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Adhatoda vasica and Tinospora cordifolia extracts ameliorate clinical and molecular markers in mild COVID-19 patients: a randomized open-label three-armed study.

  • 2023-12-04
  • European journal of medical research 28(1)
    • Mukta Verma
    • Neha Rawat
    • Ritu Rani
    • Manju Singh
    • Aditi Choudhary
    • Sarfaraz Abbasi
    • Manish Kumar
    • Sachin Kumar
    • Ankur Tanwar
    • Bishnu Raman Misir
    • Sangeeta Khanna
    • Anurag Agrawal
    • Mohammed Faruq
    • Shalini Rai
    • Richa Tripathi
    • Anil Kumar
    • Mukta Pujani
    • Meera Bhojani
    • Anil Kumar Pandey
    • Tanuja Nesari
    • Bhavana Prasher

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 150
Population
150 COVID-19-positive patients with no to mild symptoms, between the age groups 19-65 years
Methods
randomized, open-labeled three-armed clinical trial; patients received herbal drugs orally (Group A (Adhatoda vasica; AV; 500 mg; n=50); Group B (Tinospora cordifolia; TC; 500 mg; n=43), and Group C (AV+TC; 250 mg each; n=43)) for 14 days
Blinding
Open-label
Duration
14 days
Funding
Unclear
  • Large Human Trial

Background

SARS-CoV-2 infections caused mild-to-moderate illness. However, a sizable portion of infected people experience a rapid progression of hyper-inflammatory and hypoxic respiratory illness that necessitates an effective and safer remedy to combat COVID-19.

Methods

A total of 150 COVID-19-positive patients with no to mild symptoms, between the age groups 19-65 years were enrolled in this randomized, open-labeled three-armed clinical trial. Among them, 136 patients completed the study with RT-PCR negative reports. The patients received herbal drugs orally (Group A (Adhatoda vasica; AV; 500 mg; n = 50); Group B (Tinospora cordifolia; TC; 500 mg; n = 43), and Group C (AV + TC; 250 mg each; n = 43)) for 14 days. Clinical symptoms, vital parameters, and viral clearance were taken as primary outcomes, and biochemical, hematological parameters, cytokines, and biomarkers were evaluated at three time points as secondary outcomes.

Results

We found that the mean viral clearance time was 13.92 days (95% confidence interval [CI] 12.85-14.99) in Group A, 13.44 days (95% confidence interval [CI] 12.14-14.74) in Group B, and 11.86 days (95% confidence interval [CI] 10.62-13.11) days in Group C. Over a period of 14 days, the mean temperature in Groups A, and B significantly decreased linearly. In Group A, during the trial period, eosinophils, and PT/INR increased significantly, while monocytes, SGOT, globulin, serum ferritin, and HIF-1α, a marker of hypoxia reduced significantly. On the other hand, in Group B hsCRP decreased at mid-treatment. Eosinophil levels increased in Group C during the treatment, while MCP-3 levels were significantly reduced.

Conclusions

All the patients of the three-armed interventions recovered from COVID-19 and none of them reported any adverse effects from the drugs. Group C patients (AV + TC) resulted in a quicker viral clearance as compared to the other two groups. We provide the first clinical report of AV herbal extract acting as a modifier of HIF-1α in COVID-19 patients along with a reduction in levels of ferritin, VEGF, and PT/INR as the markers of hypoxia, inflammation, and thrombosis highlighting the potential use in progression stages, whereas the TC group showed immunomodulatory effects. Trial registration Clinical Trials Database -India (ICMR-NIMS), CTRI/2020/09/028043. Registered 24th September 2020, https://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=47443&EncHid=&modid=&compid=%27,%2747443det%27.

Research Insights

Adverse Events Reported

  • Indian Tinospora→Overall tolerability

    none of them reported any adverse effects from the drugs

    Finding
    Reported
  • Adhatoda→Overall tolerability

    none of them reported any adverse effects from the drugs

    Finding
    Reported
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