Editor's Note
Andrographis paniculata (Burm.f.) Nees is a plant in the Acanthaceae family, found throughout tropical and sub-tropical Asia, Southeast Asia, and India. A. paniculata is widely used in traditional medicine in India, China, Thailand, Bangladesh, Pakistan, Hong Kong, Philippines, Malaysia, and Indonesia for various ailments such as common cold, respiratory infections, pneumonia, lung infections, urinary tract infections, indigestion, liver diseases, and skin infections. There are thirty-three randomized controlled trials involving 7175 patients that support the effectiveness of A. paniculata (alone or as an herbal mixture) in respiratory tract infections typically caused by seasonal viruses. Also, several animal and cell-based studies indicate broad spectrum anti-viral activity of the plant.  While evidence exists for immunomodulatory effects of A. paniculata in cell and animal systems, there is a paucity of clinical evidence on the effects of A. paniculata on immune system in healthy individuals. Hence, the current pilot open-label, single-arm clinical study was conducted to evaluate whether a standardized A. paniculata leaf extract (SAPE) would modulate the immune functions in healthy adults.

Participants recruited were male and female aged between 18 and 60 years with a body mass index of 18–30 kg/m2who are healthy as determined by medical history, physical examination, and clinical judgement by the investigators. 30 participants were recruited who took investigational product (IP) for 30 days. Participants were invited to the clinic before starting the treatment (day 0) and thrice at day 3, 7, and 30 after IP ingestion. The primary outcome measures of the study were the change in the NK cell(CD3−CD16+CD56+) counts. The secondary outcome measures included the following immune parameters: change in the total T cells (CD3+ cells), CD4+ T cells, CD8+ T cells counts, the changes in the cytokines such as interferon gamma (IFN-γ), interleukin-4 (IL-4), interleukin-2 (IL-2), interleukin-12 (IL-12), and tumour necrosis factor alpha (TNF α). SAPE administration for 30 days increased the lymphocyte counts and modulated the cytokine production which suggests that it modulates the immune function in healthy people. In addition, it was found to be safe and tolerable.
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.
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