Clinical trial on Covid patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/10/037368
- Lead Sponsor
- utan Labs OPC Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1.Subjects aged 18-65 years of age and of either sex
2.Subjects who are willing to give consent to the study
3.COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test (Nasal swab RT-PCR).
4.Mild to moderate clinical disease
5.Can take oral medicines
6.Subject willing to abide by and comply with the study protocol
1.Age less than 18 years and more than 65 years
2.Pregnancy and lactation
3.Severe or complicated course of COVID-19 disease
4.Presence of Pneumonia/ acute hypoxic respiratory failure/ need for Intensive care unit (ICU) stay/ Patients who need mechanical ventilation.
5.Subjects taking steroid treatment and or any kind of immunosuppressive therapy
6.Any uncontrolled systemic disease/ infection
7.Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or renal disease or any other disorder.
8.Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To Evaluate the Safety and Efficacy of COVIRAKSHA to Resolution of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment <br/ ><br>2.Improvement in the clinical features in mild to moderate Covid patients. <br/ ><br>3.Mean time (days) for clinical recovery <br/ ><br>Timepoint: Day 0 to Day 14
- Secondary Outcome Measures
Name Time Method 1.Adverse events (AEs), frequency and severity <br/ ><br>2.Number of subjects who discontinue study due to adverse events <br/ ><br>Timepoint: Day 0 to Day 14