(P18-013-25) An Herbal Blend of Terminalia chebula and Withania somnifera Extracts Reduces the Symptom Severity and Incidence of Upper Respiratory Tract Infection in Healthy Adults

Objectives: Terminalia chebula (Haritaki) and Withania somnifera (Ashwagandha) are important botanicals used in Ayurveda for a variety of health benefits. A standardized composition of extracts from T. chebula fruit and W. somnifera roots (LN20189) has been shown clinically to enhance immune function. This randomized, double-blinded, placebo-controlled clinical trial aimed to assess the efficacy of LN20189 on the incidence and symptom severity of upper respiratory tract infection (URTI), quality of life, and immunity-related biomarkers.

Methods: A total of 120 healthy men and women, aged 30-60, with a BMI of 22-29.9 kg/m² and a self-perceived poor immune status were randomly allocated into one of three groups: 250 mg LN20189 (LN-250), 500 mg LN20189 (LN-500), or placebo (PLA). Subjects consumed supplements and logged URTI symptoms using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) daily for 12 weeks. The Psychological General Well-being Index (PGWBI) was utilized to measure health- and mood-related quality of life outcomes. Key biomarkers of immune function were also assessed.

Results: WURSS-24 Global, Symptom, and Quality of Life scores assessed during URTI incidence demonstrated main treatment effects (p < 0.001), and between-group comparisons indicated LN-500 and LN-250 supplementation improved these scores compared to PLA (p < 0.01). Only LN-500 supplemented subjects demonstrated reduced URTI incidence count (p < 0.01), but both LN-500 and LN-250 reduced the severity of nasal, throat, and systemic URTI symptoms vs. PLA (p < 0.01). Compared to PLA, both LN20189-supplemented groups improved PGWBI scores (p < 0.01 on days 21, 42, and 84). Several biomarkers improved with supplementation; total white blood cell count, total immunoglobulin G, and total antioxidant capacity increased while serum interleukin-4 levels decreased in LN-250 and LN-500 compared to PLA (p < 0.05). All hematology and clinical biochemistry measures were within normal ranges.

Conclusions: Daily LN20189 supplementation improved WURSS-24 Global, Symptom, and Quality of Life scores; psychological health and well-being; and key biomarkers of immune function. Both LN-250 and LN-500 decreased URTI symptom severity, and LN-500 reduced URTI incidence count over 12 weeks in healthy adults.

Funding Sources: Laila Nutraceuticals, Vijayawada, India