Clinical Evaluation of a Unani formulation as adjunct therapy/add-on therapy simultaneously with the Allopathic treatment (regimen specific) in the Covid-19 patients

Ministry of AYUSH0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•RT-PCR confirmed diagnosis of COVID-19
•Provides written informed consent
•Male or non-pregnant, non-lactating female aged more than 18 years upto 60 years
•Participants with clinical syndrome associated with COVID -19 infection, presenting with either: Uncomplicated upper respiratory tract viral infection, with non-specific symptoms such as fever, cough, sore throat, nasal congestion, sneezing/running nose, loss of taste and smell, shortness of breath
•Mild pneumonia with no signs of severe pneumonia or need of supplemental oxygen therapy
•Able to take the drug orally and comply with study procedures

•Participants with severe COVID-19 symptoms with respiratory rate > 30 breaths / min and severe respiratory distress or SpO2 < 90 % on room air at the time of admission
•Participants with altered mental state
•Laboratory abnormalities at Screening, including any of the following:
•(a)AST or ALT > 2.5 times ULN (upper limit of normal)
•(b) Absolute neutrophil count < 1500/Î¼L
•(c) Serum Creatinine > ULN
•(d) Total bilirubin > ULN
•Participants with active hepatitis, tuberculosis and definite bacterial or fungal infections
•Participants with multiple organ failure requiring ICU monitoring and treatment
•Participants of respiratory failure and requiring mechanical ventilation
•Participants with persistent vomiting
•Participants with shock
•Patient who have participated in another investigational study within 3 months prior to enrolment in this study

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