The ingredient, called AP Bio, is a standardized extract of Andrographis paniculata. The botanical is an herbaceous plant found throughout Southeast Asia and India.
A. paniculata has been known as the ‘king of bitters’ and is used in traditional medicine systems in the region, including in India, China, Thailand and the Philippines. It has been used in connection with a variety of ailments including the common cold, respiratory infections, urinary tract infections and indigestion. The plant has a complex chemistry with an array of diterpenoids, flavonoids and other polyphenols.
The recent study on Natural Remedies’ ingredient was published in the Journal of Ayurveda and Integrative Medicine. It was the work of experts associated with a medical center and a contract research organization in Bangalore, as well as two Natural Remedies employees. The company funded the research.
The researchers noted that AP-Bio, which is also marketed under the name KalmCold, is an extract of the plant’s leaves. The extract’s specifications are in concord with the USP monograph on the plant, the authors said.
Clinical research abundant, but evidence on cellular mechanisms lacking
The researchers noted that 33 separate clinical studies can be referenced to show the effects of A. paniculata extracts in the treatment of respiratory infections caused by seasonal viruses. Nevertheless, the authors said there is a paucity of evidence for the action of extracts of the plant on the cellular level in human models.
To test the precise action of the extract on the immune system of health subjects the researchers set up an open label trial. They recruited 30 healthy individuals in Bangalore, India. They were instructed to take 200 mg of the test extract in two separate 100 mg does, morning and evening, for 30 days. They were instructed to maintain their standard lifestyle and diet during the test period. The extract was contained in standard capsules. The researchers reported about 95% average compliance with the supplementation protocol.
The subjects visiting the lab during the screening process and again at days 3, 7 and 30.
The primary outcome the researchers measured was the change in the NK cell (CD3−CD16+CD56+) counts. The secondary outcome measures included change in the total T cells (CD3+ cells), CD4+ T cells, CD8+ T cells counts and changes in various cytokines such as interferon gamma (IFN-γ), interleukin-4 (IL-4) and interleukin-2 (IL-2).
Secondary measures show greatest result
The results shed some light on how AP-Bio affects the immune system, and inlcudied some surprises. The researchers found that the test material did not move the needle on the primary measure, it had some beneficial effects on the secondary measures.
“This was the first pilot study investigating the immunomodulatory effects of SAPE (standardized Andrographis paniculata extract) in healthy adults. The data presented here suggest that SAPE supplementation increases immune cells such as T cells, T helper cells and IFN-γ, IL-4 production, but does not increase the NK cell counts. Furthermore, SAPE supplementation is not associated with any significant adverse effects,” they concluded.
Source: Journal of Ayurveda and Integrative Medicine
DOI: 10.1016/j.jaim.2021.06.004
Immunomodulatory effects of Andrographis paniculata extract in healthy adults - An open-label study
Authors: Rajanna M, et al.
