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 Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS) (NCT01483118), a randomized phase 3 study. The primary outcome is Number of Menses During the Six Month Study Period..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01483118 |
| Phase | Phase 3 |
| Condition | Polycystic Ovary Syndrome |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 45 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Rogerio A. Lobo |
| Results posted | Yes |
2. Clinical Question
Population
The study was intended for people with polycystic ovary syndrome (PCOS) and oligomenorrhea, meaning infrequent menstrual periods. The registry summary describes the primary purpose as assessing whether cinnamon could restore menstrual cyclicity in this population. It does not report further eligibility details, such as how oligomenorrhea was defined or which other characteristics were required.
Intervention
One group received cinnamon extract. The registry identifies this intervention as a drug and describes the arm as receiving cinnamon capsules. It does not report the dose, schedule, or other administration details in the available record.
Comparator
The comparison group received placebo capsules. The registry identifies the placebo intervention as a dietary supplement. Details about the placebo’s contents or how closely it matched the cinnamon capsules are not reported in the registry record.
Primary question
The primary question was whether the number of menses during the study differed between the cinnamon extract and placebo groups. The outcome was specified over up to 6 months, with ovulatory cycles to be confirmed using serum progesterone levels. The registry does not report the numerical outcome by group or a treatment-effect estimate.
3. Trial Design
The registry describes a randomized, double-masked, parallel-group phase 3 trial, marked as completed. Its listed enrollment is 45. Participants were assigned to cinnamon extract or placebo, with the stated aim of evaluating menstrual cyclicity in people with PCOS and oligomenorrhea. A parallel-group design compares groups receiving different interventions over the same study period, rather than having each participant receive both interventions in sequence. In general, random allocation is intended to reduce systematic differences between groups at the start of a trial; the registry does not describe the randomization sequence or allocation-concealment procedures.
The registry gives a start date of 2011-03 and a primary completion date of 2013-05. Those dates describe the trial record’s timing, not the duration each participant was followed. The primary outcome timeframe is listed as up to 6 months. The record does not provide further details about individual follow-up, treatment adherence, or whether participants could discontinue treatment while continuing outcome assessments.
The intervention arms are named Cinnamon Extract Arm and Placebo Arm. The registry summary identifies confirmation of ovulatory cycles by serum progesterone levels. Change in insulin resistance and change in glucose response are listed as secondary outcomes, consistent with the summary’s stated secondary aim. The registry record does not report the intervention dose, the detailed protocol, the study locations, or the operational procedures used to maintain masking. The counts at risk in the safety record are 23 for the cinnamon extract arm and 22 for the placebo arm; those safety denominators should not be treated as a complete account of outcome-specific analysis populations.
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 | Cinnamon Extract Arm | Placebo Arm |
|---|---|---|
| STARTED | 23 | 22 |
| Completed 3 Months | 15 | 11 |
| COMPLETED | 11 | 6 |
| NOT COMPLETED | 12 | 16 |
Reasons for not completing this period:
| Reason | Cinnamon Extract Arm | Placebo Arm |
|---|---|---|
| Lost to Follow-up | 12 | 16 |
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 | Cinnamon Extract Arm | Placebo Arm | Total |
|---|---|---|---|---|
| Participants analysed | 23 | 22 | 45 | |
| Age, Continuous | years | 26.95 (18 to 34) | 27.86 (18 to 38) | 27.5 (18 to 38) |
| Sex: Female, Male: Female | Participants | 23 | 22 | 45 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 8 | 8 | 16 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 14 | 13 | 27 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 2 |
| Region of Enrollment: United States | participants | 23 | 22 | 45 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Menses During the Six Month Study Period., measured over Up to 6 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | Number of menstrual cycles per month |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is titled “Number of Menses During the Six Month Study Period.” The registry describes the measure as the number of menstrual cycles per month, uses the median as its summary measure, and specifies the inter-quartile range as the measure of spread. The timeframe is up to 6 months. These labels indicate that the endpoint concerns menstrual activity over the follow-up period and that the planned summary emphasizes the midpoint and distribution rather than the arithmetic average.
The registry states that ovulatory cycles will be confirmed by serum progesterone levels. This distinction matters because observing menstrual bleeding alone does not establish that a cycle was ovulatory. In general, a biological confirmation measure can help distinguish the event of interest from other events that may look similar at the level of symptoms. The record does not describe the timing or threshold for progesterone testing, how cycles were counted, or how incomplete follow-up was handled.
