Homeopathic Cold Medicine for Children: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Homeopathic Cold Medicine for Children (NCT00858494), a na na study. The primary outcome is Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy..

2. Clinical Question

3. Trial Design

This completed study, NCT00858494, is titled Homeopathic Cold Medicine for Children and is sponsored by the University of Washington. The registry classifies it as a single-group study, with allocation listed as NA and masking as none. Its enrollment is 50. The condition listed is upper respiratory tract infection. The registry records a start date of 2009-03 and a primary completion date of 2009-10, and lists the study status as completed.

The intervention was Hyland's Cold 'n Cough 4 Kids. There is no like-for-like control arm in the record, and the study is not a randomized comparison. The design can describe the observations recorded after doses in the study group, but does not by itself separate a treatment-related change from the natural course of symptoms, expectations, or other influences. The registry record does not report a comparator group or a masking procedure.

The primary outcome was based on parental reports. For each dose, parents recorded which symptoms were present and rated their change one hour later. Study logs covered up to 6 doses, within a timeframe of up to 10 days from the index visit. A secondary outcome concerned parental reports of an adverse event after a dose of study medication.

The primary outcome description says completed logs were received from 37 of 49 enrolled participants, while the overall enrollment is listed as 50. The registry record does not explain this difference or report why some participants did not contribute completed logs. It also does not report the protocol details, the reason for the planned enrollment, or a statistical analysis plan. The single-group design is central to interpreting the posted results: recorded changes are observations over time, not estimates of a contrast against an untreated or alternative-treatment group.

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.

Before assignment: one participant who was enrolled had a positive test for streptococcal pharyngitis at the index visit and was prescribed antibiotics. This participant thus became ineligible.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Some symptoms were not present at each dose of the homeopathic remedy. Number of doses at which symptom was present: runny nose: 135, nasal congestion: 152, cough: 154, sneezing 81. The outcome is number of times improvement in each symptom was noted.

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 Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy., measured over up to 10 days from index visit.

The primary endpoint counts occasions on which parents reported improvement in a particular symptom after a dose. Parents first indicated which of four symptoms were present—runny nose, cough, nasal congestion, or sneezing—and then rated change one hour after the dose. Responses were grouped as at least some improvement or better, versus no improvement or worse. The outcome is the number of times improvement in a specific symptom was noted, rather than a measure of how severe symptoms were or how much they changed.

This type of measure can describe the pattern of symptom reports following doses. Counting only occasions when a symptom was present makes the number of possible observations different across symptoms. The record lists 135 doses when runny nose was present, 152 for nasal congestion, 154 for cough, and 81 for sneezing. These are numbers of symptom-present doses, not numbers of improved symptoms. The record does not report the improvement counts for any symptom, so those denominators alone cannot show how often improvement was reported.

As a general statistical point, an endpoint should be read in light of what was measured and the observations it includes. Here, the endpoint relies on parental ratings at one hour after a dose, not an independently assessed symptom score. It also does not establish what would have happened over the same period without the remedy. The posted record does not report an efficacy estimate or an analysis of this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the study as single-group, with allocation listed as NA and masking as none. In a single-group design, observations are collected in one group rather than contrasted with outcomes in a concurrently assigned control group. This can be useful for describing what participants or caregivers report, but it does not provide the same basis for attributing a change to an intervention as a randomized comparison. General statistical principle: a comparator helps distinguish changes associated with an intervention from changes that may occur over time or for other reasons.

What does the endpoint count?

The primary endpoint is a count of improvement reports for each symptom. Parents indicated whether a symptom was present at a dose and, if present, rated its change one hour later. The response was dichotomized: at least some improvement or better counted as improvement, while no improvement or worse was the other category. Thus the endpoint counts how many times improvement was noted, not the magnitude of improvement, the duration of relief, or the number of children who improved at least once.

The number of possible observations varies by symptom. The record reports 135 doses at which runny nose was present, 152 for nasal congestion, 154 for cough, and 81 for sneezing. These totals are not interchangeable denominators, and they should not be read as counts of children or as counts of favorable responses. Repeated doses from a participant also mean the observations are not necessarily independent. General statistical principle: repeated measurements from one person can be correlated, so an analysis that treats every recorded dose as independent may understate uncertainty. The registry record does not report whether or how repeated observations were accounted for.

What analysis is reported?

