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Clinical Trials/CTRI/2020/06/026181
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.

Registry
who.int
Start Date
TBD
End Date
January 21, 2021
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
HAOMA WELLNESS CENTER

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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