ABSTRACT
Background: Currently, there is no approved treatment for the management of coronavirus disease (COVID-19). Drug repurposing of existing medications could be a possible way to find out a novel therapeutic entity to combat the COVID-19. Aim: To determine the clinical efficacy and safety of an Ayurveda intervention (Guduchighana Vati) in asymptomatic and mild-to-moderate cases of COVID-19. Materials and methods: This was an open-label randomized controlled pilot study with a sample size of 30 participants (15 in each arm). The participants were asymptomatic or mild to moderate cases of COVID-19. Guduchighana Vati 500 mg twice daily for 10 days was administered in the study group and Hydroxychloroquine for 5 days in the control group. Paracetamol, Vitamin C, Multivitamin, and Zinc were also provided in the control group. The main outcome measures were to negative real-time reverse transcription-polymerase chain reaction (RT-PCR) assay for COVID-19, proportion of participants with negative RT-PCR for COVID-19 at 5th and 10th day, proportion of participants with clinical recovery, improvement in laboratory parameters, and incidence of adverse drug reaction/adverse event (ADR/AE). The results of RT-PCR and clinical recovery were compared between groups using Chi-square test. The data related to laboratory parameters were compared within group using paired sample t-test/Wilcoxon signed-rank test and between groups using independent sample t-test/Mann-Whitney test. Results: The proportion of participants with negative RT-PCR for COVID-19 in the Guduchighana Vati group (93.3%) was better as compared to the control group (66.6%) till 10th day of the study period. Though, the results are statistically not significant (P = 0.068). All the symptomatic patients in the Guduchighana Vati group clinically recovered whereas one patient remained symptomatic in the control group on the 5th day. No symptoms of COVID-19 were observed at 10th day in both the groups. No ADR/serious adverse event were observed during the study period in either of the groups. Conclusion: In this study on asymptomatic and mild to moderate cases of COVID-19, Guduchighana Vati showed numerically better proportion of participants with negative RT-PCR assay for COVID-19 and reduced time to clinical improvement which requires confirmation through studies with larger sample size. Although, the study outcomes are statistically not significant which may be due to small sample size.
ABSTRACT
INTRODUCTION: Coronavirus disease (COVID-19) is a newly identified strain of corona virus that causes illness ranging from the clinical features similar to the common cold to a fatal condition due to severe respiratory failure. According to the WHO, there have been more than 26.3 million confirmed COVID-19 cases in more than 190 countries to date. In light of the outbreak, various treatment modalities have been considered, including traditional medicine, which has been widely used in the pandemic of severe acute respiratory syndrome (SARS) and H1N1 influenza. Ayurveda contributes a measurable ratio in the world's traditional practices. As per the guideline of directorate of AYUSH, Government of Madhya Pradesh, cases of COVID-19 were intervened with Arogya Kashayam (AK-20), a decoction prepared from the herbs at 88 COVID Care Centers (CCC) across the state. AIM: To evaluate retrospectively, the effect of the intervention of AK-20 in COVID-19 positive cases as stand alone or in combination with hydroxychloroquine (HCQ) administered at CCC in Madhya Pradesh. MATERIALS AND METHODS: It is a retrospective study with 4432 COVID-19 reverse transcription-polymerase chain reaction (RTPCR) tested positive cases including 2750 males and 1682 females between 5 and 80 years of age. All the cases were intervened with AK-20 as stand alone or in combination with HCQ. Moreover, these patients were also given Zinc and Vitamin C simultaneously. The intervention of AK-20 was made through the district level government AYUSH machinery, and the related data were collected in specially designed case report form. The data were analyzed retrospectively, and outcomes included the RTPCR testing or asymptomatic discharge from the CCC as per the prevailing ICMR guidelines. RESULTS: The present study reveals that out of 4432 COVID-19 RTPCR-positive cases, 2817 (63.56%) received HCQ with AK-20 and 1615 cases (36.43%) received AK-20 as a stand alone treatment. Among the cases that received HCQ and AK-20, 2681 cases (94.17%) recovered completely in an average of 6.8 days and among those who were on standalone AK-20, 1502 cases (93.00%) recovered completely in the same average days. The Chi-square test showed that both the groups were equally effective (P < 0.01; F = 0.3764). CONCLUSION: The retrospective analysis showed that the treatment practices of AK-20 standalone or in combination with HCQ applied in COVID-19 positive cases at CCC in Madhya Pradesh were effective against SARS coronavirus 2 disease. A significant number of cases was tested negative or asymptomatically discharged from both the groups of interventions. Moreover, AK-20 alone has shown statistically equal results to that when used in combination with HCQ therapy.