Randomised, double-blind, placebo-controlled pilot clinical trial of jackfruit seed extract formulation (JaSE) for allergic rhinitis treatment

Allergic rhinitis (AR), a chronic inflammatory disease associated with comorbidities, adversely affects life’s quality, productivity and increases financial healthcare burden. Herbal medicines are emerging for AR treatment. The presence of two immunomodulatory lectins (jacalin and artinM) in jackfruit ( Artocarpus heterophyllus ) seeds suggests a probable therapeutic potential of jackfruit seed extract in AR management. A double-blind, placebo-controlled pilot trial of jackfruit seed extract formulation (JaSE) was conducted in 60 AR patients to assess its AR treatment efficacy by evaluating changes in AR symptoms (score-based) over 15 days of treatment. The study was approved by the Institutional Ethics Review Committee and was registered with CTRI (CTRI/2023/08/056311). Out of 60 patients enrolled, 53 completed the trial. No adverse events were reported throughout the study. Post-treatment, both the JaSE and placebo (saline) groups demonstrated statistically significant reduction in AR symptoms. The potential of JaSE in relieving AR symptoms was observed, though non-significant as compared to placebo. Absence of statistically significant difference between two treatment groups may be attributed to the placebo effect and small sample size. Expanding sample size and conducting adequately powered clinical trials in future will be essential to accurately assess the efficacy of the novel candidate JaSE in AR management.