An Open-Label Randomized Controlled, Proof-of-Concept (PoC) Study toEvaluate the Safety and Efficacy of selected Siddha formulations in patientsdiagnosed with COVID-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/06/025762
- Lead Sponsor
- ational Institute of Siddha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
ï?· Male, Female and Transgenders.
ï?· Age between 18 to 85 years
ï?· COVID 19 positive asymptomatic / pre symptomatic, mild and moderately symptomatic patients.
ï?· Willing to consent to the study.
Patients who have received organ transplantation in the past 6 months or planning surgery.Patients with severe or critical covid-19 infections.Patients with any active malignancy. Patients who have severe underlying diseases that affects survival, including blood diseases,dyscrasia, active bleeding, severe malnutrition, etc.
Patients with allergic constitution, or patients allergic to investigational products
Patients positive for HIV, Hepatitis B and Hepatitis C at screening.Critical patients with life expectancy <48 hours. Septicemia / Multi organ failure Syndrome (MODS).Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal.Patients participating in other COVID 19 trials.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome would be measured through Reduction of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment at specific time points.Timepoint: 6 months
- Secondary Outcome Measures
Name Time Method Possible reduction of viral load data in subsets of both groups both at baseline and at 7 days, and14 days or at recovery or 30 days whichever is earlier.. <br/ ><br>ï?· Sub group analysis for male, female and Age groups will also be studied in each group. Number of days on treatment before recovery and case fatality rate if any will be documented.Reduction in Signs and symptoms like Fever, cough, breathlessness, and improvement in O2 saturation (SpO2) and PaO2/FiO2Timepoint: 6 MONTHS