This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis (NCT02331589), a randomized phase 4 study. The primary outcome is Liver Enzymes.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02331589 |
| Phase | Phase 4 |
| Condition | Fatigue |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 75 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Chuncheon Sacred Heart Hospital |
| Results posted | Yes |
2. Clinical Question
Population
Patients with non-alcoholic hepatitis. The registry record gives an enrollment of 75 and identifies fatigue as a condition. It does not report detailed eligibility criteria or describe the characteristics of participants at baseline.
Intervention
Korean Red Ginseng (KRG), described as a capsule taken at 3,000 mg/day for 3 weeks. The registry record says participants were prospectively randomized to KRG or placebo.
Comparator
Placebo for KRG, administered for 3 weeks. The placebo description does not give further information about its composition or administration.
Primary question
The primary outcome is liver enzymes measured after 3 weeks of KRG. The listed measures are aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and lactate dehydrogenase. The registry record does not report their results or a statistical comparison between the groups.
In statistical terms, the trial asks whether the measured liver enzyme outcomes differ between the KRG and placebo groups at the stated follow-up. The record also names fatigue severity, pro-inflammatory cytokine, and adiponectin as secondary outcomes. Its summary says that liver function tests, cytokines, adiponectin, fatigue severity, and antioxidant activity were checked and compared. However, no numerical outcome results or analysis details are reported in the registry record, so the direction, magnitude, and precision of any group differences cannot be described.
3. Trial Design
The registry identifies this as a Phase 4, randomized, single-masked, parallel-group trial. The study status is completed, and the registry lists enrollment as 75. Its summary describes prospective randomization of patients with non-alcoholic hepatitis to KRG or placebo for 3 weeks. The KRG arm is described as receiving a capsule at 3,000 mg/day; the placebo arm is described as receiving placebo for KRG for 3 weeks.
In a parallel-group design, participants are assigned to a study group and outcomes are compared between groups. Randomization is intended, in general, to reduce systematic differences between groups at the start of a trial. The registry record does not describe the sequence-generation method, how assignments were concealed, or the allocation ratio actually used. Although masking is recorded as single, the record does not say which people involved in the trial were masked or how masking was maintained.
The listed primary outcome is liver enzymes at the timeframe described as 3 weeks of KRG. It covers aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and lactate dehydrogenase. The registry lists fatigue measured by KRUPP's Fatigue Severity Scale, pro-inflammatory cytokine, and adiponectin as secondary outcomes. The trial summary also mentions antioxidant activity. Detailed measurement procedures and the timing of each secondary outcome are not reported in the registry record.
The registry gives start and primary-completion dates of 2011-08 and 2012-04. It does not report the number assigned to each group, the number completing follow-up, or the analysis population. Enrollment is a planning or recruitment descriptor in the record; without group-level flow and outcome data, it cannot establish how many participants contributed to any particular analysis.
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
| Stage | Korea Red Ginseng (KRG) | Placebo (for KRG) |
|---|---|---|
| STARTED | 39 | 36 |
| COMPLETED | 34 | 31 |
| NOT COMPLETED | 5 | 5 |
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.
| Characteristic | Unit | Korea Red Ginseng (KRG) | Placebo (for KRG) | Total |
|---|---|---|---|---|
| Participants analysed | 34 | 31 | 65 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 31 | 27 | 58 |
| Age, Categorical: >=65 years | Participants | 3 | 4 | 7 |
| Age, Continuous | years | 45.8 (SD 12.7) | 50.0 (SD 12.8) | 47.8 (SD 12.9) |
| Sex: Female, Male: Female | Participants | 7 | 5 | 12 |
| Sex: Female, Male: Male | Participants | 27 | 26 | 53 |
| Region of Enrollment: Korea, Republic of | participants | 34 | 31 | 65 |
6. Primary Endpoint
The registry lists the primary outcome as Liver Enzymes, measured over 3 weeks of KRG.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | U/L |
| Endpoint classification | Continuous Endpoint |
The primary outcome is titled “Liver Enzymes.” It is described as a mean of a continuous measure, with standard deviation as the stated measure of dispersion. The listed components are aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and lactate dehydrogenase, measured in U/L. The timeframe is 3 weeks of KRG.
