Randomized Double-Blind Phase II Clinical Trial to Assess the Efficacy and Safety of an Ayurvedic Formulation, in COVID-19 Infected Patients

ink Natural Products (Pvt) Ltd0 个研究点开始时间: 待定最近更新: 2024年8月20日

研究概览

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•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]

•* 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

发起方

ink Natural Products (Pvt) Ltd