The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study (NCT02290925), a randomized phase 3 study. The primary outcome is Glycosylated Haemoglobin.

2. Clinical Question

This is a question about a laboratory measure, not a direct measure of how participants felt or functioned. The registry describes a randomized, placebo-controlled crossover study in people with type 2 diabetes. In a crossover design, participants may receive more than one study condition in sequence, allowing a comparison that can account for stable differences between individuals. The record identifies a two-period, two-sequence design, but does not report how many participants completed each period or how the sequences were assigned in practice.

The clinical question is therefore identifiable at a broad level: whether glycosylated haemoglobin differed across the study conditions at the stated assessment times. The record does not give a direction, magnitude, confidence interval, or statistical test for that comparison. It also does not establish which time point or comparison was used as the single primary analysis. The registry states that the primary outcome has several categories or time points and was not reduced to one comparison.

3. Trial Design

The registry describes NCT02290925 as a completed, randomized, phase 3 crossover clinical trial sponsored by Rajarata University, Sri Lanka. Its listed condition is type 2 diabetes mellitus, and the enrollment is 133. The record gives a start date of 2014-05 and a primary completion date of 2017-04. These dates describe the registry record; they do not supply details about recruitment pace, follow-up completion, or the timing of individual assessments.

The official title describes a randomized, placebo-controlled, two-period, two-sequence crossover trial. The planned comparison was between a biscuit containing Salacia reticulata extract and an identical biscuit without the extract. The active-biscuit description specifies four biscuits twice a day for 3 months. It does not give the placebo biscuit’s dose or duration separately. The primary outcome timeframe lists measurements after 3 months and after 7 months and notes a one-month wash-over period. The record does not describe the sequence assignments or confirm that every participant completed both periods.

There is a difference in the record’s masking descriptions: the official title says triple blind, while the structured masking entry says quadruple. The record does not identify the parties included in either description or explain the difference, so the masking level cannot be resolved from the registry record alone.

The primary outcome is glycosylated haemoglobin, reported as a mean with standard error and measured as a percentage of glycosylated hemoglobin. The description says it was analyzed at a centrally accredited laboratory using ion exchange high performance liquid chromatography standardized to NGSP. Listed secondary outcomes concern liver adverse effects and two renal adverse-effect measures. The registry reports four outcome measures and one analysis, but does not give a full statistical analysis plan, analysis population, or outcome results. The study status is completed; completion does not by itself establish that all planned observations or analyses are reported.

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: Run-in period was 8 weeks and if the variability of the HbA1c is more than 20%, participants were excluded. This was done to exclude patients with fluctuating glycaemia. Wash out for 1 month after 1st period of giving treatment for 3 months. After the wash out patients are crossed over for the other biscuit given for another three months

First Period of Three Months

Reasons for not completing this period:

Second Period of 3 Months

Reasons for not completing this period:

5. Baseline Characteristics

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

6. Primary Endpoint

The registry lists the primary outcome as Glycosylated Haemoglobin, measured over After 3 months and after 7 months (there is one month wash over period as this is a cross over trial).

The primary endpoint is glycosylated haemoglobin, also referred to in the record as HBA1c. It is a laboratory measure of glycosylated hemoglobin, reported as a percentage. The registry says samples were analyzed at a centrally accredited laboratory using ion exchange high performance liquid chromatography standardized to NGSP.

As general context, glycosylated haemoglobin reflects glucose exposure over a longer period than a single blood glucose measurement. That makes it useful for assessing longer-term glycaemia in studies of diabetes. It does not describe every fluctuation in blood glucose, nor does it by itself capture symptoms, daily functioning, or all aspects of diabetes care. A laboratory measure can be informative while still representing only one part of a broader clinical picture.