Liver enzyme measurements are laboratory indicators used in assessing liver function. As a general statistical matter, continuous measurements can be described by their mean and variability, and a comparison between groups can estimate how their average values differ. The standard deviation describes spread among measurements; it is not the same as the uncertainty in an estimated group mean or group difference.
The registry record does not provide values for any of the listed enzymes, group means, standard deviations, or a definition of how the four enzyme measures were handled as a primary outcome. It also does not report a composite score or identify a single enzyme as the primary measure. Because the primary outcome includes several categories and is not reduced to one comparison in the posted results, no single primary estimate or confidence interval can be interpreted from the registry record.
The stated timeframe identifies when the primary outcome was intended to be assessed, but the record does not provide further details about measurement procedures, baseline values, or changes from baseline. Those omissions limit what can be inferred about the endpoint and its comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of KRG with placebo in patients with non-alcoholic hepatitis and lists liver enzymes as the primary outcome. It does not report numerical results for the primary or secondary outcomes. It also records no statistical analyses. Consequently, there is no posted estimate of a group difference, no measure of its precision, and no reported test result on which to base an interpretation of the outcomes.
Without group-level results, the direction and magnitude of any observed difference are unknown from this record. It is not possible to determine whether the enzyme measurements were higher or lower in either group, how variable they were, or whether the groups differed at follow-up. The same limitation applies to fatigue severity, pro-inflammatory cytokine, and adiponectin. Although the trial summary mentions antioxidant activity, it does not give a result for that measure either.
A confidence interval, in general, expresses the precision of an estimated effect under the assumptions of the analysis. No confidence interval is reported. A p-value would address compatibility of data with a specified statistical model and null hypothesis, but no p-value or analysis model is reported in the registry record. The absence of these statistics is not evidence that the groups were identical, nor does it establish that a difference was present.
The record states an enrollment of 75, but does not provide group-specific numbers, outcome denominators, participant flow, or missing-data information. Enrollment alone cannot establish the amount of information available for an endpoint. The registry also does not report whether analyses adjusted for baseline values or other factors, or whether all randomized participants were included. These details matter when assessing the meaning and reliability of any estimated comparison.
The sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. Such an illustration is not the trial's original design justification and is not observed power. Since the registry record does not report the outcome estimates needed to interpret an observed effect, no numerical planning result can be assessed from the record.
The posted information therefore supports a description of the trial question and design, not a conclusion about the comparative outcomes. Interpretation of the actual effects would require outcome estimates, their uncertainty, and information about the analyses and participants included.
9. Statistical Methods Explained
What does randomization contribute?
Randomization assigns participants to study groups using a chance-based process. In general, this helps limit systematic differences in prognostic characteristics between groups and supports a fair comparison. It does not guarantee that groups will be identical, particularly in a trial with limited enrollment. The registry records randomization but does not report how the assignment sequence was generated, whether assignments were concealed, or how many participants were assigned to each group. Those details are not reported in the registry record.
What does single masking mean?
Masking is intended to reduce the influence of knowing a participant's assigned intervention on conduct, measurement, or reporting. The registry records the trial as single-masked but does not identify who was masked. It also does not describe how the placebo was matched to KRG or whether masking was assessed. The label alone therefore does not establish which sources of bias masking could address in this trial.
How should a mean and standard deviation be read?
The primary outcome is described as a mean of a continuous measure, with standard deviation. A mean gives a summary of the measurements' central location. The standard deviation describes how dispersed individual measurements are around that mean. It does not directly quantify uncertainty in the mean or in a difference between groups. General statistical comparisons may use group means and their standard errors to estimate a difference and its confidence interval, but no means, standard deviations, or comparison estimates are reported in the registry record.
