Study of the effect of Siddha Treatment in addition to standard therapy in COVID-19 patients

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: Intervention1: 1. Kabasura kudineer 2. Bramanandha bairavam: 1. Kabasura kudineer 60 ml twice daily (90 minutes before food ‐ Morning 7.00 and evening 6.00) for 14 days 2. Bramanandha bairavam 100 mg thrice daily (30 minutes after food) with honey or ginger juice for 14 days Control Intervention1: Standard Covid Treatment Protocol: As Standard of care recommended by ICMR A. Mild symptoms: 1. Tablet Oseltamivir 2. Antibiotics if needed (azithromycin + amoxicillin /clavulanic acid) 3. Paracetamol B. Moderate symptoms 1. Oxygen supplementation 2. Antipyretics, antitussives, antibiotics as indicated 3. Metered Dose Inhaler preferred over nebulization 4. Hydroxychloroquine 5. Lopinavir/ Ritonavir (within 10 days of symptom onset) may be considered on case to cases CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: Proportion of patients confirmed as negative for SARS‐CoV‐2 in 2 consecutive throat/nasal swabs (taken 24 hours apart) at Day 15/Day16.Timepoint: To compare the efficacy of Siddha drug regimen plus Standard of Care (SoC) with SoC alone in the treatment of Covid‐19 positive patients. SECONDARY OUTCOME: To compare the safety of Siddha drug regimen plus Standard of Care (SoC) with SoC alone in the treatment of Covid‐19 positive patients.Timepoint: 1. Time taken from patients to become asymptomatic from symptomatic ; 2. Mean viral load change from baseline at Day 15 ; 3. Mortality rate ; 4. Length of hospitalization ; Note: Hospitalization means patients who require parenteral [eg. Intravenous (IV)] medications or IV fluids, oxygen or ventilatory support. Mere isolation or quarantine inside the hospital premises will not be considered as hospitalization ; 5. Time to achieve National Early Warning Score (NEWS) equal to zero (Appendix III). INCLUSION CRITERIA: 1. Males and females aged 18 to 75 years, both inclusive 2. Have laboratory confirmed COVID‐19 disease 3. Asymptomatic patients (who are positive for SARS CoV‐2 and with no symptoms) or meets clinical features of the following grades of severity (Appendix II): a. Group 1: Suspect and confirmed cases clinically assigned as mild and very mild Clinical criteria: Cases presenting with fever and/or upper respiratory tract illness (Influenza Like Illness, ILI). b. Group 2: Suspect and confirmed cases clinically assigned as moderate Clinical criteria: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30 breaths/minute, SpO2 90%‐94%). 4. Agrees to practice contraception during the entire study treatment period and for 3 months after the last treatment of IMP is administered: a. Using double barrier contraception, b. or, is truly sexually abstinent, when this is in li
Epistemonikos ID: d4e564f9f17c4eb2366703abad078f667c586e11
First added on: Jul 07, 2020