The registry lists the endpoint as a mean with standard error, with assessment after 3 months and after 7 months. It also identifies a one-month wash-over period because the study used a crossover design. The registry does not report the mean values at either assessment, the contrast between the biscuits, or a confidence interval. It also does not specify in the posted record which time point or combination of time points defines the primary comparison. Consequently, the measurement method and timing are described, but the observed glycosylated-haemoglobin result cannot be interpreted from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry calls the primary outcome continuous and describes it as a mean with standard error. Those terms identify the type of summary intended, but not the statistical model used to compare the biscuits. The record does not report the actual means, standard errors, treatment contrast, confidence interval, or p-value. It also does not identify an analysis population or explain which of the listed time points was the principal comparison.

What a mean and standard error describe

In general, a mean is the arithmetic average of observed measurements. It gives a central summary but does not show the full distribution. Two groups can have the same mean while having different amounts of variation among participants. The standard error describes the uncertainty, or sampling precision, of an estimated mean. It is not the standard deviation and should not be read as the range containing most individual measurements.

For an estimated treatment contrast, a confidence interval is generally useful because it expresses the precision of that contrast and the range of values compatible with the data under the model. A p-value, when reported, addresses how compatible the observed data are with a specified null hypothesis under the analysis assumptions; it does not measure the size or clinical importance of an effect. Neither statistic is reported for the primary outcome in the registry record. Without the estimate and its uncertainty, the result cannot be characterized as precise or imprecise.

Why crossover analysis needs attention

In general, a crossover study compares conditions within participants, who are observed in different treatment periods. Measurements from one person are usually related rather than independent. A suitable analysis therefore needs to account for the paired or repeated nature of the observations. Ignoring that relationship can produce an inappropriate estimate of uncertainty.

Period and sequence are also relevant general features of crossover analysis. A period effect refers to a difference associated with when a measurement is made, independent of the assigned condition. A sequence effect concerns the order in which conditions are received. Carryover is a lingering effect of an earlier condition that could influence measurements in a later period. A wash-over interval is intended to separate periods, but its presence alone does not establish that carryover was absent. The registry identifies a two-period, two-sequence design and a one-month wash-over period. It does not report tests or methods for period effects, sequence effects, or carryover, or say whether the statistical model included these factors.

The record describes assessments after 3 months and after 7 months. It does not state whether the comparison used measurements at both times, a change from baseline, a period-specific value, or another definition. The baseline measurements and their role in the analysis are not reported in the registry record. These omissions prevent a reconstruction of the primary analysis from the endpoint description alone.

What is known about planning

The record includes assumptions for a planning illustration: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects defined as stated fractions of the observed effect. For non-time-to-event outcomes, such illustrations are expressed as participants per arm for a specified power. These are planning calculations, not observed power and not evidence that the trial was designed around those assumptions. Numerical planning estimates are not reported in the registry record. The sample-size justification used by the investigators is not reported in the registry record.

In general, a planning calculation depends on the chosen effect to detect, expected variability, allocation, significance level, and analysis method. For a crossover design, assumptions should also correspond to the within-participant structure. The registry’s planning description specifies some general assumptions, but does not give the investigators’ original design calculation or explain whether it accounts for the crossover design. It would not be appropriate to treat an illustration based on an observed effect as a prospective design justification.

What cannot be assessed

The registry lists one analysis, but does not give the model formula, covariates, handling of repeated observations, missing-data method, or multiplicity procedure. It does not report an intention-to-treat or per-protocol population, or clarify whether the primary analysis included all randomized participants. The primary outcome is identified as having several categories or time points, and the record does not reduce these to one comparison. These details are important because they affect how an estimate is formed and how its uncertainty should be interpreted.

As general statistical context, over-dispersion arises when variation in the data exceeds what a chosen model assumes. If present and unaccounted for, uncertainty estimates can be too small or otherwise poorly calibrated. The registry describes a continuous outcome summarized by a mean and standard error, but gives no indication that over-dispersion was assessed or relevant to the chosen analysis. The record does not report the model, so no conclusion about this issue is possible.

