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 A Prospective Trial of Ayurveda for Coronary Artery Disease (NCT02228343), a na na study. The primary outcome is Participants With Arterial Stiffness Were Measured as Pulse Wave Velocity Meters/Second.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02228343 |
| Phase | NA |
| Condition | Coronary Artery Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of New Mexico |
| Results posted | Yes |
2. Clinical Question
Population
Participants with coronary artery disease. The registry record lists 22 participants enrolled. It does not give additional eligibility details or describe the characteristics of the enrolled group.
Intervention
Ayurvedic therapy, listed as an intervention of type “other.” The registry record does not describe the treatment components, delivery schedule, or adherence.
Comparator
No separate comparator group is listed. The study model is single-group, and allocation is recorded as NA, so the record does not describe a randomized, concurrent comparison.
Primary question
The study asks whether Ayurvedic therapy can improve markers of cardiovascular health and cardiovascular risk factors in people with coronary artery disease. The listed primary outcome concerns participants with arterial stiffness measured using pulse wave velocity, with a timeframe of 3 months. The record does not report an outcome result or analysis answering that question.
3. Trial Design
The registry describes a prospective trial of Ayurveda for coronary artery disease. It is marked completed, with the University of New Mexico listed as sponsor. The recorded start is 2013-01 and the primary completion is 2013-10. The phase is NA. Enrollment is listed as 22.
The study model is single-group, and the only intervention listed is Ayurvedic therapy. Allocation is recorded as NA, and masking is listed as none. There is no separate control arm or randomized comparison described in the registry record. Consequently, the listed design does not provide a concurrent group against which to compare changes during the study.
The primary outcome is described in terms of participants with arterial stiffness measured as pulse wave velocity in meters per second, with a timeframe of 3 months. The registry classifies the outcome as a count of participants, but does not report the number meeting the outcome definition, the actual pulse wave velocity measurements, or an analysis. There is one outcome measure listed and 0 analyses.
The record does not report the treatment protocol, visit schedule, eligibility criteria, planned statistical analysis, or a sample-size justification. Its sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are described as illustration assumptions rather than the trial’s design; the record does not give the numerical illustration results or an observed effect estimate.
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 | Ayurveda |
|---|---|
| STARTED | 22 |
| COMPLETED | 19 |
| NOT COMPLETED | 3 |
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 | Ayurveda |
|---|---|---|
| Participants analysed | 22 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 22 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | NA |
| Sex: Female, Male: Male | Participants | NA |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | Participants | 22 |
6. Primary Endpoint
The registry lists the primary outcome as Participants With Arterial Stiffness Were Measured as Pulse Wave Velocity Meters/Second, measured over 3 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Participants With Arterial Stiffness Were Measured as Pulse Wave Velocity Meters/Second.” Pulse wave velocity (PWV) expresses how quickly a pressure wave travels through the arteries and is used as a measure related to arterial stiffness. In general, such a measure can be used to assess a vascular characteristic, rather than a clinical event such as hospitalization or death.
The registry lists the endpoint unit as participants and the parameter as a count of participants, while the title refers to a measurement in meters per second. That distinction matters: a continuous PWV value and a count of participants meeting a definition are different kinds of outcome. The record does not explain what threshold or classification defines a participant as having arterial stiffness, whether the endpoint is a change from an earlier measurement, or how repeated measurements would be handled.
The listed timeframe is 3 months. This indicates the stated assessment timeframe, but the registry record does not give actual PWV values, the number of participants with arterial stiffness, or a result at that time. It also does not describe why this endpoint was selected as primary or how it relates to the broader question about cardiovascular health markers and risk factors.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the clinical topic, intervention, single-group model, enrollment, and primary outcome, but it does not report an outcome analysis. Although one outcome measure is listed, the record lists 0 analyses. No count of participants with arterial stiffness, PWV summary, estimate of change, uncertainty interval, or statistical test result is reported. Therefore, the posted information does not quantify the primary outcome or establish how it changed during the study.
The listed endpoint also requires careful interpretation because its title refers to PWV measured in meters per second, while its unit and parameter describe a count of participants. The record does not state the classification rule needed to turn a PWV measurement into a participant count. Without that rule and the corresponding outcome data, readers cannot determine what the endpoint count represents or compare it with a measurement-based result.
The single-group design is another important consideration. With no separate comparator group listed, any changes measured over time would not, by themselves, distinguish a treatment-associated change from other explanations. In general, a concurrent comparison can help separate changes associated with an intervention from changes that might occur over time or from other influences. The registry does not report a comparison of that kind.
The enrollment figure is 22, while the adverse-event figures use 19 participants at risk. The record does not explain the difference in the denominators, and the adverse-event group should not be treated as the primary-outcome population. The primary outcome’s analysis population and any missing outcome data are not reported in the registry record.
The safety listing records no serious adverse events, other adverse events, or deaths among the 19 participants at risk. These are descriptive counts in the registry record; they do not provide comparative rates or establish how safety would compare with another group. The record does not provide enough information to estimate the precision of an intervention effect on either the primary endpoint or safety outcomes.
