16; status last verified 2020-09.
• Results first posted 2020-05-06.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT03210519 is a completed randomized, double-blind, placebo-controlled, parallel trial of oral Eleutherococcus senticosus in people undergoing renal dialysis. The study description reports a 2-4 weeks run-in and 90 days of study product use. Enrollment is listed as 21.

The primary endpoint was EPO change from baseline to 3 months. The mean changes were -6000.0 u/mth in the Eleutherococcus Senticosus arm and -1714.0 u/mth in the Placebo arm. A formal two-arm comparison and its uncertainty are not reported. The registry also lists eight secondary outcomes, but their results are not reported in the registry record.

The safety summaries report 0 serious adverse events and 0 deaths in each group. Other adverse events are reported as 2 among 11 at risk in the Eleutherococcus Senticosus group and 0 among 10 at risk in the Placebo group. Further analysis-population, missing-data, and safety-event details are not reported in the registry record.