Menstrual cyclicity was the primary focus because the stated purpose was to determine whether cinnamon could restore regularity among PCOS subjects with oligomenorrhea. The endpoint is therefore a measure of reproductive-cycle activity, not a direct measure of insulin resistance or glucose response. Those are listed separately as secondary outcomes. Numerical medians, inter-quartile ranges, and a between-group analysis for the primary endpoint are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and the trial’s broad design, but it does not report numerical results for the number of menses during the study period. It also does not report a between-group estimate, confidence interval, test statistic, or p-value for that endpoint. Consequently, the posted registry information does not establish the size, direction, or precision of any difference in menstrual activity between the cinnamon extract and placebo groups. No conclusion about an effect on menstrual cyclicity can be drawn from the endpoint description alone.
The record lists change in insulin resistance and change in glucose response as secondary outcomes. Numerical results for these outcomes are not reported in the registry record either. The summary’s stated interest in these measures describes the research rationale; it is not evidence of an observed result. The registry record lists three outcome measures and zero analyses, but does not supply outcome estimates or describe how the outcomes were analyzed.
In general, a treatment-effect estimate describes the contrast between groups, while a confidence interval conveys the range of effect values compatible with the data and the analysis assumptions. Without estimates and intervals, readers cannot assess either the magnitude of a difference or its precision. A p-value, if reported, would address compatibility with a specified null model, not the size or clinical importance of an effect. No p-value is available for the primary outcome in the registry record.
The safety record gives counts for serious and other adverse events. These are descriptive counts, not a complete evaluation of comparative safety. In the cinnamon extract arm, 1 participant was recorded as having a serious adverse event among 23 at risk; in the placebo arm, 0 were recorded among 22 at risk. Other adverse events were recorded for 15 of 23 and 13 of 22 participants, respectively. The record does not provide enough context to infer that an event was caused by either intervention, or to determine whether the groups differ meaningfully in safety.
Planning illustrations based on an observed effect should be read as hypothetical design calculations, not as observed power or proof that a study had a particular probability of detecting an effect. The registry does not report the numerical planning results or the trial’s own sample-size justification. Overall, the information recorded establishes what the study intended to measure and gives some adverse-event counts, while leaving the central efficacy results unreported.
9. Statistical Methods Explained
The registry describes a randomized, double-masked, parallel-group trial. In general, random allocation aims to make treatment groups comparable with respect to both measured and unmeasured characteristics, on average. Masking is intended to limit the influence of treatment knowledge on participant behavior, care, and outcome assessment. The record identifies the design labels but does not describe how randomization or masking was implemented, who remained masked, or how masking was assessed. Those procedural details are not reported in the registry record.
Why summarize the endpoint with a median?
The primary outcome is specified as a median with an inter-quartile range. In general, the median is the central value after observations are ordered. The inter-quartile range describes the spread of the middle portion of the observations. These summaries can be useful when data are skewed or when unusually high or low observations could strongly influence an average. They do not, by themselves, quantify a treatment contrast. To compare groups, an analysis needs to specify how the distributions or chosen summaries are contrasted and how uncertainty is estimated. That analysis is not reported in the registry record.
The endpoint is described as the number of menstrual cycles per month during up to 6 months, while its title refers to the number of menses during the six month study period. The registry does not explain the precise derivation of this measure or how cycle counts were combined across follow-up. It also does not report the distribution of individual observations. Readers therefore cannot verify from the record how the endpoint was constructed or whether the planned summary was applied as written.
What does progesterone confirmation add?
The registry states that ovulatory cycles will be confirmed by serum progesterone levels. In general, an objective laboratory measure can support classification of an event when the clinical event alone does not identify the biological process of interest. This requires a prespecified measurement schedule and definition of a qualifying result. The details of that schedule and definition are not reported in the registry record. The record also does not explain how a cycle without an available progesterone measurement would be classified.
How should the planning assumptions be understood?
The sample-size assumptions describe a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation. They also specify that the effect to detect is a stated fraction of the observed effect. These assumptions describe a calculation framework, not evidence about the trial’s actual statistical plan. The numerical planning results and the trial’s own sample-size justification are not reported in the registry record. A sample-size illustration is not observed power: it cannot show that the trial had a particular probability of detecting an effect after the data were collected.
In general, a sample-size calculation depends on the target effect, variability, chosen error rate, allocation, and analysis method. Changing the target effect changes the number of participants needed under the calculation assumptions. A calculation based on an effect observed in a study can be especially uncertain as a planning reference because the observed effect itself may be imprecise. The record does not provide the numerical observed effect used for the illustration, so the illustration’s magnitude cannot be evaluated from the registry information.
What can adverse-event counts establish?
