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

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: Intervention1: Kabasura kudineer; Amukkara choornam; Nelikai legiyum: KS kudineer will be administered twice a day in asymptomatic COVID patients; and will be administered thrice a day in symptomatic individuals just before or after food. Apart from this medication, Convalescent medication is prescribed namely Amukkara choornam 2gms bid and Nellikkai ilagam 5gms bid for 15 days. Control Intervention1: Not applicable: Not applicable CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: 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: 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/FiO2Timepoint: 6 MONTHS 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.
Epistemonikos ID: 842e2942d3afcd15db63d9dea4296fe665661e62
First added on: Jul 07, 2020