CTRI/2020/06/026181已完成3 期
A Prospective, Open Label, multi Center clinical Study to evaluate the Safety, Efficacy And Tolerability Of AZADVIR (Herbal Steaminhaler) In Asymptomatic, Mildly Symptomatic COVID -19 Patients And Health Care Workers Posted To Covid Wards
HAOMA WELLNESS CENTER0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or non-pregnant female adult with or without comorbidities between the agre group of 18-85 years of age at time of enrollment
- •2.Has laboratory-confirmed positive COVID-19 infection as determined by RT-PCR or other commercial or public health assay in any specimen, an RT-PCR (Nasopharynx, Throat, and Blood) test shall be repeated to assess eligibility
- •3.Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures
- •4.Health care workers who visited to COVID patients
排除标准
- •1.Testing positive for HIV, HbsAg, HCV infection, VDRL.
- •2.Females who are currently pregnant or breastfeeding.
- •3.Allergy or other contraindication to one of the investigational products.
- •4.Has received Eflornithine within the last 10 days.
- •5.Has received anti-viral, anti-malarial or anti-bacterial within the last 14 days.
- •6.Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN).
- •7.QTc interval >= 500ms.
- •8.Recent Myocardial Infarction (within last 6 months).
- •9.Known case of (K/C/O) Congestive heart failure.
- •10.K/C/O Chronic Kidney Disease.
- •11.K/C/O active Tuberculosis.
- •12.History of drug or alcohol dependence in the past 6 months.
- •13.In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- •14.Anticipated transfer to another hospital which is not a study site within 72 hours.
- •15.K/C/O of epilepsy or CNS disorders.
研究者
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