The safety record reports numbers at risk and numbers with serious or other adverse events by arm. In general, such counts describe how many participants were recorded in each category during the period covered by the safety collection. They do not automatically establish that an intervention caused an event. Interpretation also depends on definitions, follow-up duration, event ascertainment, and whether participants with different follow-up contribute comparable opportunities for an event. Those details are not reported in the registry record. The record does not provide a comparative statistical analysis of adverse events.
There is no sponsor-reported treatment-effect analysis in the registry record for the primary endpoint, and numerical results for the secondary endpoints are not reported. General statistical concepts can explain what a median, inter-quartile range, or confidence interval would mean, but they cannot replace the missing outcome estimates. The registry’s design labels and endpoint definitions identify the intended framework; they are not a substitute for the prespecified analysis details or the resulting estimates.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome, the number of menses during the study period, and two secondary outcomes: change in insulin resistance and change in glucose response. When a study evaluates multiple outcomes, there may be more than one opportunity to observe a result that appears noteworthy by chance. In general, multiplicity procedures specify how the analysis will account for that possibility, for example by prioritizing an outcome or adjusting inference across several tests. The registry record does not report a multiplicity strategy, testing hierarchy, or adjustment method. This absence does not establish what procedures were used outside the registry record.
Missing-data handling is also not described. The record does not state how incomplete menstrual-cycle observations, missing progesterone measurements, withdrawals, or unavailable secondary-outcome measurements were handled. In general, missingness can affect an estimate if participants with missing observations differ systematically from those with complete observations. The implications depend on why data are missing and on the methods used; neither is described in the registry record.
The analysis population is not reported in the registry record. It does not specify whether the primary analysis included everyone randomized, only participants who completed treatment, or another defined group. Nor does it describe how participants were analyzed if they stopped treatment or did not follow the assigned intervention. These choices affect what comparison an estimate represents.
The record lists zero analyses and provides no numerical outcome estimates. It therefore does not allow readers to determine whether multiplicity, missing data, or analysis-population choices influenced any reported treatment-effect result. A protocol or statistical analysis plan could contain more detail, but such information is not reported in the registry record.
11. 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 |
|---|---|---|---|
| Cinnamon Extract Arm | 1 | 23 | 4.3% |
| Placebo Arm | 0 | 22 | 0.0% |
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 |
|---|---|
| Cinnamon Extract Arm | 15 of 23 |
| Placebo Arm | 13 of 22 |
Most frequent serious adverse event terms
| Event term | Organ system | Cinnamon Extract Arm | Placebo Arm |
|---|---|---|---|
| Right leg swelling with pain | General disorders | 1 of 23 | 0 of 22 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cinnamon Extract Arm | Placebo Arm |
|---|---|---|---|
| Headache | General disorders | 10 of 23 | 9 of 22 |
| Menstrual cramps | Reproductive system and breast disorders | 6 of 23 | 3 of 22 |
| Back pain | General disorders | 3 of 23 | 1 of 22 |
| Cold | General disorders | 3 of 23 | 1 of 22 |
| Nausea | General disorders | 3 of 23 | 1 of 22 |
| Diarrhea | Gastrointestinal disorders | 3 of 23 | 0 of 22 |
| Heartburn | Gastrointestinal disorders | 3 of 23 | 0 of 22 |
| Migraine | General disorders | 2 of 23 | 1 of 22 |
| Stomachache | General disorders | 3 of 23 | 0 of 22 |
| Sore throat | General disorders | 1 of 23 | 1 of 22 |
Serious events with the highest arm-level rate: right leg swelling with pain (4.3%).
For serious adverse events, the registry records 1 affected participant among 23 at risk in the Cinnamon Extract Arm and 0 among 22 at risk in the Placebo Arm. For other adverse events, it records 15 affected participants among 23 at risk in the cinnamon arm and 13 among 22 at risk in the placebo arm. These figures are counts within the listed safety groups. They do not provide an adjusted comparison or show whether an event was caused by the assigned intervention.
The registry identifies “Right leg swelling with pain” as the top serious adverse-event term, with 4.3% listed. The safety record does not report death counts. It also does not describe the event-collection period, severity criteria beyond the serious-event category, or the rules for attributing events to treatment. In general, adverse-event counts are best interpreted alongside consistent follow-up, clear definitions, and full information about who was monitored. The counts alone do not establish comparative safety or explain the clinical circumstances of an event.
