An Open-Label Randomized Controlled, Proof-of-Concept (PoC) Study toEvaluate the Safety and Efficacy of selected Siddha formulations in patientsdiagnosed with COVID-19

Phase 3

Suspended

Brief Summary: As there is a sudden outbreak of Novel Coronavirus disease all over the world, there is no proven drug against the disease spread. Preliminary clinical experience with few Siddha drugs have shown their therapeutic efficacy against Novel coronavirus with clearance of SARS-CoV -2 virus from the system within 3 days of administering Siddha regimen as confirmed with qualitative RT-PCR . To scientifically validate the preliminary experience an open label randomized controlled trail will be conducted with two groups with a sample size of 200. The results of the study when generalized will help containing the pandemic.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

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.	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..	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/FiO2

Locations (1): National Institute of Siddha & other Govt . approved COVID facilities and Quarantined houses
🇮🇳
Kancheepuram, TAMIL NADU, India
National Institute of Siddha & other Govt . approved COVID facilities and Quarantined houses
🇮🇳Kancheepuram, TAMIL NADU, India
Dr G J Christian
Principal investigator
9962545930
christianvijila@gmail.com