The registry lists 0 analyses. It does not report a statistical model, a summary estimate of improvement, a confidence interval, or a p-value for the primary endpoint. The fact that an endpoint is defined does not mean that an analysis result is posted. The record also does not report whether analyses were planned separately for each symptom, how any multiple comparisons would be handled, or whether an adjusted analysis was intended.

General statistical principle: an estimate describes the observed quantity, while its uncertainty describes how precisely that quantity has been estimated under the analysis assumptions. A confidence interval is one common way to communicate that uncertainty. A p-value, when used, addresses the compatibility of data with a specified null hypothesis under a statistical model; it is not a measure of clinical importance. Neither type of result appears in the registry record for this endpoint, so there is no basis to describe statistical significance or precision.

Why does the design matter?

Without a comparator, a before-and-after or after-dose pattern cannot by itself tell whether the remedy caused a change. Symptoms may change over time, and ratings may be influenced by expectations or by how a caregiver interprets a response. These are general considerations for interpreting an unmasked, single-group symptom study, not claims about what occurred in this study. The record does not report a design feature that would address these alternative explanations.

The outcome is also based on parental report at one hour after each dose. This timing defines the observation being counted, but the registry does not report validation details for the rating approach or an independent assessment. The cutoff between improvement and no improvement or worsening is a binary classification described in the record; the underlying degree of change is not retained in the endpoint as described.

What do planning illustrations mean?

Any sample-size illustrations associated with this page are planning exercises, not results from the trial and not observed power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a fraction of the observed effect. The illustration is therefore a hypothetical two-arm planning framework, unlike this trial’s single-group design. Its assumptions do not establish the trial’s original design rationale or show that the study had a particular probability of detecting an effect. The registry record does not report a sample-size justification or the trial’s own statistical plan.

10. Multiplicity, Missing Data and Analysis Populations

The primary endpoint covers four symptoms: runny nose, cough, nasal congestion, and sneezing. The record describes improvement counts separately by symptom, and the study logs could include up to 6 doses per participant. Considering several symptoms and repeated dose observations creates multiple analytic choices. The registry record does not report whether one symptom was designated as the sole basis for a primary inference, whether results were intended to be combined, or how multiplicity would be addressed. It also reports 0 analyses, so no multiplicity-adjusted or unadjusted efficacy result is available.

Missingness is relevant because completed study logs were received from 37 of 49 enrolled participants. The record does not state why the remaining participants did not have completed logs, whether partially completed logs existed, or how missing observations were handled. It does not report an analysis population definition or a comparison of participants with and without completed logs. As a general statistical matter, missing outcome data can affect interpretation when the likelihood of missingness is related to symptoms or response; the registry record does not provide enough information to assess that possibility.

The overall enrollment is listed as 50, whereas the primary outcome description refers to 49 enrolled participants and the adverse-event table lists 49 at risk for serious events. The record does not explain the difference. It also lists 37 at risk for other adverse events, matching the completed-log count, but does not state why these denominators differ by safety category. No assumption about the reasons for these counts can be made from the registry record.

11. Safety Results

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

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 adverse-event record lists 0 serious adverse events among 49 participants at risk. It lists 2 other adverse events among 37 participants at risk. The record does not list any serious-event terms, and the registry entries do not identify the other events. These entries should be read as counts in the posted safety categories, with their stated denominators.

Zero serious events in the table does not establish that risk is absent. In general, safety counts describe events recorded within the study and depend on how events were collected, classified, and reported. The registry record does not provide further details about event definitions, monitoring procedures, severity classification beyond the listed categories, or the nature of the two other events. Nor does it explain why the risk denominators are 49 and 37 or how they relate to the overall enrollment of 50.

The secondary outcome is described as parental report of an adverse event after a dose of study medication. These safety counts do not establish a comparison with another treatment or with no treatment, because the study is single-group. They should not be combined with the primary symptom-improvement measure, which is a separate outcome.

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

The result that can be read directly from the registry is principally a description of what the study set out to record. Parents were asked to report four symptoms and rate each symptom one hour after a dose. Improvement was defined as at least some improvement or better. The record gives the numbers of doses at which each symptom was present, but does not report how many of those occasions were classified as improved. It therefore does not quantify the primary outcome in the registry record.

The study’s single-group design also limits what any observed change could establish. Without a randomized comparison group, a symptom change after a dose cannot be separated from the ordinary course of an illness, expectations, or other factors. This is a general limitation of interpreting uncontrolled observations, not a claim that any particular factor affected these participants. The registry record does not report an efficacy analysis that could be evaluated for magnitude or precision.