12. What the Result Does, and Does Not, Mean
The record describes a randomized comparison intended to test whether cinnamon extract could affect menstrual cyclicity in people with PCOS and oligomenorrhea. It specifies the primary outcome, a median and inter-quartile range as its summary, and progesterone confirmation of ovulatory cycles. These details clarify the research question and the intended measurement. They do not reveal what the trial found: numerical primary-outcome results and a treatment-effect estimate are not reported in the registry record.
The absence of a reported estimate is different from evidence that the groups were the same. Without results and uncertainty measures, readers cannot distinguish a small difference from a larger but imprecise one, or assess whether the data are compatible with a range of possible effects. The record likewise does not report numerical findings for the secondary outcomes of insulin resistance and glucose response. The stated aims should not be mistaken for results.
The serious and other adverse-event counts provide limited descriptive safety information. They do not establish causality, and the registry does not report a statistical comparison or detailed context for those events. The listed serious term and percentage should be read as a registry entry, not as a complete account of all safety evidence.
In general, trial interpretation depends on the observed estimates, their precision, the analysis population, and the handling of missing data, among other considerations. Those details are not reported in the registry record. The study’s completed status and phase designation do not supply the missing outcome results. As a result, the record supports a description of the trial’s question and some safety counts, but not a conclusion about the effect of cinnamon extract on menstrual cyclicity or the secondary outcomes.
13. Why This Trial Matters Statistically
This trial is statistically notable because its primary endpoint concerns repeated menstrual activity over a follow-up period, with ovulatory cycles intended to be confirmed by a laboratory measure. That combination raises practical analysis questions: how cycles are counted, how incomplete follow-up is handled, and how laboratory confirmation is incorporated. The registry identifies the endpoint and its summary measure, but does not report the detailed rules needed to evaluate those choices.
The specified median and inter-quartile range indicate an emphasis on the distribution of the endpoint rather than only its average. In general, reporting a distributional summary can help readers understand how observations vary, but a group summary is not itself a direct estimate of the difference between groups. A treatment comparison and its uncertainty are needed to judge the strength and precision of evidence. Such numerical results are not reported in the registry record.
The trial also lists two secondary outcomes alongside its menstrual-cycle endpoint. Considering several outcomes makes clear why a statistical analysis plan matters: it can distinguish the primary question from additional questions and set out how results will be interpreted. The registry record does not describe a multiplicity approach, analysis populations, missing-data procedures, or a detailed statistical analysis plan.
Finally, the safety entries illustrate the difference between descriptive counts and comparative inference. Counts can report what was recorded in each group, but interpretation depends on event definitions, monitoring, follow-up, and the analysis. Those details are limited in the registry record. Taken together, this study highlights how outcome definitions and analysis choices shape interpretation, while also showing the limits of a registry entry that lacks numerical efficacy results.
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.
The central limitation of the registry record is that it does not report numerical results for the primary endpoint. Group medians, inter-quartile ranges, a treatment-effect estimate, and its uncertainty are not reported in the registry record. Numerical results for change in insulin resistance and change in glucose response are also not reported. Without these results, the intended efficacy comparison cannot be evaluated.
Important design and analysis details are not reported in the registry record. These include the randomization procedure, allocation concealment, intervention dose and schedule, masking procedures, detailed eligibility criteria, and the precise method for constructing the menstrual-cycle endpoint. The registry also does not specify how progesterone results were timed or classified, or how missing measurements and incomplete follow-up were handled.
The analysis population, statistical model, multiplicity strategy, and analysis plan are not reported. The record does not provide the trial’s own sample-size justification or numerical planning results. Therefore, readers cannot assess whether the analysis matched a prespecified plan or how sensitive an estimate might be to alternative assumptions. The safety entries give counts but do not describe collection methods, follow-up duration, or attribution procedures. These limitations concern the information available in the registry record and should not be taken as proof that such procedures were absent from the trial.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS) — NCT01483118.
- Registry record last updated 2017-10-03; status last verified 2017-06.
- Results first posted 2017-08-02.
- 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.
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18. Record Summary
NCT01483118 is listed as a completed, randomized, double-masked, parallel-group phase 3 trial of cinnamon extract versus placebo for PCOS. The record gives enrollment of 45, a start date of 2011-03, and a primary completion date of 2013-05. Its primary outcome is the number of menses during the study period, summarized by median and inter-quartile range, with ovulatory cycles to be confirmed by serum progesterone. Change in insulin resistance and change in glucose response are listed as secondary outcomes.
The registry record does not report numerical efficacy results, a treatment-effect analysis, or details of the statistical analysis plan. Safety entries include serious and other adverse-event counts by arm, but do not establish causation or provide a comparative analysis. The record therefore describes the study’s purpose, design, and selected safety information without reporting the primary outcome findings.