Overall, the registry provides the endpoint, measurement method, and broad crossover structure, but not enough detail to reproduce or evaluate the statistical analysis. The posted design information can guide questions about paired observations, periods, sequences, and endpoint timing; it cannot establish how the investigators addressed them or what the numerical result was.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is glycosylated haemoglobin, with assessments listed after 3 months and after 7 months. The registry indicates that the primary outcome has several categories or time points and was not reduced to one comparison. It does not identify which assessment was the primary inferential test, whether both time points were tested, or how any multiple comparisons were handled. A multiplicity plan is not reported in the registry record.

As general context, testing more than one outcome, time point, or comparison can increase the chance of obtaining a statistically notable result by chance. Prespecifying a primary comparison or adjusting inference for multiple tests can help control that issue. The registry lists four outcome measures and one analysis, but those counts do not reveal whether there were multiple tests, how outcomes were grouped, or what conclusions were prioritized. No statistical analysis plan or multiplicity adjustment is reported.

The record does not report the number of participants with glycosylated-haemoglobin measurements at each time point, reasons for missing measurements, or how missing outcomes were handled. It also does not identify the primary analysis population or specify whether participants were analyzed according to randomized assignment. Enrollment alone does not establish how many participants contributed to the endpoint analysis. The adverse-event denominators are reported separately and should not be treated as endpoint-analysis sample sizes.

As general context, missing-data methods can affect an estimate when the availability of measurements is related to participants’ characteristics or outcomes. Complete-case analysis, imputation, and model-based methods rely on different assumptions; none can be attributed to this trial from the registry record. The handling of withdrawals, incomplete crossover periods, and participants with data from only one period is not reported in the registry record. Without these details, the potential influence of missingness and multiplicity on the primary result cannot be assessed.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: pneumonia (0.8%).

The registry lists two safety groups. For the placebo biscuit group, 131 participants were at risk for serious adverse events, one was affected, and one death is listed. For the Kothala Himbutu biscuit group, 129 participants were at risk, no serious adverse events were listed, and no deaths were listed. The registry also names pneumonia as a serious adverse-event term and gives 0.8% for that term.

These entries are counts in the registry’s safety reporting, not a complete account of every health event experienced by participants. The record does not describe event timing, severity details beyond the serious-event classification, relatedness to study biscuits, or how events were collected. It does not establish whether the serious event and death listed in the placebo group refer to the same participant or event. That relationship is not reported in the registry record.

The group denominators differ and are not the same as the total enrollment. They describe participants at risk in the safety entries, not necessarily the population analyzed for glycosylated haemoglobin. The posted safety counts do not by themselves establish a comparative safety effect, and the small event counts offer limited precision. Non-serious adverse-event details and fuller liver and renal outcome results are not reported in the registry record. These figures should be read as the specific serious-event entries recorded, not as proof that no other events occurred.

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

This registry record identifies a randomized, placebo-controlled crossover study of a biscuit containing Kothala Himbutu extract in people with type 2 diabetes. It specifies glycosylated haemoglobin as the primary endpoint, describes the laboratory method, and lists assessments after 3 months and after 7 months. It also records the intended comparison with an identical biscuit without the extract and notes a one-month wash-over interval.

Those details explain what the investigators set out to examine. They do not reveal the observed result. The registry record does not report glycosylated-haemoglobin means, an estimated contrast, a confidence interval, or a p-value. It also does not select one primary comparison from the listed time points. Therefore, no conclusion about the direction, size, or statistical precision of the primary result can be drawn from the posted record.

As general context, a statistically estimated difference is only one part of interpretation. Its precision, the analysis assumptions, the completeness of outcome data, and the clinical relevance of the measure all matter. Glycosylated haemoglobin is a laboratory measure of glycaemia; it does not represent every aspect of diabetes or participants’ overall health. The registry’s description of centralized testing and NGSP standardization speaks to measurement procedures, not to the size or importance of a treatment effect.

The record also lists serious adverse-event entries and liver and renal adverse effects as secondary outcomes. The reported safety counts are limited to the listed groups and do not establish a causal relationship with either biscuit. Further details about adverse-event collection and the secondary outcome results are not reported in the registry record.

