A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of a Nutritional Supplement (ImmuActive) for COVID-19 Patients
Majeed et al.
, A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of a Nutritional..
, Evidence-Based Complementary and Alternative Medicine, doi:10.1155/2021/8447545
RCT 100 patients in India, 50 treated with ImmuActive (curcumin, andrographolides, resveratrol, zinc, selenium, and piperine), showing improved recovery with treatment.
risk of mechanical ventilation, 66.2% lower, RR 0.34, p = 1.00, treatment 0 of 45 (0.0%), control 1 of 47 (2.1%), NNT 47, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of hospitalization, 79.7% lower, RR 0.20, p = 0.49, treatment 0 of 45 (0.0%), control 2 of 47 (4.3%), NNT 24, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
relative recovery - ordinal scale, 43.0% better, RR 0.57, p = 0.004, treatment 45, control 47, day 28.
relative time to improve one unit on ordinal scale, 30.1% lower, relative time 0.70, treatment 45, control 47.
risk of no recovery, 24.6% lower, RR 0.75, p = 0.08, treatment 26 of 45 (57.8%), control 36 of 47 (76.6%), NNT 5.3, day 28.
time to viral-, 5.8% lower, relative time 0.94, p = 0.47, treatment 45, control 47.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Majeed et al., 11 Oct 2021, Double Blind Randomized Controlled Trial, India, peer-reviewed, 4 authors, this trial uses multiple treatments in the treatment arm (combined with curcumin, andrographolides, resveratrol, selenium, and piperine) - results of individual treatments may vary.
Evidence-Based Complementary and Alternative Medicine
Volume 2021, Article ID 8447545, 9 pages
A Randomized, Double-Blind, Placebo-Controlled Study to Assess
the Efficacy and Safety of a Nutritional Supplement
(ImmuActiveTM) for COVID-19 Patients
Muhammed Majeed ,1,2 Kalyanam Nagabhushanam ,2 Kalpesh Shah ,1
and Lakshmi Mundkur 1
Sami-Sabinsa Group Limited, 19/1, 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka 560 058, India
Sabinsa Corporation, 20 Lake Drive, East Windsor, Piscataway, NJ 08520, USA
Correspondence should be addressed to Kalpesh Shah; email@example.com
Received 9 June 2021; Accepted 15 September 2021; Published 11 October 2021
Academic Editor: Changmin Hu
Copyright © 2021 Muhammed Majeed et al. This is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is
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. The primary outcome parameters were the mean change and time required to change the ordinal scale of
disease severity by one unit. The 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. The 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. The 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. There were no
adverse events observed during the study period. Conclusion. The study results suggest that ImmuActive could be a beneﬁcial and
safe adjunct treatment for eﬀectively managing COVID-19 infection symptoms.
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