A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of a Nutritional Supplement (ImmuActiveTM) for COVID-19 Patients
Muhammed Majeed, Kalyanam Nagabhushanam, Kalpesh Shah, Lakshmi Mundkur
Evidence-Based Complementary and Alternative Medicine, doi:10.1155/2021/8447545
Background. SARS-CoV-2 has emerged as a global threat due to its infectivity and rapid transmission. We evaluated the safety and efficacy of herbal and mineral formulation (ImmuActive) as an adjunct therapy in COVID-19 patients. Methods. A randomized, double-blind, placebo-controlled study was conducted in 100 COVID-19 patients in three centers in Southern India, and 92 subjects completed the study. Subjects were followed up until they were discharged from the hospital or for a maximum of 28 days, whichever was earlier. e primary outcome parameters were the mean change and time required to change the ordinal scale of disease severity by one unit. e secondary outcomes were the time required to turn RT-PCR negative or get discharged from the hospital, change in modified Jackson's Symptom Severity score, and COVID-19 quality of life questionnaire. Results. e ordinal scale at the end of the study was significantly lower in COVID-19 patients supplemented with ImmuActive (0.57) than placebo (1.0), with a p value of 0.0043. e ordinal scale decreased by one unit within 2.35 days in ImmuActive-supplemented patients, while it took 3.36 days in placebo-supplemented patients. Days of hospitalization and time required to turn RT-PCR negative were comparatively lower in the ImmuActive arm than the placebo arm. Change in modified Jackson's Symptom Severity Score and COVID-19 QOL were significant from screening to the end of the study in both ImmuActive and placebo arms. ere were no adverse events observed during the study period. Conclusion. e study results suggest that ImmuActive could be a beneficial and safe adjunct treatment for effectively managing COVID-19 infection symptoms.
Conflicts of Interest All the authors are affiliated to Sami-Sabinsa Group Limited or Sabinsa Corporation.
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'abstract': '<jats:p>Background. SARS-CoV-2 has emerged as a global threat due to its infectivity and '
'rapid transmission. We evaluated the safety and efficacy of herbal and mineral formulation '
'(ImmuActive) as an adjunct therapy in COVID-19 patients. Methods. A randomized, double-blind, '
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'outcome parameters were the mean change and time required to change the ordinal scale of '
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