Abstract
Objectives: The objective of the study is to evaluate herbal immunomodulators (Septilin and Bresol) as a possible adjuvant therapy for the treatment of asymptomatic and mildly symptomatic COVID-19. Methods: Randomized, open-label, comparative clinical study. Subjects were randomized to either arm I [Septilin and Bresol+standard of care (SOC)] or arm II (SOC). This study was registered on CTRI (CTRI/2020/06/025801). Results: Subjects in arm I showed a greater reduction in levels of interleukin-6 tumor necrosis factor-α following treatment than in arm II. Subjects in arm I showed a greater increase in levels of interferon (IFN)-β and IFN-λ than those in arm II. There was a greater reduction in D-dimer in arm I than in arm II subjects (64.28% vs. 35.59%) and all arm I subjects had D-dimer values in the normal range compared to 70% of arm II subjects. There were statistically significant reduction in lactate dehydrogenase and neutrophil-to-lymphocyte ratio in arm I (p<0.016 and p<0.013, respectively). Clinical assessments during the post-illness convalescence period showed significant improvements in fatigue assessment scores and quality of life. Conclusion: This herbal combination as an adjuvant to SOC may provide additional long-term benefits in COVID-19 infection by reducing inflammation. This treatment may offer a good addendum for the management of post-COVID-19 illness.
Highlights
After it was first reported in Wuhan, China, the infectious coronavirus disease 2019 (COVID-19; nCoV or SARS-CoV-2) spread rapidly to more than 200 countries within 3 months
The main exclusion criteria were those with a National Early Warning Score (NEWS) score ≥5; acute respiratory distress presenting with a respiratory rate >24/min, oxygen saturation (SaO2/SPO2) ≤94% in air-conditioned rooms, or an arterial oxygen partial pressure to fractional inspired oxygen (PaO2/ FiO2)ratio
Clinical assessments The subjects in the study were evaluated during the time taken for the positive CoV-reverse transcription-polymerase chain reaction (RT-PCR) result to become negative and the time taken to be discharged from hospital
Summary
After it was first reported in Wuhan, China, the infectious coronavirus disease 2019 (COVID-19; nCoV or SARS-CoV-2) spread rapidly to more than 200 countries within 3 months. The treatments available for COVID-19 are largely supportive and exploratory in nature. In the absence of strong evidence in modern medical interventions, herbal medicines may help to reduce the burden of COVID-19 which has proved to be recurrent in nature. Individual herbs and some polyherbal combinations that promoteimmune and respiratory health have undergone rigorous scientific scrutinyin clinical trials to establish their efficacy and safety. Some of these formulations could be added successfully to current treatment regimens for COVID-19
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