Study of a Polyherbal Formulation â??IMMURISEâ?? for improvement on the nCOVID-19 positive individuals
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/01/030663
- Lead Sponsor
- Gujarat University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Able and willing to comply with the protocol, including availability for all scheduled study visits.
2.Male and Female patients aged from 18 years to 60 years old (both inclusive).
3.Willing and able to provide written informed consent prior to performing study procedures by the subject or legal guardian willing and able to provide written informed consent prior to performing study procedures
4.Patients with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by RT Polymerase chain reaction (RT-PCR) test between 1 and 120 Hours before randomization
5.Currently hospitalized or home quarantined and requiring medical care for COVID-19
6.Peripheral capillary oxygen saturation (SpO2) > 90% on room air at screening (without CIPAP/BIPAP support)
7.Radiographic evidence of pulmonary infiltrates
8.Altered Haematological and/or Biochemical parameter like CBC, ESR, CRP, Troponin, Liver function test, Renal function test at base line.
1.Hypersensitivity to active ingredients or to any of the excipients of drug
2.Patients with Severe respiratory/cardiac/renal/hepatic dysfunction which may require ventilator (CIPAP/BIPAP) or other interventional support.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 15. The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded.Timepoint: Day 15
- Secondary Outcome Measures
Name Time Method