A randomized and comparative study to assess safety and efficacy of supplemental treatment of a herbal formulation - Aayudh Advance comprising essential oils in patients with corona virus 2019 (COVID-19)

Abstract

Objective: The purpose of this study was to examine the effect of herbal formulation - Aayudh Advance on viral load as well as recovery duration in mild symptomatic patients diagnosed with Corona Virus Disease 2019 (COVID-19). It also aimed to study the effect of Herbal formulation – Aayudh Advance in terms of clinical improvement of various sign and symptoms in mild symptomatic COVID-19 patients. Method: Once the patient suffice the requirement of inclusion, exclusion criteria of the study than as per the method of ‘Covariate Adaptive Randomization’ technique, patient was assigned in either Aayudh Advance arm (Test arm) or Control Arm. Here standard of Care treatment was given to all patients of both the arms. Treatment was given for the period of 14 days or till patient turned COVID-19 negative, which ever was earlier. Clinical signs and symptoms viz. body temperature, SpO 2, Scoring of Cough & Scoring of Shortness of breath were recorded on all 5 Clinical visits along with biochemical testing like RT-PCR (with CT value of E gene and RDRP gene), serum ferritin, CRP and NLR observed on weekly Visit. Result: Total 74 patients were enrolled in the present study. Out of which 60 patients (30 patients in each group) have completed study as per the protocol, whereas 14 patients have voluntarily withdrawn from the study due to getting early discharge from the hospital. All patients in Aayudh Advance treatment group recovered (100%) after 14 days. This observed recovery was 15.38% more as compared to Standard of Care treatment alone. Further, there was statistically significant reduction (p < 0.05) in viral load as indicated by significant increase in CT value of E-gene and RDRP gene. Further, no patients reported any Adverse Reaction as well as no drug to drug interaction was observed with supplemental treatment with Aayudh Advance. Conclusion: The Aayudh Advance was found safe as well as more effective in terms of reduction of viral load. % recovery was more in Treatment arm as compared to Control arm in mild symptomatic COVID-19 patients.

Keywords

• Aayudh advance
• COVID-19
• Standard of care (SOC)
• Adverse drug reaction
• Covariate adaptive randomization