The safety record reports 0 serious adverse events among 49 at risk and 2 other adverse events among 37 at risk. These counts describe the entries in the registry, not a comparative safety estimate, and the other events are not identified in the registry record. They do not establish the absence of unrecorded events or address outcomes outside the reported categories.

In general, a well-interpreted trial result requires clarity about the outcome, the analysis population, missing observations, and uncertainty around estimates. Here, completed logs are reported for 37 of 49 enrolled participants, but reasons for missing logs and methods for handling missing data are not reported in the registry record. The record lists 0 analyses and does not provide an effect estimate, confidence interval, or p-value. Consequently, it is not possible to determine from these entries how large or precise an improvement estimate was, or whether a formal statistical test supported one. This page should be read as an analysis of the registry’s design and reporting, not as a conclusion about whether the remedy is effective or ineffective.

13. Why This Trial Matters Statistically

This study illustrates why a clearly named outcome is not the same as a reported result. The registry defines a concrete observation—whether a parent noticed at least some improvement in a symptom one hour after a dose—and gives the numbers of symptom-present doses. Yet it does not report the corresponding improvement counts or an efficacy analysis. Without those quantities, readers cannot assess the observed frequency of improvement, its uncertainty, or whether patterns differed among symptoms.

It also highlights the statistical importance of design. A single-group study can record changes after an intervention, but it cannot provide a randomized estimate of how those outcomes compare with a control condition. The absence of masking is another design feature readers should keep in mind when interpreting parent-reported symptoms. These features do not invalidate the observations; they define what questions the observations can answer.

The repeated-dose structure matters as well. Each child could contribute reports at multiple doses, and not every symptom was present at every dose. General statistical principle: repeated measures and unequal numbers of symptom-present occasions affect how data should be summarized and analyzed. The registry does not report an analysis that explains how it addressed these features.

Finally, the differing counts—50 enrolled overall, 49 referenced in the primary outcome description, 37 with completed logs, and safety denominators of 49 and 37—show why participant flow and analysis populations should be transparent. The record does not explain these counts. For biostatisticians and clinical researchers, this is a useful case in distinguishing study purpose, outcome definition, data availability, analysis, and inference. Each is necessary to understand what the record can and cannot establish.

14. 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.

Several limitations are specific to the information recorded for this study. The design is single-group, allocation is listed as NA, and masking is none. There is no randomized control comparison, so the record cannot establish how symptom reports would have differed under a comparator condition. Because the primary outcome is based on parental ratings, interpretation also depends on reported observations rather than an independent symptom assessment described in the registry.

The outcome counts improvement separately for four symptoms and uses a binary classification of at least some improvement or better versus no improvement or worse. This does not preserve the size of a change, and the record does not report whether severity was assessed. The one-hour assessment time and study-log format define the observation window, but do not describe symptom trajectories beyond that timing. The record does not report an analysis of repeated observations or how the varying numbers of symptom-present doses were handled.

Completed logs were received from 37 of 49 enrolled participants, but the reasons for incomplete logs and the handling of missing data are not reported in the registry record. The registry lists enrollment as 50, without explaining the difference from the 49 noted in the primary outcome description. Safety denominators also vary, and the record does not explain why. There are 0 analyses listed, and no primary efficacy estimate or uncertainty measure is reported. The registry record does not report a sample-size justification, a statistical analysis plan, or details about multiplicity. These reporting gaps prevent a more complete assessment of the planned and performed analyses.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Homeopathic Cold Medicine for Children — NCT00858494.
• Registry record last updated 2018-07-26; status last verified 2018-07.
• Results first posted 2011-03-03.
• 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.

18. Record Summary

NCT00858494 is a completed, single-group study titled Homeopathic Cold Medicine for Children, sponsored by the University of Washington. It lists an enrollment of 50 and evaluates Hyland's Cold 'n Cough 4 Kids in children with upper respiratory tract infection. The primary outcome counts parental reports of improvement in runny nose, cough, nasal congestion, and sneezing one hour after a dose. The registry describes completed logs from 37 of 49 enrolled participants and gives symptom-present dose counts, but does not report improvement counts or an efficacy analysis. The safety table lists 0 serious events among 49 at risk and 2 other events among 37 at risk. The study has no randomized comparator, and the registry lists 0 analyses.