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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.

  • 2021-09-15
  • Trials 22(1)
    • S Natarajan
    • C Anbarasi
    • P Sathiyarajeswaran
    • P Manickam
    • S Geetha
    • R Kathiravan
    • P Prathiba
    • M Pitchiahkumar
    • P Parthiban
    • K Kanakavalli
    • P Balaji

Study Design

Type
Randomized Controlled Trial (RCT)
Population
asymptomatic COVID-19 patients aged 18-55 without comorbidities
Methods
Prospective, single-center, open-labeled, randomized controlled trial; KSK 60 mL twice daily for 7 days vs standard of care (vitamin C 60,000 IU and zinc 100 mg daily for 7 days)
Blinding
Open-label
Duration
7 days

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. We explored the efficacy of KSK in reducing viral load and preventing the disease progression in asymptomatic, COVID-19 cases.

Methods

A 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.

Results

Viral 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.

Conclusion

KSK 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 registration

Clinical Trial Registry of India CTRI2020/05/025215 . Registered on 16 May 2020.

Research Insights

Adverse Events Reported

  • Zinc→Overall tolerability

    We did not observe any changes in the Siddha-based clinical examination and adverse events in both groups.

    Finding
    Reported
  • Vitamin C→Overall tolerability

    We did not observe any changes in the Siddha-based clinical examination and adverse events in both groups.

    Finding
    Reported
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