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60 patients (30 patients in each group) have completed study as per the protocol, whereas 14 patients have voluntarily withdrawn from the study due to getting early discharge from the hospital.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.

Role of herbal medicines in the management of patients with COVID-19: A systematic review and meta-analysis of randomized controlled trials

“…Out of 32 studies, 4 studies have not mentioned gender characteristics of the sample. 16 , 17 , 18 , 19 Overall, there were 56.96% male and 43.03% female patients. The basic characteristics of the RCTs included in the review are mentioned in Table 1 .…”

“…Six studies 17 , 18 , 26 , 30 , 33 , 34 have reported the effect of herbal intervention on improvement in number of days for hospital stay. The overall combined effect rate is represented by MD + CI (n = 388, MD -1.82; 95% CI -3.84, 0.21).…”

“…12 studies 17 , 18 , 19 , 20 , 28 , 30 , 31 , 35 , 41 , 42 , 43 , 44 have reported the effect of herbal intervention on CRP level as Mean ± SD. The net effect is a significant decrease in CRP level after treatment shown by MD + CI (n = 1423, MD -5.66; 95% CI -7.96, −3.37) [See Supplementary Fig.…”

Mechanistic insights from the review and evaluation of ayurvedic herbal medicines for the prevention and management of COVID-19 patients

“…As most of the proposed herbal treatments need to be evaluated in vivo, some recent publications were also reviewed. A randomized and comparative study to assess the safety and efficacy of supplemental treatment of a herbal formulation enriched with essential oils named “Aayudh Advance” on viral load as well as recovery duration in mild symptomatic patients diagnosed with COVID-19 was carried out by Dutt et al (2021) . They used 'Covariate Adaptive Randomization' treatment technique for 14 days and reviewed the clinical signs and symptoms and compared with traditional biochemical testing.…”

Covid-19 Impact on Divorce Case Using Sentiment Analysis

“…The Corona Virus first appeared in December 2019 in Wuhan City, Hubei Province, China (Fang-Guo et al, 2020). The Corona Virus can infect and cause respiratory diseases (Dutt , Jayesh;Ganatra , Bhavdeep;Suthar , Nilay ;Malek , Mohammedebrahim ;Shuklad , Bhakti;Shukla , Krupali;Shukla , Karna ;Pandit , Shreya;Rachchh , Manish;Gokanif, 2021). It is not yet clear how this virus is transmitted.…”