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Herbal Steaminhaler clinical trial on COVID patients

Phase 3
Completed
Conditions
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: B342- Coronavirus infection, unspecified
Registration Number
CTRI/2020/06/026181
Lead Sponsor
HAOMA WELLNESS CENTER
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
40
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.

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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