(P08-019-23) An Herbal Blend of Boswellia serrata and Aegele Marmelos, With and Without Glycyrrhiza glabra, Improves Functional Respiratory Outcomes and Indices of Well-Being

Objectives: This randomized, double-blind, placebo-controlled clinical trial assessed the efficacy of two herbal blends on respiratory performance, walking capacity, and quality of life measures in healthy adults with self-reported sensitivity to air pollution.

Methods: A total of 105 men and women, aged 20-65 and with a BMI of 22-29.9 kg/m2, were randomly assigned to three groups provided with once-per-day oral supplementation for 42 days: Boswellia Serrata + Aegele Marmelosa 200 mg (ALV); Boswellia Serrata + Aegele Marmalos 200 mg + 200 mg Glycyrrhiza Glaba (ALV+); or a matched placebo (PLA). Outcome measures were assessed at baseline, day 21, and day 42. Forced expiratory volume of exhalation (FEV-1) and forced vital capacity (FVC) were measured to assess respiratory function, while aerobic capacity was measured through the six-minute walking test (SMWT). The Wisconsin Upper Respiratory Symptom Survey (WURSS-21) and Psychological General Well-being Index (PGWBI) were utilized to indicate health- and mood-related quality of life outcomes. Additionally, serum cytokine levels including Interleukin 8 (IL-8), Interleukin 4 (IL-4), and interferon gamma (IFNγ), plus CD4+ and CD8+ T-cells were assessed at baseline and day 42.

Results: Repeated measure ANOVA indicated a significant (p < 0.001) group x time interaction for FEV-1, FVC, and SMWT, while between group comparisons illustrated both ALV and ALV+ significantly (p < 0.05) improved these measures compared to PLA at both 21 and 42 days. Likewise, supplemented subjects demonstrated significantly (p < 0.001) improved scores on WURSS-21 and PGWBI. Compared to PLA, ALV and ALV+ significantly (p < 0.001) reduced serum levels of IL-4 and IL-8, but increased IFNγ and IFNγ:IL-4 ratios by end of study. In both active groups the CD4+/CD8+ ratio did not differ from PLA. All vital signs and safety parameters were without clinically significant aberrations.

Conclusions: Overall, both herbal blends, ALV and ALV+, appear to be well-tolerated supplements that increased measures of respiratory function, exercise capacity, and associated quality of life indices after 42 days of daily use in healthy adults with reported sensitivity to air pollution. Supplementation also improved biomarkers typically associated with lung inflammation.

Funding Sources: Laila Nutraceuticals