Clinical trial on Immunity and antiviral for quarantine patients of COVID-19
Phase 4
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/06/025527
- Lead Sponsor
- Vopec Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Subjects age group 18 - 65 years both gender
2.Patients diagnosed with COVID-19 positive mild symptomatic patients (Confirmed by RTPCR) - Patients with uncomplicated upper respiratory infection
a.Spo2 >94% in room air
b.Respiratory rate <24 per min
c.No evidence of hypoxaemia or
breathlessness
3.Subjects willing to give a written informed consent and come for a regular follow up
4.Subject willing to abide by and comply with the study protocol
Exclusion Criteria
i.Presence of acute hypoxic respiratory failure.
ii.Intensive care unit (ICU) stay.
iii. Patients who need mechanical ventilation.
iv.Category 6 or 5 based on modified 7-category ordinal scale of clinical status
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To Evaluate The Safety And Efficacy Of Amrta Karuna syrup In mildly symptomatic COVID- 19 patients <br/ ><br>Timepoint: Day 0 to 14
- Secondary Outcome Measures
Name Time Method 1.LDH, TLC, CRP, D-DIMER and RT PCR from baseline to end of the study i.e. 14 days. <br/ ><br>2.RT PCR test will do Day 0,Day 7 and Day 10 <br/ ><br>Timepoint: Day 0,Day 7,Day 10 and Day 14