A RANDOMIZED CONTROL STUDY TO EVALUATE THE ROLE OF HERBAL IMMUNOMODULATORS IN BOOSTING THE IMMUNITY AND OVERALL HEALTH OF HEALTHCARE WORKERS IN COVID-19 WARDS: AN EXPLORATORY, FEEDBACK CLINICAL STUDY

Objective: The objective of the study was to evaluate the role of the herbal immunomodulators Immusante and Guduchi in boosting the immunity and overall health of healthcare workers assigned to coronavirus disease 2019 (COVID-19) wards. Methods: An open-label, randomized, prospective, and single center clinical study was conducted among 100 healthcare workers assigned to COVID-19 wards. Eligible subjects (50 in each arm) were randomly assigned to either arm I (Immusante+Guduchi tablets) or arm II (treatment as per the institutional policy). Assessments after 30 days of treatment included respiratory symptoms, Adapted Immune Status Questionnaire (ISQ), improvement in quality of life (Short form 12 [SF-12] Health Survey), and safety and tolerability. Results: All 100 subjects completed the study as per the protocol. There were no respiratory symptoms in the subjects in arm 1. However, four subjects (8%) in arm II reported cough during the study period. A better Immune status improvement was seen through the adapted ISQ in arm I as compared to arm II. In each of the 8 SF-12 Health Survey domains, a statistically significant difference was observed in arm I compared to arm II. A retrospective assessment of COVID-19 infection showed only 8% of subjects as COVID-19 positive in arm I compared with 26% of subjects in arm II. Conclusion: Considering the positive trend observed in this study in terms of ISQ, SF-12, and COVID-19 infection rates, the combination of Immusante and Guduchi in healthcare workers at a high risk of contracting COVID-19 infection had a beneficial effect in boosting immunity and overall health

THE ROLE OF HERBAL IMMUNOMODULATORS AS ADJUVANT THERAPY FOR ASYMPTOMATIC AND MILDLY SYMPTOMATIC COVID-19: AN EXPLORATORY CLINICAL STUDY

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