The primary outcome covers several liver enzymes. When several outcomes or comparisons are examined, the chance of seeing an apparently notable result by chance can increase. General methods for addressing this include defining a primary comparison in advance or adjusting interpretation for multiple testing. The registry record does not report how the several enzyme measures were prioritized, combined, or handled statistically. It does not report a multiplicity plan.
What is a confidence interval?
In general, a confidence interval gives a range of values compatible with an estimate under the assumptions of a statistical procedure. Its width reflects precision: less precise estimates generally have wider intervals. A confidence interval does not remove the need to consider bias, measurement quality, or the analysis population. No confidence interval for any outcome is reported in the registry record, so the precision of the trial's estimated effects cannot be evaluated from the posted information.
Why does over-dispersion matter?
As a general concept, over-dispersion occurs when the variability in data is greater than a statistical model assumes. A model that understates variability can produce uncertainty estimates that are too small. This issue is relevant to some types of outcome data, such as counts, but the registry describes the primary outcome as a continuous mean and does not specify an analysis model. There is no basis in the registry record to determine whether over-dispersion was assessed or relevant to any reported analysis.
What do the sample-size assumptions describe?
The record describes a planning illustration using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. In general, a sample-size illustration estimates the group size that would be required under its assumptions; it is not a measure of the probability that this completed trial found a true effect. It is not observed power. The record does not report the original sample-size justification or enough outcome information to interpret a planning calculation based on the observed effect.
What analysis details are missing?
The registry does not report the statistical model, the approach to baseline measurements, the analysis population, handling of missing observations, or whether analyses were adjusted. It records zero analyses. These omissions mean that the analysis strategy and the relationship between the stated design and any outcome estimate cannot be assessed. No recalculated comparison is available from the reported summary statistics, and there is no sponsor analysis in the registry record to compare with a recalculation.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome lists several liver enzyme measures, while the registry also names fatigue severity, pro-inflammatory cytokine, and adiponectin as secondary outcomes. The study summary additionally mentions antioxidant activity. Assessing several outcomes can raise multiplicity concerns: as a general statistical matter, multiple comparisons can increase the chance of a result appearing notable by chance. A prespecified hierarchy, a defined composite, or an adjustment procedure can help guide interpretation. The registry record does not report whether any of these approaches was planned or used, or how the listed enzyme measures were prioritized.
Missing-data handling is not reported in the registry record. There is no account of withdrawals, incomplete outcome measurements, reasons for missingness, or whether any imputation or other method was used. The number analyzed for each outcome is also not reported. These omissions matter because the number and pattern of missing observations can affect both the estimated comparison and its precision.
The analysis population is not reported in the registry record. It is therefore unclear whether the analysis included all randomized participants, only those who completed follow-up, or a different group. The number assigned to each arm and participant flow are not reported either. The record lists zero analyses, so it does not identify a reported primary model or an analysis set.
Without these details, the registry record does not support an assessment of how multiplicity or missing data were addressed, or whether the reported analysis followed a prespecified plan. This is an uncertainty about reporting, not evidence that any particular method was or was not used outside the record.
11. What the Result Does, and Does Not, Mean
The registry record documents a completed, randomized, single-masked, parallel comparison of KRG and placebo for 3 weeks in patients with non-alcoholic hepatitis. It lists liver enzymes as the primary outcome and describes fatigue severity, pro-inflammatory cytokine, and adiponectin as secondary outcomes. The record also says antioxidant activity was checked and compared. These details establish the study question and some elements of its design.
They do not establish the direction or size of any difference between groups. Numerical outcome results are not reported in the registry record, and the record lists zero analyses. There are no reported means, standard deviations, confidence intervals, or p-values from which to assess the outcomes. Accordingly, the record does not show whether the groups differed, how precise a possible difference was, or whether the findings were consistent across the listed measures.
The registry lists zero for the fields describing participants at risk and affected by serious and other adverse events in each group. Because the at-risk fields are also recorded as zero, these entries do not provide usable denominators for interpreting event occurrence. The death fields are not reported. These registry entries therefore cannot establish that no adverse events or deaths occurred.