Overall, the registry documents that a study was completed, but does not post the numerical results needed to assess the stated primary question. The absence of a posted analysis should not be read as evidence of no change or as evidence of a particular treatment effect.
9. Statistical Methods Explained
What does a single-group design imply?
The registry classifies this study as single-group and lists Ayurvedic therapy as its intervention. Allocation is NA, and no comparator group is described. In general, a single-group study can describe what was observed among participants who received an intervention, but it cannot make a direct within-trial contrast with a separate untreated or alternative-treatment group when none is listed. Even if a before-and-after change were reported, interpreting that change as caused by the intervention would require assumptions that the registry record does not address.
How should the primary outcome be understood?
The endpoint title refers to participants with arterial stiffness measured as PWV in meters per second. The endpoint parameter, however, is a count of participants. A count outcome generally records how many people meet a stated condition; a PWV measurement in meters per second is a measurement on a numerical scale. In general, a count based on a measurement needs a definition, such as a classification rule. The registry record does not state such a rule or report the measurement values, so the endpoint’s operational definition cannot be reconstructed from the record.
What can an estimate and confidence interval show?
In general, an effect estimate describes the magnitude and direction of an observed difference or change, while a confidence interval describes the statistical uncertainty around that estimate under the method’s assumptions. A narrow interval usually indicates greater precision than a wide interval, though precision does not establish that an estimate is free from bias or clinically important. Here, no primary outcome estimate or confidence interval is reported in the registry record. No conclusion about the magnitude, direction, or precision of a primary outcome effect can therefore be drawn from the posted results.
What does the record say about planning calculations?
The registry describes a sample-size planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. In general, a sample-size calculation uses assumptions about the effect, variability, error rate, allocation, and analysis method to illustrate a possible design requirement. It is not a count of participants actually analyzed and is not a measure of the probability that a completed study found a true effect.
The illustration assumptions do not describe the design listed for this trial: the registry identifies a single group, not equal allocation between two arms. The record also reports no observed effect estimate or numerical sample-size illustration values. Consequently, the assumptions cannot be used to infer the trial’s original design rationale, its statistical power, or the precision of any result. The sample-size justification for the trial itself is not reported in the registry record.
Why does over-dispersion matter in general?
For count outcomes, some statistical models assume that the observed variation follows a particular relationship to the average count. Over-dispersion means the data vary more than that model expects. If it is ignored, standard errors may be understated and intervals or tests may appear more certain than warranted. This is a general issue for count-data analysis; the registry record does not report a count model, an over-dispersion assessment, or enough outcome data to evaluate whether it applies.
What can zero listed analyses establish?
The registry lists 0 analyses. This means no analysis results are posted in the record, but it does not establish what analyses may have been conducted outside the registry. The statistical analysis plan, model specification, treatment of repeated measurements, adjustment for baseline values, and handling of incomplete observations are not reported in the registry record. Without those details and the numerical outcome data, readers cannot reproduce or evaluate a primary-outcome analysis.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Ayurveda | 19 | 19 | 100.0% | 82.4% to 100.0% | 83.2% to 100.0% | 83.2% to 99.9% |
R code and output
arm <- c("Ayurveda")
n <- c(19)
events <- c(19)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Ayurveda 19 19 100.0 82.4 100.0 83.2 100.0 83.2 99.911. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and 0 analyses. It does not report whether other outcomes were assessed outside the listed measure, whether the primary endpoint was selected before results were examined, or whether any multiplicity procedure was planned. Multiplicity concerns can arise when many outcomes or tests are examined, because the chance of at least one apparently unusual result can increase. That general issue cannot be quantified for this trial from the registry information.
The record does not describe a missing-data method, the number of participants with primary outcome data, or reasons for any missing measurements. It also does not state whether all enrolled participants were included in an analysis or define an analysis population. The enrolled total is 22, but the registry gives no primary-outcome denominator. The 19 participants listed as at risk in the adverse-event information are a safety denominator and cannot be assumed to be the primary-outcome population.
Without a stated approach to incomplete data, readers cannot tell whether the posted outcome—if reported elsewhere—would represent all enrolled participants or a subset. In general, missingness can affect an estimate when participants without measurements differ systematically from those with measurements. Assessing that possibility requires information about completeness, reasons for missingness, and the analysis approach. These details are not reported in the registry record.
The registry also does not report a statistical analysis plan or methods for handling multiple time points, repeated measurements, or other outcome comparisons. Those choices can affect the interpretation of uncertainty and statistical tests. No significance tests or estimates are posted, so there is no multiplicity-adjusted or unadjusted result to interpret.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Ayurveda | 0 | 19 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Ayurveda | 0 of 19 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ayurveda | 0 of 19 |
The adverse-event listing reports 0 serious adverse events among 19 participants at risk in the Ayurveda group. It also reports 0 other adverse events and 0 deaths among the same 19 participants at risk. No serious adverse-event terms are listed.
These are descriptive counts for the participants recorded as at risk. They do not mean that the trial established an absence of risk, and they do not compare safety with another intervention or a control group. The record does not state how adverse events were defined, how actively they were monitored, or the period covered by the adverse-event counts. It also does not explain why the safety denominator is 19 when total enrollment is listed as 22.
