From the clinical researcher’s desk

Introduction

Mulmina® holds the prestige of being the world’s first aseptic Tetra Pak based antioxidant, immune and mind booster to fight common clinical problems of oxidative stress, immune stress and mental stress. It comes as a tasty refreshing blend of immune nutrition with powerful antioxidants and mesonutrients. 

Objective

This study evaluated the immune-boosting activity of Mulmina® Mango health drink in asymptomatic, mildly symptomatic COVID-19 patients and healthcare workers posted to COVID wards. 

Study design and method 

• Study type: It was a Prospective, open-label, three-arm, single-centre, controlled study. It enrolled 40 patients to receive Mulmina® Mango twice a day and 40 patients to receive Standard of care. The safety and efficacy assessments were performed on days 0, 14 and day 28.
• Serum immune biomarkers and serum antioxidant markers were estimated in plasma samples using ELISA kits.

Key observations: 

Efficacy 

Serum immune biomarkers 

• Serum amyloid A (SAA):  Increased SAA levels in COVID-19 patients is associated with a likeliness of condition worsening. SAA increase was observed in all the enrolled patients and was noted statistically significant between both groups.
• Cytokine interleukin 4: The Mulmina® treated group did not show any significant increase in the levels of cytokine interleukin 4 (IL-4) from day 0 to day 28 of treatment.
• Cytokine IL-6: High levels of IL-6 cause pulmonary and systemic tissue damage, leading to capillary leakage and SARS, the remains the main cause of death in COVID-19 patients. Mulmina® treated group showed an increase in cytokine IL-6 on day 14, which was then restored to baseline level by day 28.
• Interferon-gamma (IFN-γ): COVID‐19 patients show a higher IL‐6/IFN‐γ ratio than moderate patients, due to an enhanced cytokine storm favouring lung damage. Treatment with Mulmina® Mango resulted in a mild reduction in IFN-γ values in asymptomatic and mild symptomatic COVID-19 patients and healthcare workers.
• C-reactive protein C- reactive protein (CRP): COVID‐19 patients demonstrate a significant increase in CRP levels due to inflammatory reaction. Higher concentrations indicate more severe diseases causing lung damage and worse prognosis. Treatment with Mulmina® Mango caused a reduction in the elevated levels of inflammatory marker CRP by day 14 as compared to the control group, which continued till day 28 only in mildly symptomatic patients.
• Antibody immunoglobulin A (IgA): IgA is the most important immunoglobulin fighting infectious pathogens in the respiratory system at the point of pathogen entry. They act as an immune barrier and can neutralize SARS-CoV-2 before they reach and bind the epithelial cells. As compared with control, IgA increased in all the 3 sub-groups of the treatment group. 

Serum antioxidant markers 

• Superoxide dismutase (SOD) and catalase (CAT): SARS-CoV2 can trigger oxidative stress, which possesses even more risk to elders and people suffering from diabetes, hypertension and cardiovascular diseases. Antioxidants like SOD, CAT and GSH play an important role in reducing oxidative stress in COVID-19 patients. A statistically significant increase in SOD and CAT was observed by day 28 with Mulmina® Mango as compared with the control group in asymptomatic, symptomatic patients and healthcare workers highlighting the antioxidant potential of the product.
• Glutathione (GSH) increased by day 28 in both groups.
• Malondialdehyde (MDA): MDA is the byproduct of Oxidative stress, which acts as a marker of lipid peroxidation and can work as secondary mediators to cause further damage. The study product effectively reduced MDA levels by day 14. On day 28, there was a further decline in MDA between all the 3 subgroups in the treatment arm when compared with the control group.

Feedback - The patients gave a positive response regarding the smell and taste of the product. Also, the compliance to the product used during the trial period was 100%. 

Key observations:

Safety 

• No adverse effects were reported in the patients during the trial period.
• No abnormal vital signs (temperature, blood pressure, heart rate, pulse rate) or abnormal values in the hematology and biochemistry parameters were noted in the study group.

Conclusion-

Thus it was concluded that the components of Mulmina® Mango such as Curcuma longa, mango and Centella asiatica exhibit antioxidant and immune-boosting properties in mildly symptomatic and asymptomatic COVID-19 patients confirming the benefits of these ingredients.

Mulmina® Mango is safe for oral administration with good tolerability and its good palatability ensures patient compliance.