More generally, a completed trial status does not itself mean that results are present in the registry record. Enrollment does not reveal the numbers analyzed, and a planning illustration does not describe an observed treatment effect. The posted information can be used to characterize the intended comparison, but it cannot support a conclusion about the comparative clinical outcomes or their precision.
12. Why This Trial Matters Statistically
This trial is statistically notable as a registry record in which the design is described but outcome analyses are not reported. The record identifies randomization, masking, parallel groups, the intervention and comparator, and a primary outcome timeframe. These features make the intended comparison understandable. Yet a design description and an outcome estimate answer different questions: the former explains how a study was set up, while the latter is needed to quantify what the posted data show.
The primary outcome is not a single named laboratory measure but a set of liver enzymes. That makes clear outcome specification important. In general, when multiple measures are designated as primary or examined together, readers need to know how comparisons were selected and how multiplicity was addressed. The registry record does not provide those analysis details, nor does it report an estimate for any of the listed enzymes.
The record also illustrates why enrollment and sample-size planning should not be confused with information available for interpreting results. Enrollment is listed as 75, but group-specific enrollment, analysis denominators, and outcome data are absent. The planning assumptions describe an illustration based on an observed effect; such planning is not observed power and cannot substitute for a reported effect estimate with uncertainty.
For biostatistical interpretation, the central limitation is therefore not a particular numerical finding but the absence of reportable analysis results. Without estimates, uncertainty measures, participant flow, and analysis methods, readers cannot evaluate precision, missing-data effects, multiplicity, or consistency among outcomes. The record defines a comparison but does not provide the statistical evidence needed to characterize its result.
13. 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 registry record provides limited detail about trial conduct and analysis. It does not report eligibility criteria beyond describing patients with non-alcoholic hepatitis, baseline characteristics, the randomization method, allocation concealment, or which parties were masked. It gives the overall enrollment as 75 but does not report numbers assigned to each group or participant flow through follow-up.
The primary outcome is described as liver enzymes and includes aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and lactate dehydrogenase. The record does not report values for these measures, define a composite, identify a single measure as the primary comparison, or give an analysis method. It also does not provide results for the listed secondary outcomes. Although antioxidant activity appears in the study summary, no result or detailed outcome description is reported for it.
Statistical analysis details are not reported in the registry record. This includes the model, the analysis population, baseline adjustment, handling of missing data, and any approach to multiplicity. The record lists zero analyses. Consequently, readers cannot check whether the analyses corresponded to the stated outcomes or evaluate the precision of estimates.
Adverse-event reporting is also difficult to interpret: the record lists zero participants at risk and zero affected for serious and other events in both groups, leaving no usable event denominators. Death counts are not reported. These entries should not be read as evidence that events did not occur.
These are limitations of what the registry record reports. They do not establish what analyses or additional data may exist elsewhere, and the registry record does not explain why these details are absent.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis — NCT02331589.
- Registry record last updated 2015-02-10; status last verified 2014-12.
- Results first posted 2015-02-10.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
17. Record Summary
The record describes NCT02331589, a completed Phase 4, randomized, single-masked, parallel trial sponsored by Chuncheon Sacred Heart Hospital. It lists enrollment of 75 and describes prospective randomization of patients with non-alcoholic hepatitis to KRG or placebo for 3 weeks. The KRG capsule dose is 3,000 mg/day.
The primary outcome is liver enzymes in U/L at 3 weeks of KRG, covering aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and lactate dehydrogenase. Secondary outcomes listed are fatigue measured by KRUPP's Fatigue Severity Scale, pro-inflammatory cytokine, and adiponectin. The study summary also mentions antioxidant activity.
Numerical outcome results, statistical analyses, participant flow, and analysis methods are not reported in the registry record. The record therefore describes the trial question and design but does not provide estimates with which to interpret comparative outcomes or their precision.