COVID-19 Research

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Objective: Preparation of cGMP batch of aqueous extracts for all the products viz.; Glycyrrhizaglabra; Tinosporacordifolia + Piper longum; Withaniasomnifera; CMC-quality control for all the products as per AYUSH guidelines; Preparation of clinical trial batches; Formulation development of all the products; Stability studies of all the formulations; and Two sets clinical trials; Phase II clinical trial for add-on intervention to symptomatic COVID-19 patients; Phase II clinical trial for Withaniasomnifera as prophylactic intervention in high risk individuals. Study duration 12 weeks:

Summary: The rapid increase in the number of COVID-19 patients is posing tremendous challenge for the healthcare systems across the world. Effective strategies for prophylaxis and holistic management are of paramount importance. It is necessary to curtail the progress of the disease to reduce increased burden on hospitals. As of now there are no proved drugs or therapy in modern medicine. Therefore, strategies to boost immunity and improved resistance to fight against SARS-CoV-2 infection remain a current priority. Ayurveda Rasayana drugs are known to possess immunomodulatory, antioxidant and apoptogenic activity. Available scientific literature offers reasonably good empirical evidence to support their use in prophylaxis and as an add-on treatment to current standard of care. Based on available scientific literature, three potential botanical candidates have been selected to study their effects in prophylaxis and or add-on therapy for holistic management of COVID-19. This proposal provides overall background, rationale, approach and methodology to be adopted for a multi–council, multi–institutional, multi-centric national network project to systematically investigate selected three drugs in well-designed clinical studies at reputed hospitals from different regions of India.

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