In general, a zero count in a study group is interpreted in the context of the number observed, follow-up, event definitions, and completeness of reporting. No comparative estimate or uncertainty interval for adverse events is reported in the registry record. The figures should therefore be read narrowly as the counts posted for this group, rather than as proof that adverse events could not occur.
13. What the Result Does, and Does Not, Mean
The registry record establishes that a completed, prospective, single-group study of Ayurvedic therapy in people with coronary artery disease was registered. It identifies an intended primary outcome related to arterial stiffness and PWV, with a 3 months timeframe. It also posts safety counts for the Ayurveda group. These details describe the recorded study and the outcomes that were intended or listed.
The record does not report the primary outcome values or an analysis. It therefore does not show whether PWV changed, how many participants met the arterial-stiffness definition, or how precisely any change was estimated. It does not provide a numerical result that answers whether the intervention improved cardiovascular-health markers or cardiovascular risk factors.
The design information also limits the kinds of conclusions that could be supported by a result. No concurrent comparator is listed, so a change over time, if reported elsewhere, would not itself establish that the intervention caused the change. General sources of change unrelated to treatment cannot be separated from treatment effects by a single-group contrast alone.
The adverse-event listing records zero serious adverse events, zero other adverse events, and zero deaths among 19 participants at risk. Those counts describe the posted registry data only. They do not establish comparative safety or rule out events in a broader population.
Accordingly, the registry record is informative about the study’s setting and structure but does not provide sufficient outcome information to estimate benefit, harm, or statistical uncertainty. The absence of a posted primary analysis is not evidence of either a favorable or an unfavorable result.
14. Why This Trial Matters Statistically
This trial is statistically notable because the registry identifies a clinically relevant measurement question but posts no primary outcome analysis. Readers can see that arterial stiffness assessed using PWV was the stated endpoint, yet cannot evaluate an effect estimate, its uncertainty, or the data underlying it. The distinction between an outcome described as a PWV measurement and one coded as a count of participants also shows why clear endpoint definitions are essential for interpreting results.
The single-group model makes the distinction between description and comparison especially important. A study may record measurements in participants receiving an intervention, but a treatment effect is generally a contrast. Without a separate comparison group in the registry record, the intended clinical question cannot be answered through a randomized between-group estimate from this study design.
The record also illustrates why sample-size planning information must be read in context. The stated planning assumptions describe equal allocation between two arms, whereas the registered model is single-group. The assumptions are explicitly an illustration, and the record gives neither a numerical illustration nor a reported observed effect. They should not be mistaken for the trial’s documented design justification or for evidence about the precision of its results.
Finally, the difference between the enrolled total and the safety risk denominator, alongside the lack of a primary outcome denominator, highlights the importance of transparent analysis populations and missing-data reporting. These details are necessary to judge who contributed to an estimate and whether the results may represent the enrolled group. In this record, those questions remain unresolved.
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 principal limitation for statistical interpretation is that no primary outcome analysis is reported. Although the registry lists one outcome measure, it provides no count of participants with arterial stiffness, PWV values, effect estimate, confidence interval, or test result. The stated 3 months timeframe does not substitute for an observed result.
The endpoint is not operationally clear from the record. Its title describes participants with arterial stiffness measured as PWV in meters per second, while the unit and parameter identify a participant count. The threshold or other rule used to classify participants is not reported. Nor is it clear whether the intended result was a level, a change, or a count derived from a measurement.
The study is listed as single-group, with no comparator arm. This prevents a concurrent comparison within the registered design and limits causal interpretation of any change that might be reported elsewhere. Masking is listed as none, and the record does not provide further information about assessment procedures that could clarify how outcome measurement was conducted.
Enrollment is listed as 22, but the adverse-event denominator is 19. The registry does not explain this difference or provide the primary-outcome denominator. Eligibility criteria, participant characteristics, treatment details, adherence, follow-up completeness, and reasons for missing data are not reported in the registry record.
The record lists 0 analyses and does not report a statistical analysis plan, multiplicity strategy, or sample-size justification for the trial. Its planning assumptions are illustrative and do not supply the missing outcome results. These omissions prevent assessment of analysis choices, data completeness, and precision.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: A Prospective Trial of Ayurveda for Coronary Artery Disease — NCT02228343.
- Registry record last updated 2024-08-01; status last verified 2024-02.
- Results first posted 2024-08-01.
- 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.
19. Record Summary
The registry record describes NCT02228343, “A Prospective Trial of Ayurveda for Coronary Artery Disease,” sponsored by the University of New Mexico. It is marked completed, with a recorded start of 2013-01, primary completion of 2013-10, and enrollment of 22. The design is prospective and single-group; Ayurvedic therapy is the only intervention listed. Allocation is NA, masking is none, and phase is NA.
One primary outcome is listed: participants with arterial stiffness measured as PWV in meters per second, with a timeframe of 3 months. The registry records 0 analyses and reports no primary outcome result. Adverse-event data list 0 serious adverse events, 0 other adverse events, and 0 deaths among 19 participants at risk. No serious-event terms are listed. The record does not explain the outcome definition, analysis population, or safety denominator.