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Efficacy and safety of Guduchighana Vati in asymptomatic and mild-to-moderate cases of coronavirus disease-19: A randomized controlled pilot study
Umesh Shukla1, Nitin Ujjaliya2, Pankaj Gupta3, Vivek Khare4, Babita Yadav5, Amit Kumar Rai5, Hetalben Amin5, Rakesh Rana6, Arunabh Tripathi6, Shruti Khanduri5, Bhagwan Sahay Sharma5, Bhogavalli Chandrasekhararao5, Narayanam Srikanth7, Kartar Singh Dhiman8
1 Principal & CEO, Pt. Khushilal Sharma Government (Autonomous) Ayurveda College & Institute, Bhopal, Madhya Pradesh, India
2 Department of Dravyaguna, Pt. Khushilal Sharma Government (Autonomous) Ayurveda College & Institute, Bhopal, Madhya Pradesh, India
3 Department of Rachana Sharira, Pt. Khushilal Sharma Government (Autonomous) Ayurveda College & Institute, Bhopal, Madhya Pradesh, India
4 Department of Pathology, Pt. Khushilal Sharma Government (Autonomous) Ayurveda College & Institute, Bhopal, Madhya Pradesh, India
5 Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Government of India
6 Department of Biostatistics, Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Government of India
7 Director General (Additional Charge), Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Government of India
8 Former Director General, Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Government of India
Correspondence Address:
Amit Kumar Rai
61-65, Institutional Area, Opposite D-Block, Janak Puri, New Delhi - 110 058
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/ayu.ayu_11_21
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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.
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