Safety and efficacy of COROPROTECT kit as an add-on therapy in the management of mild-to-moderate COVID-19: A randomized, placebo-controlled trial
Chetan Savaliya, Shridhar Pandya, Kamalesh Thumar, Dr Dheeraj Nagore
AYU (An International Quarterly Journal of Research in Ayurveda), doi:10.4103/ayu.ayu_92_22
Background: The constructive role of Ayurveda in managing COVID-19 has been widely discussed, with identified herbs showing immunomodulatory and anti-viral potential. However, clinical trials examining their safety and efficacy are limited. Aim: The aim of this study is to determine the efficacy of COROPROTECT kit, a proprietary Ayurvedic formulation, in COVID-19. Materials and method: Randomized, placebo-controlled trial with 312 mild to moderate hospitalized COVID-19 patients. Groups received COROPROTECT or placebo for 10 days alongside standard care. Results: The outcome measures included the number of days taken to reverse the reverse transcriptase-polymerase chain reaction (RT-PCR) status, reduction in symptoms and inflammatory markers. Fisher exact test was used to analyze the changes between categorical variables, whereas the comparative effect of therapy in both groups on inflammatory markers and safety biochemical parameters was analyzed using Student's t test. A total of 300 patients completed the study without any adverse events. The COROPROTECT kit group exhibited a statistically significant higher percentage of patients testing negative on days 4, 7, and 10 compared to the placebo group. A within group analysis showed that trial group to significantly reduced the levels of C-reactive protein (P = 0.03), lactate dehydrogenase (P < 0.001), and interleukin-6 (P = 0.01). Subjects of the trial group experienced complete relief from cough (69.33%), breathlessness (65.33%), and fatigue (62.67%) within 4 days. In contrast, the placebo group had 20%-40% of participants with mild symptoms persisting until day 10.
Conclusion: This study suggests potential future implications, indicating a faster RT-PCR negativity, reduced COVID-19 severity, and inflammatory markers, along with early symptomatic recovery. The COROPROTECT kit proved safe, facilitating an accelerated clinical recovery compared to conventional care.
Conflicts of interest There are no conflicts of interest.
Supplementary File About the trial drug Gplife "COROPROTECT tablet and COROPROTECT dry syrup" are successfully tested and demonstrated good efficacy in Anti-SARS-CoV-2 activity with 85% and 72% SARS-CoV-2 inhibition in 24 hrs was carried out at Government of India approved, Department of Biotechnology, Institute of Life science-Bhuvneshwar. Both these products have received Ayurvedic medicine license by FDCA, Gujarat. The COROPROTECT tablet and COROPROTECT dry syrup formulations were tested for its antioxidant activity by In vitro analysis, and standardization of the both was carried out by using HPLC method.
Detailed description of the ingredients, quantity and specifications of preparation of COROPROTECT kit
Each coated tablet contains
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'abstract': '<jats:title>Abstract</jats:title>\n'
' <jats:sec>\n'
' <jats:title>Background:</jats:title>\n'
' <jats:p>The constructive role of Ayurveda in managing COVID-19 has been widely '
'discussed, with identified herbs showing immunomodulatory and anti-viral potential. However, '
'clinical trials examining their safety and efficacy are limited.</jats:p>\n'
' </jats:sec>\n'
' <jats:sec>\n'
' <jats:title>Aim:</jats:title>\n'
' <jats:p>The aim of this study is to determine the efficacy of COROPROTECT kit, a '
'proprietary Ayurvedic formulation, in COVID-19.</jats:p>\n'
' </jats:sec>\n'
' <jats:sec>\n'
' <jats:title>Materials and method:</jats:title>\n'
' <jats:p>Randomized, placebo-controlled trial with 312 mild to moderate '
'hospitalized COVID-19 patients. Groups received COROPROTECT or placebo for 10 days alongside '
'standard care.</jats:p>\n'
' </jats:sec>\n'
' <jats:sec>\n'
' <jats:title>Results:</jats:title>\n'
' <jats:p>The outcome measures included the number of days taken to reverse the '
'reverse transcriptase-polymerase chain reaction (RT-PCR) status, reduction in symptoms and '
'inflammatory markers. Fisher exact test was used to analyze the changes between categorical '
'variables, whereas the comparative effect of therapy in both groups on inflammatory markers '
'and safety biochemical parameters was analyzed using Student’s <jats:italic '
'toggle="yes">t</jats:italic> test. A total of 300 patients completed the study without any '
'adverse events. The COROPROTECT kit group exhibited a statistically significant higher '
'percentage of patients testing negative on days 4, 7, and 10 compared to the placebo group. A '
'within group analysis showed that trial group to significantly reduced the levels of '
'C-reactive protein (<jats:italic toggle="yes">P</jats:italic> = 0.03), lactate dehydrogenase '
'(<jats:italic toggle="yes">P</jats:italic> < 0.001), and interleukin-6 (<jats:italic '
'toggle="yes">P</jats:italic> = 0.01). Subjects of the trial group experienced complete relief '
'from cough (69.33%), breathlessness (65.33%), and fatigue (62.67%) within 4 days. In '
'contrast, the placebo group had 20%–40% of participants with mild symptoms persisting until '
'day 10.</jats:p>\n'
' </jats:sec>\n'
' <jats:sec>\n'
' <jats:title>Conclusion:</jats:title>\n'
' <jats:p>This study suggests potential future implications, indicating a faster '
'RT-PCR negativity, reduced COVID-19 severity, and inflammatory markers, along with early '
'symptomatic recovery. The COROPROTECT kit proved safe, facilitating an accelerated clinical '
'recovery compared to conventional care.</jats:p>\n'
' </jats:sec>',
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