Indus Biotech Pvt Ltd.

Background: Polyphenols-based standardized cinnamon (Cinnamomum zeylanicum) bark extract (IND02) demonstrated efficacy against allergic rhinitis in animal models and human clin. study.Objectives: To assess the acute and subacute intranasal toxicity of the IND02 nasal solution (IND02-NS).Methods: Acute and 28-days subacute toxicity using the intranasal route of administration of IND02-NS was evaluated using Wistar rats as per Organization for Economic Co-operation and Development guidelines.For acute intranasal toxicity study, a single dose of 100 μg/rat/day was administered in five male and female rats and observed for the incidence of mortality and signs of toxicity for 14 days.For a 28-days subacute intranasal toxicity study, doses of 20, 50, and 100 μg/rat/day were administered to a group of five male and female rats.Results: The IND02-NS did not show mortality or treatment-related adverse signs during acute (limit dose of 100 μg/rat/day) and subacute intranasal (28-days repeated dose of 20, 50, and 100 μg/rat/day with 14 days of reversal period) administration.The IND02-NS showed a maximum tolerated dose greater than 100 μg/rat during the acute intranasal toxicity study.The no-observed adverse effect level of IND02-NS was 100 μg/rat/day in rats during the subacute intranasal toxicity study.Conclusion: IND02-NS was found safe at 100 μg/rat/day during acute and subacute (28 days repeated dose) for nasal administration in rats.

The aim of the study was to assess the safety and efficacy of a nasal spray containing a polyphenol-rich standardized extract of cinnamon bark (Cinnamomum zeylanicum) (IND02) for the treatment of seasonal allergic rhinitis (SAR).

This study was a randomized, double-blind, placebo-controlled study conducted in otherwise healthy men and women, aged between 18 and 75 years old, who were experiencing acute SAR symptoms. Participants were randomized in a 1:1 ratio to a nasal spray containing either IND02 (100 μg/100 μL) or matching placebo in each nostril, twice a day, for seven days.

The IND02 group showed a statistically and clinically significant reduction in total RQLQ and the sub-domains; activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function. There was a significant reduction in the total daily symptom score and sub-domains of total day-time nasal, total day-time eye and total night-time nasal symptoms scores, and total work impairment and regular activity impairment in the IND02 group compared with the placebo group after treatment. The laboratory clinical parameters remained within healthy normal reference range.

The use of a nasal spray of a standardized extract of cinnamon bark (IND02) over seven days reduced symptom severity and improved quality of life, work productivity and regular daily activities in participants experiencing SAR.

Fenugreek (Trigonella foenum graecum) seed extract is a bioactive ingredient of many food supplements. Hence, there is a need for systematic assessment of the quality of published toxicological studies for its use in human health, hazard consideration, and risk assessment. The aim of the present investigation was to determine the reliability of published toxicological studies of fenugreek seed by using ToxRTool (Toxicological data reliability assessment tool). A comprehensive systematic literature search was conducted in PubMed, EMBASE, Cochrane Library, CPCI-S, ICTRP, Ovid, and Google Scholar till October 2018. Each identified study was evaluated for its quality using the ToxRTool with outcomes such as combined score, weighted score, and reliability category by three independent raters. Correlations of various criteria groups with the combined score were evaluated by Pearson correlation and Kendall rank correlation coefficient. Inter-rater consistency was measured by Cronbach's alpha coefficient. The database searches initially yielded 436 results, of which 391 (89.67%) studies were "not assignable". The remaining 45 studies were included for quantitative analysis by ToxRTool. Based on the weighted score, 17 in-vivo, and 3 in-vitro studies were determined to be "Reliable Without Restriction" which were conducted according to international guidelines such as GLP. These studies have a significant difference (p < 0.05) for the combined and weighted score as compared to non-GLP studies. Remaining 28 in-vivo and 2 in-vitro studies were determined to be "Not Reliable." The GLP studies conducted with "identified study material" have a significant difference (p < 0.0001) between combined and weighted score as compared to studies which used "non-identified study material". For criteria group of ToxRTool I, III and V, the Pearson correlation with the combined score was found to be 0.875, 0.734 and 0.905, respectively and Kendall rank correlation coefficient was found to be 0.764, 0.551 and 0.752, respectively. Cronbach's alpha coefficient for combined score and weighted score were 0.920 and 0.887, respectively. In conclusion, the ToxRTool was found useful to identify seventeen toxicity studies of fenugreek seeds as "Reliable without Restrictions". These studies showed a broad margin of safety for the standardized extract of fenugreek seeds and can form a basis for toxicological risk assessment with reasonable certainty.