Immunomodulatory effects of Andrographis paniculata extract in healthy adults - An open-label study.

Abstract Background Andrographis paniculata (Burm.f.) Nees has been well-researched for its immunomodulatory effects. Objective(s) To investigate the immunomodulatory effects of standardized A. paniculata extract (SAPE) in healthy adults. Materials and methods The study was an open-label, single-centre study conducted for 30 days. Thirty participants with absolute lymphocyte counts of 1000–4000 cells/mm3 were enrolled and were instructed to ingest 200 mg of SAPE daily for 30 days. The participants visited the clinic at baseline, and days 3, 7, and 30. Immune cells such as NK cell (CD3-CD16+CD56+), T cells (CD3+), T helper cells (CD3+CD4+), T cytotoxic cells (CD3+CD8+) were measured using flow cytometry. Serum cytokines that include interferon gamma (IFN-γ), interleukin-4 (IL-4), interleukin-2 (IL-2), interleukin-12 (IL-12), and tumor necrosis factor alpha (TNF-α) were measured using ELISA. The SAPE used in this study was a standardized proprietary extract (AP-Bio®/KalmCold®) developed from the leaf extracts of A. paniculata. Results SAPE increased T cells, T helper cells and significantly increased IFN-γ, IL-4, and decreased IL-2 at day 30. A subgroup analysis of participants with absolute lymphocyte counts of 1000–3000 cells/mm3 indicated that there is a significant increase in the T cells, T helper cells at day 7 and 30 and significant increase in IFN-γ, IL-4 and decrease in IL-2 at day 30. There was no treatment related adverse effects following SAPE intake for 30 days. Conclusion Supplementation of SAPE resulted in immunomodulatory effects evidenced by its effects on immune cells and cytokines and it was found to be safe and tolerable.