An open label Randomized Controlled Clinical trial to Evaluate the Safety and Efficacy of selected Siddha formulations in patients diagnosed with COVID-19
- Conditions
- Health Condition 1: B342- Coronavirus infection, unspecified
- Registration Number
- CTRI/2020/06/025768
- Lead Sponsor
- ational Institute of Siddha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 215
Male, Female and Transgenders.
ï?· Age between 18 to 85 years
ï?· COVID 19 positive asymptomatic / pre symptomatic, mild, moderate and severe COVID patients.
ï?· Willing to consent to the study.
Patients who cannot take food or drugs orally. High risk groups (Patients with Complications of Diabetes â?? DKA, DN, Severe Heart diseases and Pregnancy)
Patients with other severe medical conditions requiring intensive management.
Other viral pneumonia
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 with a history of positivity 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 Primary Outcome would be measured through Resolution of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment at specific time points. RT PCR conversion within first week with accelerated recovery as compared to control groupTimepoint: 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.Timepoint: 6 MONTHS