A Randomized Placebo-Controlled Trial on Polyherbal Formulation as an Add-on to Standard-of-Care in Mild-to-Moderate Covid-19: Efficacy and Safety Approaches

Abstract

This chapter aims at assessing the efficacy and safety of polyherbal formution (referred as IP) in comparison to placebo, as add on to the standard of care (SOC), in patients with mild to moderate COVID- 19 patients. Hospitalized RT- PCR positive patients were randomized to either SOC þ IP or SOC þ Placebo arm. The expansion of genetic diversity among coronaviruses is primarily attributable to its wide animal host range and ability to undergo a high rate of genetic recombination and mutation. This study was a double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of polyherbal drug formulation (designated as IP) in patients with mild to moderate COVID-19. The viral load (VL) was assessed using quantitative reverse transcription-polymerase chain reaction (qRT-PCR). Immunological parameters were also assessed. The clinical improvement was assessed using a numeric rating scale (NRS) and WHO ordinal scale, and follow-up period was 30 days.

Seventy-two patients were randomized to SOC þ IP (n ¼ 39) and SOC þ Placebo (n ¼ 33) arms. There was significant reduction in  VL  in  SOC  þ IP  arm  from  day  0e4  (p  ¼ 0.002),  compared  to SOC þ Placebo arm (p ¼ 0.106). We observed that SOC + IP was associated with significant reduction in viral load at day 4. Reducing the viral load can help in early symptom recovery. It was evident as NRC was significantly reduced. Reduction in NRS also suggests improvement in respiratory health. With the ongoing COVID-19 epidemic, researchers are looking for possible antiviral medicines. This polyherbal combination medication was discovered to have effective antiviral action in COVID-19 patients with mild to moderate disease. Potential immunomodulatory actions of the medicine can also help prevent inflammatory tissue damage and lessen the severity of systemic inflammatory syndrome.

The study discovered that polyherbal formulation significantly decreases VL and promotes to immunomodulation and clinical improvement with minimal negative effects.