CTRI/2020/06/026181
Completed
Phase 3
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 sites40 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- HAOMA WELLNESS CENTER
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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