Kabasura Kudineer (KSK), a poly-herbal Siddha medicine, reduced SARS-CoV-2 viral load in asymptomatic COVID-19 individuals as compared to vitamin C and zinc supplementation: findings from a prospective, exploratory, open-labeled, comparative, randomized controlled trial, Tamil Nadu, India

S Natarajan,M Pitchiahkumar,K Kanakavalli,C Anbarasi,P Prathiba,R Kathiravan,P Manickam,S Geetha,P Parthiban,P Sathiyarajeswaran,P Balaji

doi:10.1186/s13063-021-05583-0

Abstract

IntroductionDespite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation from India’s Siddha system of medicine, has been traditionally used for clinical presentations similar to that of COVID-19. We explored the efficacy of KSK in reducing viral load and preventing the disease progression in asymptomatic, COVID-19 cases.MethodsA prospective, single-center, open-labeled, randomized, controlled trial was conducted in a COVID Care Centre in Chennai, India. We recruited reverse-transcription polymerase chain reaction (RT-PCR)-confirmed COVID-19 of 18 to 55 years of age, without clinical symptoms and co-morbidities. They were randomized (1:1 ratio) to KSK (60 mL twice daily for 7 days) or standard of care (7 days supplementation of vitamin C 60,000 IU morning daily and zinc 100 mg evening daily) groups. The primary outcomes were reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR], prevention of progression of asymptomatic to symptomatic state, and changes in the immunity markers including interleukins (IL-6, IL-10, IL-2), interferon gamma (IFNγ), and tumor necrosis factor (TNF α). Siddha clinical assessment and the occurrence of adverse effects were documented as secondary outcomes. Paired t-test was used in statistical analysis.ResultsViral load in terms of the CT value (RdRp: 95% CI = 1.89 to 5.74) declined significantly on the seventh day in the KSK group and that of the control group, more pronounced in the study group. None progressed to the symptomatic state. There was no significant difference in the biochemical parameters. We did not observe any changes in the Siddha-based clinical examination and adverse events in both groups.ConclusionKSK significantly reduced SARS-CoV-2 viral load among asymptomatic COVID-19 cases and did not record any adverse effect, indicating the use of KSK in the strategy against COVID-19. Larger, multi-centric trials can strengthen the current findings.Trial registrationClinical Trial Registry of India CTRI2020/05/025215. Registered on 16 May 2020

Highlights

Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation from India’s Siddha system of medicine, has been traditionally used for clinical presentations similar to that of COVID-19
Viral load in terms of the cyclic threshold (CT) value (RdRp: 95% confidence interval (CI) = 1.89 to 5.74) declined significantly on the seventh day in the KSK group and that of the control group, more pronounced in the study group
We did an exploratory trial on COVID-19-confirmed asymptomatic individuals by comparing the standard of care of vitamin C/zinc supplementation with that of Kabasura kudineer, a polyherbal decoction from India’s traditional Siddha system of medicine

Summary

Introduction

Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation from India’s Siddha system of medicine, has been traditionally used for clinical presentations similar to that of COVID-19. Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection causing coronavirus disease 2019 (COVID-19) has affected more than 190 million people and caused 408,600 deaths globally as of 20th July 2021 [1]. Clinical symptoms of COVID-19 include mild illness (upper respiratory tract infections, fever, anorexia, malaise, muscle pain, sore throat, dyspnea, nasal congestion, headache), pneumonia, severe pneumonia, acute respiratory failure, sepsis, and septic shock [2]. People who are COVID-19-positive but do not exhibit any of the symptoms are termed asymptomatic [4]. These asymptomatic COVID-19 individuals could contribute to the rapid and extensive spread of SARS-CoV-2 [5]. The prevalence of asymptomatic individuals among SARS-CoV-2-infected people is about 40–45% [6]

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Discussion

Conclusion