The Virulina® formulation has been formulated after extensive literature survey on the Indian medicinal plants and their reported traditional use and applications in reference to Ayurvedic text books and formularies, and also based on past experimental data reported on pharmacological activities relevant to anti-viral and immunomodulatory activities. Thus the selection of the medicinal plants, their parts or extracts is based on evidences reported through the data.

Anti-Viral activity of naturally occurring substances

Tannic acid shows high antiviral effectiveness. It has been studied as a component of extracts isolated from natural sources, but also as a pure compound. Its antiviral activity is based on the virus cell membrane adsorption, which results in inhibiting the virus activity and the ability to attack human cells.Flavonoids are natural biomolecules that are known to be effective antivirals. These biomolecules can act at different stages of viral infection, particularly at the molecular level to inhibit viral growth.

In vitro phagocytosis test:

The results of the in vitro PMN function test showed a significant increase in the percentage phagocytosis and phagocytic index for successive methanol and water extracts. This indicates that Virulina® enhances the phagocytic efficacy of the PMN cells at 100 mg/ml by causing more engulfment of the Candida cells versus control, thereby stimulating a non-specific immune response.

Acute toxicity study:

The results of the acute toxicity study indicated that the LD 50 of VLR-NS was more than 2000 mg/Kg body weight.

Hypersensitivity reaction:

These results indicate that Virulina® has a greater effect on the early hypersensitivity reaction and a less pronounced effect on the delayed hypersensitivity reaction.

The results of in vivo animal studies showed an increase in the early and delayed hypersensitivity reaction to SRBC at doses of 200 mg/kg and 500 mg/kg. This indicated the stimulatory effect of Virulina® on chemotaxis dependent leucocyte migration.

Hemagglutination reaction:
Per oral administration of Virulina® (50, 100, 200 and 500mg/ kg) for five days produced a dose related increase in the antibody titer in rats.

Antibody molecules which are secreted by plasma cells mediate the humoral immune response. Virulina showed an increase in the hemagglutination titer at doses of 100 mg/kg and 200 mg/kg in animal studies. This augmentation of the humoral response to SRBC indicated an enhanced responsiveness of the macrophages, T and B lymphocyte subsets involved in antibody synthesis.

Immunomodulatory activity :

Virulina® probably stimulates lymphocyte proliferation, which in turn leads to production of cytokines that activate other immune cells such as Beta cells, antigen-presenting cells and other T cells.
Virulina® was found to have a significant immunostimulant activity on both the specific and non-specific immune mechanisms.

Evaluation of Immunostimulant activity and inhibition of cytokine storm activity of novel formulation Virulina® :

Drastic reduction in cytokine production was observed in both low dose and high dose Virulina groups. Administration of (Endotoxin Lipopolysaccharide) LPS (10 mg/kg, i.p.) in rats (animal model) led to overproduction of inflammatory markers (cytokine storm). Virulina® was used as the Immunostimulant and anti-inflammatory drug. It inhibited inflammation and oxidative stress and in turn prevented lung fibrosis, septicemia and multi-organ dysfunction in test animals.

Animal study results clearly show strong suppression of inflammatory markers viz. IL-1beta, IL-6 and TNF-α in the test group receiving Virulina® compared to the group which did not receive Virulina®.
Significant suppression of IL-6 and HS-CRP during clinical trial was also observed in human patients diagnosed with Covid-19.

Virulina® significantly reduced excess production of IL-6, TNF-α, MCP-1, interferon gamma-induced protein-10 (IP-10), regulated on activation, normal T cell expressed and secreted (RANTES), leukemia inhibitory factor (LIF), lipopolysaccharide-induced CXC chemokine (LIX), granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and vascular endothelial growth factor (VEGF) in poly(I:C)-induced RAW 264.7 mouse macrophages