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All Studies   Meta Analysis    Recent:   

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

Savaliya et al., AYU (An International Quarterly Journal of Research in Ayurveda), doi:10.4103/ayu.ayu_92_22, CTRI/2021/08/036010
Feb 2023  
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Recovery, combined sy.. 86% Improvement Relative Risk Recovery, day 4, dyspnea 90% Recovery, day 4, fatigue 86% Recovery, day 4, cough 79% Recovery, combine.. (b) 90% Recovery, day 7, dyspnea 86% Recovery, day 7, fatigue 89% Recovery, day 7, cough 94% Viral clearance, day 4 53% Viral clearance, day 7 95% Viral clearance, day 10 95% Andrographolide  Savaliya et al.  EARLY TREATMENT  DB RCT Is early treatment with andrographolide + combined treatments beneficial for COVID-19? Double-blind RCT 300 patients in India Improved recovery (p<0.0001) and viral clearance (p<0.0001) c19early.org Savaliya et al., AYU, February 2023 Favorsandrographolide Favorscontrol 0 0.5 1 1.5 2+
RCT with 300 mild to moderate hospitalized COVID-19 patients, showing faster recovery, faster viral clearance, and a reduction in inflammatory markers with COROPROTECT, which includes curcumin, andrographis, and several additional treatments with preclinical evidence supporting efficacy. Symptoms resolved much faster with treatment, for example at day 4 only 3% of treatment patients reported moderate dyspnea, compared to 28% for placebo. The treatment group had a significantly higher percentage of patients testing negative on days 4, 7, and 10 compared to placebo. The treatment group also showed greater reductions in CRP, LDH, and IL-6 levels. No adverse events were reported. There was no progression to serious outcomes in either group.
This study is excluded in meta analysis: many combined treatments which may significantly contribute to the effect seen.
Study covers curcumin and andrographolide.
risk of no recovery, 86.2% lower, RR 0.14, p < 0.001, treatment 150, control 150, combined symptoms.
risk of no recovery, 90.5% lower, RR 0.10, p < 0.001, treatment 4 of 150 (2.7%), control 42 of 150 (28.0%), NNT 3.9, mid-recovery, moderate symptoms, day 4, dyspnea.
risk of no recovery, 86.4% lower, RR 0.14, p < 0.001, treatment 3 of 150 (2.0%), control 22 of 150 (14.7%), NNT 7.9, mid-recovery, moderate symptoms, day 4, fatigue.
risk of no recovery, 78.9% lower, RR 0.21, p = 0.002, treatment 4 of 150 (2.7%), control 19 of 150 (12.7%), NNT 10.0, mid-recovery, moderate symptoms, day 4, cough.
risk of no recovery, 90.3% lower, RR 0.10, p = 0.006, treatment 150, control 150, combined symptoms.
risk of no recovery, 85.7% lower, RR 0.14, p = 0.25, treatment 0 of 150 (0.0%), control 3 of 150 (2.0%), NNT 50, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), moderate symptoms, day 7, dyspnea.
risk of no recovery, 88.9% lower, RR 0.11, p = 0.12, treatment 0 of 150 (0.0%), control 4 of 150 (2.7%), NNT 38, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), moderate symptoms, day 7, fatigue.
risk of no recovery, 94.1% lower, RR 0.06, p = 0.007, treatment 0 of 150 (0.0%), control 8 of 150 (5.3%), NNT 19, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), moderate symptoms, day 7, cough.
risk of no viral clearance, 53.2% lower, RR 0.47, p < 0.001, treatment 44 of 150 (29.3%), control 94 of 150 (62.7%), NNT 3.0, mid-recovery, day 4.
risk of no viral clearance, 95.0% lower, RR 0.05, p < 0.001, treatment 1 of 150 (0.7%), control 20 of 150 (13.3%), NNT 7.9, day 7.
risk of no viral clearance, 95.2% lower, RR 0.05, p = 0.002, treatment 0 of 150 (0.0%), control 10 of 150 (6.7%), NNT 15, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 10.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Savaliya et al., 21 Feb 2023, Double Blind Randomized Controlled Trial, placebo-controlled, India, peer-reviewed, mean age 35.8, 4 authors, this trial uses multiple treatments in the treatment arm (combined with combined treatments) - results of individual treatments may vary, trial CTRI/2021/08/036010. Contact: dheeraj@mprex.in.
This PaperAndrographol..All
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
References
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Balkrishna, Khandrika, Varshney, Giloy Ghanvati (Tinospora cordifolia (Willd.) Hook. F. and Thomson) reversed SARS-CoV-2 viral spike-protein induced disease phenotype in the xenotransplant model of humanized zebrafish, Front Pharmacol
Borse, Joshi, Saggam, Bhat, Walia et al., Ayurveda botanicals in COVID-19 management: An in silico multitarget approach, PLoS One
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Diomede, Beeg, Gamba, Fumagalli, Gobbi et al., Can antiviral activity of licorice help fight COVID-19 infection?, Biomolecules
Garcia, Immune response, inflammation, and the clinical spectrum of COVID-19, Front Immunol
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Sulaiman, Deepak, Ramesh, Mahesh, Anandan et al., Chemical profiling of selected Ayurveda formulations recommended for COVID-19, Beni Suef Univ J Basic Appl Sci
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