Efficacy and safety of AP-Bio®(KalmCold®) in participants with uncomplicated upper respiratory tract viral infection (common cold) − A phase III, double-blind, parallel group, randomized placebo-controlled trial

Raj, Jeffrey Pradeep; Maurya, Miteshkumar; Nair, Nayana; Marfatia, Hetal; Hadaye, Rujuta S; Gogtay, Nithya J

doi:10.1016/j.ctim.2023.102934

Cited by 2 publications

(3 citation statements)

References 14 publications

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“…AP‐Bio®/KalmCold® was reported to support immunity (Rajanna et al, 2021) and reduce symptoms of common cold, in human clinical studies (Raj et al, 2023; Saxena et al, 2010). In these clinical studies, Andrographis was well‐tolerated.…”

Section: Discussionmentioning

confidence: 99%

“…A. paniculata extract was administered orally to G2, G3, and G4/G4R at doses of 300, 600, and 900 mg/kg b.w., respectively, per day for 90 days. The selected maximum dose is higher than 20‐fold of the maximum recommended human equivalent dose of the test substance, which is 400 mg per day used in the management of the symptoms of common cold (Raj et al, 2023). Animals in G1 and G1R were administered orally with vehicle (1% sodium CMC) for 90 days.…”

Section: Methodsmentioning

confidence: 99%

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Toxicological safety assessment of AP‐Bio®, a standardized extract of Andrographis paniculata in Sprague Dawley rats

Murugan

Bethapudi

Rao³

et al. 2023

J of Applied Toxicology

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Andrographis paniculata, commonly known as green chiretta, is a traditionally used plant in India, China, and Southeast Asian countries for its varied health benefits including immune health. The objective of the present study was to assess the safety of AP‐Bio®, a standardized A. paniculata extract in Sprague Dawley rats by following the Organisation for Economic Cooperation and Development (OECD) test guidelines of acute and 90‐day repeated dose sub‐chronic toxicity studies. AP‐Bio® did not show any treatment‐related clinical signs of toxicity or mortality during the 14‐day observation period in animals tested in the single‐dose acute oral toxicity study up to a dose of 5000 mg/kg body weight. In the 90‐day repeated dose sub‐chronic oral toxicity study, no treatment‐related adverse clinical signs were observed in any of the treated groups (300, 600, and 900 mg/kg). All treated animals showed usual weight gain and comparable feed intake. The ophthalmoscope examination did not reveal any abnormalities. Also, no toxicologically significant changes were observed in urinalysis, hematology, and blood chemistry parameters. Absolute organ weights and relative organ weights of vital organs did not differ significantly compared to control. Gross and histopathological findings did not show any remarkable and treatment‐related changes. Results of the safety evaluation showed the median lethal dose (LD50) of AP‐Bio® was found to be more than 5000 mg/kg rat body weight and the no observed adverse effect level (NOAEL) of AP‐Bio® was found to be 900 mg/kg rat body weight.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Toxicological safety assessment of AP‐Bio®, a standardized extract of Andrographis paniculata in Sprague Dawley rats

Murugan

Bethapudi

Rao³

et al. 2023

J of Applied Toxicology

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“…SEAP contains ˃33% diterpene lactones with ˃30.0% w/w of andrographolide as analyzed by HPLC. As per the USP, the 14-deoxy-11,12-didehydroandrographolide content is not >15% of the total diterpene lactones (Raj et al, 2023).…”

Section: Methodsmentioning

confidence: 96%

Assessment of Immunomodulatory Activity of AP-Bio® (KalmCold®), a Standardized Extract of Andrographis paniculata Using in vivo and ex vivo Models

Chalichem,

Nabhan,

Bethapudi

et al. 2024

Pharmacognosy Magazine

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Background: Andrographis paniculata (Burm. f.) Nees is a well-recognized medicinal plant known for its benefits against a multitude of ailments. The intent of the present study was to evaluate the effect of a standardized extract of A. paniculata on innate immunity. Materials and Methods: Phagocytic activity was measured in terms of phagocytic index using carbon clearance methodology in mice. In another experiment, NK cells (effector cells) were isolated from the mouse spleen after the dosing period, and NK cells-mediated lysis of target cells (YAC-1 cells) were determined using an MTT assay. Results: The phagocytic index and NK cell activity were found to be significantly ( p < 0.05) different in the treated group compared to the control group in the tested animal models at a dose of 41 mg/kg. Conclusion: The results suggest the potential of A. paniculata to enhance innate immunity.

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Efficacy and safety of AP-Bio®(KalmCold®) in participants with uncomplicated upper respiratory tract viral infection (common cold) − A phase III, double-blind, parallel group, randomized placebo-controlled trial

Cited by 2 publications

References 14 publications

Toxicological safety assessment of AP‐Bio®, a standardized extract of Andrographis paniculata in Sprague Dawley rats

Toxicological safety assessment of AP‐Bio®, a standardized extract of Andrographis paniculata in Sprague Dawley rats

Assessment of Immunomodulatory Activity of AP-Bio® (KalmCold®), a Standardized Extract of Andrographis paniculata Using in vivo and ex vivo Models

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