From the clinical researcher’s desk

Introduction 

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

Objective 

The study evaluated the immune-boosting activity of Mulmina® Amla Orange 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.

The study included 40 patients receiving Mulmina® Amla Orange twice a day and 40 patients receiving 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): COVID-19 patients have significantly increased SAA levels are more likely to have worsening conditions. SAA increase was observed in all the enrolled patients and was statistically significant between both the groups.
• Cytokine interleukin 4: No significant increase was noted in the levels of cytokine interleukin 4 (IL-4) from day 0 through day 28 in Mulmina® treated group.
• 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. Although an increase in cytokine IL-6 was noted on day 14, the study product was efficient in restoring them 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 favoring lung damage. Mulmina® Amla orange showed a drastic reduction in IFN-γ in healthcare workers and mild asymptomatic patients by day 28.
• 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® Amla Orange 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. 

Serum antioxidant markers 

• Antibody immunoglobulin A (IgA): IgA is the most important immunoglobulin fighting infectious pathogens in the respiratory system at the point of pathogen entry. Acting as an immune barrier, they 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. 
• 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 are known to reduce oxidative stress in COVID-19 patients. A statistically significant increase in SOD and CAT was observed by day 28 with Mulmina® Amla Orange 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 group.
• 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 was effective in reducing 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® Amla Orange like orange and amla extracts elevates the antioxidant levels in the COVID-19. Mulmina® Amla Orange is safe for oral administration with good tolerability and its good palatability ensures patient compliance.