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

M Rajanna; B Bharathi; B R Shivakumar; M Deepak; D'Souza Prashanth; D Prabakaran; T Vijayabhaskar; B Arun

doi:10.1016/j.jaim.2021.06.004

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

J Ayurveda Integr Med. 2021 Jul-Sep;12(3):529-534. doi: 10.1016/j.jaim.2021.06.004. Epub 2021 Aug 8.

Authors

M Rajanna¹, B Bharathi², B R Shivakumar¹, M Deepak³, D'Souza Prashanth³, D Prabakaran⁴, T Vijayabhaskar⁴, B Arun⁴

Affiliations

¹ Surya Medical Centre, Bangalore, 560084, India.
² Natural Remedies Pvt Ltd, Bangalore, 560100, India. Electronic address: bharathi.b@naturalremedy.com.
³ Natural Remedies Pvt Ltd, Bangalore, 560100, India.
⁴ In Vitro Research Solutions (iVRS) Pvt Ltd, Bangalore, 560092, India.

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.

Keywords: Andrographis paniculata; Immunity; Interferon gamma; Interleukin-2; Interleukin-4; T cells; T helper cells.