A CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RECOVEREEZ FORTE TM AS AN ADJUNCT TO COVID-19 TREATMENT
Prashanth Varkey M. S M. Ch; Amita Ajit M. Tech PhD*, Aimy Hynse M.Sc, Aparajita Kumar M. Sc and Matthan Tharakan
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) provokes demanding immune and inflammatory events. Despite numerous reports on the use and testing of several potent therapeutic options against coronavirus disease 2019 (COVID-19), satisfactory treatment has not so far been determined. RECOVEREEZ FORTE TM, consisting of a standardized cardamom extract is a natural product with substantial indications of immunomodulatory and anti-inflammatory actions along with inhibitory capacity averse to viral targets. In this context, we speculated that RECOVEREEZ FORTE TM may ameliorate adverse effects in COVID-19 patients. Accordingly, in a multicenter prospective, open label, randomized trial, adult COVID-19 patients having mild to moderate symptoms were treated with RECOVEREEZ FORTE TM as an adjunct therapy. Patients were assigned to obtain standard of care along with a three times per day oral dose of 500 mg of RECOVEREEZ FORTE TM for ten days, or standard of care alone. Standard of care comprised all essential interventions, as per the discretion of the attending physician. Time to clinical improvement in terms of biochemical parameters such as IL6, CRP, D-DIMER, LDH and an RTPCR COVID-19 test negativity in the treated patients was considered to be the primary end point. We enrolled 60 patients; of which 30 were allocated to RECOVEREEZ FORTE TM and 30 to the control group. The duration of COVID-19 positivity post-intervention was significantly shorter in RECOVEREEZ FORTE TM treated group than in the control group (p<0.001). RECOVEREEZ FORTE TM group also showed significant decrease in the levels of IL6, LDH, D-dimer along with increased lymphocytes confirming its immunomodulatory and anti-inflammatory action. We conclude that RECOVEREEZ FORTE TM can reduce the impact of COVID-19 manifestations and could serve as an alternative to oral steroids. We also suggest that RECOVEREEZ FORTE TM may aid faster recovery mediated by its immunomodulatory and anti-inflammatory action in diseases other than COVID-19. The trial was registered in Clinical Trials Registry India (CTRI - CTRI/2021/04/033143) in compliance with the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use – Good Clinical Practice (ICH–GCP) guidelines.
Keywords: RECOVEREEZ FORTE TM, COVID-19, Anti-inflammatory action, Immunomodulatory action, Anti-viral Activity, Cardamom extracts.
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