Efficacy and safety of Link Natural Sudarshana tablet (an Ayurvedic medicine) against COVID-19 infection – A single center, randomized double-blind, placebo-controlled clinical trial

Phase 2

• Conditions: COVID-19

• Registration Number: SLCTR/2021/002
• Lead Sponsor: ink Natural Products (Pvt) Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Complete: follow up complete
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

• Patients who are over 18 years of age

• Both male and female

• Confirmed diagnosis of COVID-19 by a PCR test nasopharyngeal/throat/sputum swab within 48 hours
prior to randomization [at hospital reception before admission]

• Onset of one or more of COVID-19 related symptoms and/or signs of mild to moderate disease within 96 hours prior to randomization. [Symptoms of mild disease are: i. Fever ii. Cough iii. Sore throat iv. Malaise v. Headache vi. Muscle pain vii. Gastrointestinal symptoms. Signs of moderate disease (in addition to symptoms of mild disease) i. Shortness of breath with exertion ii.Respiratory rate >= 20 but <30/min iii.Saturation of oxygen >93% of room air iv.Heart rate >= 90/min but <125/min]

Exclusion Criteria

* Patients who have a known allergy to the Ayurveda drug Sudarshana Cúrna or Link Natural Sudarshana Tablet (LNST) or any of its components.

* Pregnant women (confirmed or suspected with a history of a missing menstrual period for more than a week)

* Breast-feeding mothers

* Patients with cerebrovascular disease, or stroke, or ischaemic heart disease, or diabetes, or hypertension, or history of liver disease, or renal disease (all the patients will be screened for diabetes (DM), or high blood pressure (BP). Even without a history DM or high BP, if the random blood sugar done on admission is >200 mg/dL, or if the systolic blood pressure is >140 or diastolic blood pressure is > 90 mmHg, they will be excluded from the study)

* Patients with severe disease as indicated by SpO2 <=93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate >=30 per minute, heart rate >=125 per minute (38c)

*Patients with critical disease ie. those who require mechanical ventilation or anticipated impending need for mechanical ventilation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
87% reduction of viral burden by measuring semi-quantitative viral RNA of SARS-COV-2 as measured by cycle threshold from nasopharyngeal swabs. (viral burden is calculated using the Ct values as done in BALZE-1 study protocol. Ref. Chen, P.et al. (2020). SARS-CoV-2 Neutralizing Antibody LY-CoV555 in<br>Outpatients with Covid-19. New England Journal of Medicine.doi:10.1056 /nejmoa2029849)<br> [Day 11 from the date of intervention]<br>Clinical progression using the WHO ordinal outcome scale - WHO Working Group on the Clinical Characterisations and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis 2020. Published Online June 12, 2020. https://doi.org /10.1016/S1473-3099(20)30483-7) [Day 6, 10 and 14 from the date of intervention]<br>