Analysis of Immunomodulatory Effects of Herbal Formulation by Random Clinical Trial Against Post Covid 19 Vaccination


Authors : Suresh B. Patankar; Anupama Gorde; Sagar Patankar; Rajesh Raje; Chadrashekhar Gillurkar; Pranjal Ausekar; Gaurav Patil

Volume/Issue : Volume 8 - 2023, Issue 4 - April

Google Scholar : https://bit.ly/43uxUln

Scribd : https://bit.ly/40EEqmY

DOI : https://doi.org/10.5281/zenodo.7866294

Abstract : Traditional medicine has demonstrated its efficacy in treating a vast array of ailments, including infectious ones, over the years. Because of their immunomodulatory and other pharmacological actions, polyherbal formulations are suitable for COVID-19 infection prevention. After two Covaxin doses, human immunological markers were shown to diminish a few days later. This study evaluated the effect of Abayakasthaa plus (IP) capsules on the immune levels of volunteers who had two Covaxin injections. The IP is a mixture of around 11 indigenous plant extracts that have been demonstrated to possess immune-boosting properties independently. In a multispecialty hospital in central India, 30 volunteers were randomised into two groups of 15 each for a pilot randomised experiment for 28 days. Four immunological indicators (IgG) & Covaxin Dose (CD3+, CD4+, and CD8+ cell count) were evaluated on the 0th and 28th day following immunisation using blood samples. For independent samples, the t-test helped compare mean biomarker values between two groups, while the paired ttest helped compare marker values in follow-ups.At day 28, the mean (geometric) concentration of IgG antibodies in the test group was substantially greater than in the placebo group (p=0.04). Although the concentration of the marker reduced considerably in the placebo group (p = 0.021), it stayed virtually constant in the test group (p = 0.824). On day 28, other metrics were comparable and showed negligible differences between groups. The results of a preliminary study show that herbal preparations increase COVID-19 vaccination-induced immunogenicity for an extended length of time. To justify the results, more research with bigger cohorts is necessary.

Keywords : COVID-19 vaccination, Clinical trial,Herbal formulation, Immunomodulation.

Traditional medicine has demonstrated its efficacy in treating a vast array of ailments, including infectious ones, over the years. Because of their immunomodulatory and other pharmacological actions, polyherbal formulations are suitable for COVID-19 infection prevention. After two Covaxin doses, human immunological markers were shown to diminish a few days later. This study evaluated the effect of Abayakasthaa plus (IP) capsules on the immune levels of volunteers who had two Covaxin injections. The IP is a mixture of around 11 indigenous plant extracts that have been demonstrated to possess immune-boosting properties independently. In a multispecialty hospital in central India, 30 volunteers were randomised into two groups of 15 each for a pilot randomised experiment for 28 days. Four immunological indicators (IgG) & Covaxin Dose (CD3+, CD4+, and CD8+ cell count) were evaluated on the 0th and 28th day following immunisation using blood samples. For independent samples, the t-test helped compare mean biomarker values between two groups, while the paired ttest helped compare marker values in follow-ups.At day 28, the mean (geometric) concentration of IgG antibodies in the test group was substantially greater than in the placebo group (p=0.04). Although the concentration of the marker reduced considerably in the placebo group (p = 0.021), it stayed virtually constant in the test group (p = 0.824). On day 28, other metrics were comparable and showed negligible differences between groups. The results of a preliminary study show that herbal preparations increase COVID-19 vaccination-induced immunogenicity for an extended length of time. To justify the results, more research with bigger cohorts is necessary.

Keywords : COVID-19 vaccination, Clinical trial,Herbal formulation, Immunomodulation.

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