Evaluation of the Immunomodulatory Effect of an Organometallic Formulation of Laghumalini Vasant by using Cell Culture: A Research Protocol

Abstract

Introduction: The immune system serves as the body’s defence mechanism and aids in maintaining homeostasis by defending against infections and foreign bodies. Immunomodulation, either through stimulation or suppression, is useful in disease prevention. During Coronavirus Disease-2019 (COVID-19) pandemic, significant immunity and preventive measures were considered of prime importance. Need of the Study: During the pandemic, an organometallic formulation, Laghumalini Vasant (LMV), was prescribed by AYUSH advisory to control mild to moderate fever. Under the Indian system of medicine, it is recommended for pyrexia, diarrhoea, piles, ophthalmic diseases and diabetes mellitus. While many review articles claim that LMV is an immunomodulator, this has not been evident. LMV is rich in zinc. Hence, it might affect immunity. Considering this, the study is undertaken to assess the immunomodulatory effect of LMV through cell line experiments. The LMV will be assessed for Immunoglobulin G (IgG), Immunoglobulin M (IgM), Adenosine Deaminase (ADA) and Cytokinase. If evidence of the immunomodulatory effect is generated, this drug could be prescribed to patients for immunomodulation. Aim: To evaluate the immunomodulatory effect of the organometallic formulation, LMV, using cell culture. Materials and Methods: An in-vitro experimental study will be conducted at Central India Institute of Medical Sciences (CIIMS), Nagpur, Maharashtra, India from November 2024 to January 2026. The immunomodulatory effect will be assessed by Lipopolysaccharide (LPS) and Phytohemagglutinin (PHA)-induced immune deregulation in the cell culture model system via assays for IgG, IgM, ADA and Interleukins. Statistical analysis will be performed using MedCalc software (version 10). Each experiment will be carried out in triplicate and repeated three times to ensure data reliability. Results will be expressed as Mean±SD. The experimental and the control group will be compared using a t-test. A p-value <0.05 will be considered statistically significant.

Keywords

• adenosine deaminase
• cytokinase
• immunoglobulin g
• immunoglobulin m
• immunomodulation