In short, the record supports a description of the trial question and design, but not a claim that one biscuit produced a particular glycosylated-haemoglobin result or safety profile. A completed status indicates the trial is marked completed in the registry; it does not fill in missing outcome estimates or analytical details.

13. Why This Trial Matters Statistically

This trial is statistically interesting because its crossover structure changes what a valid comparison requires. In a parallel-group study, the main comparison is between different groups of participants. In a crossover study, participants may contribute measurements under more than one condition, so observations from the same participant are related. As general statistical context, accounting for this within-participant relationship can improve the efficiency of a comparison, but the analysis must reflect the design.

The registry describes two periods and two sequences, with a one-month wash-over interval. That makes questions about period, sequence, and carryover relevant to understanding the estimate. The record does not say how these factors were incorporated into the analysis or whether carryover was assessed. This is a useful reminder that a design label alone does not tell readers whether the analytical model respected the design’s structure.

The endpoint description also illustrates the distinction between measurement detail and statistical reporting. The laboratory method and NGSP standardization are stated, and the outcome is summarized as a mean with standard error. Yet the numerical outcome values and treatment contrast are absent. Without estimates and uncertainty, a reader cannot judge the magnitude or precision of the result, even when the endpoint and assay are described.

Finally, the record illustrates why outcome timing and multiplicity matter. Glycosylated haemoglobin was assessed at two stated times, but the registry does not identify one as the definitive comparison or report how multiple time points were handled. That ambiguity limits interpretation independently of the crossover design. Together, these features show why statistical appraisal needs the analysis plan and numerical estimates as well as the trial’s headline design.

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 registry record leaves several trial-specific details unresolved. It does not report numerical glycosylated-haemoglobin results or a treatment-effect estimate, so the primary finding cannot be assessed for magnitude or precision. Although the outcome is listed at two assessment times, the record does not identify a single primary comparison. A confidence interval, p-value, and analysis model are not reported.

The record describes a two-period, two-sequence crossover trial and a one-month wash-over period, but does not state how participants were assigned to sequences, how many completed each period, or how the analysis addressed within-participant correlation, period effects, sequence effects, or carryover. It does not report the baseline outcome values or explain whether the primary analysis used change from baseline or another measure.

Enrollment is 133, while the safety entries list different numbers at risk for the two groups. The number contributing to each primary endpoint assessment, exclusions, withdrawals, and missing-data methods are not reported in the registry record. The safety denominators cannot resolve these gaps because they describe a different reporting context.

There is also an unresolved discrepancy between the official title’s triple-blind wording and the structured masking entry of quadruple. The registry does not explain which roles were masked. The active biscuit’s dose and duration are stated, while the placebo arm description does not separately state dose or duration. The record lists liver and renal adverse-effect outcomes but does not provide their results or collection methods. Finally, the investigators’ sample-size justification, analysis plan, multiplicity approach, and protocol deviations are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study — NCT02290925.
• Registry record last updated 2019-05-14; status last verified 2019-03.
• Results first posted 2019-03-27.
• 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

NCT02290925 is listed as a completed, randomized phase 3 crossover trial sponsored by Rajarata University, Sri Lanka. It enrolled 133 people with type 2 diabetes mellitus. The record gives a start date of 2014-05 and a primary completion date of 2017-04.

The study compared a Kothala Himbutu (Salacia reticulata) extract biscuit with an identical placebo biscuit. The primary endpoint was glycosylated haemoglobin, measured after 3 months and after 7 months, with a one-month wash-over period stated for the crossover design. The laboratory method is described as ion exchange high performance liquid chromatography standardized to NGSP.

The registry does not report primary outcome values, an estimated comparison, or its uncertainty. It lists liver and renal adverse-effect outcomes and records serious-event entries in both groups. The analysis details, endpoint missingness, and explanation for the difference between triple-blind and quadruple masking descriptions are not reported in the registry record.