Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
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
Sponsors
Eminentlabs Business Solutions Pvt Ltd
Eligibility
Inclusion criteria
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 line with the preferred and usual lifestyle of the participant Note: Periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner with childbearing potential] and withdrawal are not acceptable methods of contraception. 5. Patients or their legal representatives have personally signed and dated the informed consent form (ICF) before completing any study-related procedure, which means before any assessment or evaluation that would not have formed a part of his/her normal medical care 6. Patients willing to adhere and comply with the protocol related procedures 7. Patients willing to take Siddha drug regimen for COVID-19 8. Agrees not to participate in other clinical studies within 30 days after the last administration of the study drug
Exclusion criteria
Exclusion criteria: 1. Patients with other viral pneumonia 2. Patients with severe or critical COVID-19 disease 3. Patients who have taken antibiotics/antivirals in the past 1 week 4. Patients with history of asthma, chronic obstructive pulmonary disease or any other chronic lung disease 5. Patients with any active malignancy 6. Patients who have received organ transplantation in the past 6 months or planning surgery 7. Patients who cannot take food or drugs orally 8. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption 9. Patients who have severe underlying diseases that affects survival, including blood diseases, dyscrasia, active bleeding, severe malnutrition, etc 10. Patients with uncontrolled blood pressure (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg) or uncontrolled diabetes (HbA1C >7%) 11. Women patients who are pregnant or lactating, or patients (including male patients) having a pregnancy plan (including plans for sperm donation or egg donation) 12. Patients with allergic constitution, or patients allergic to investigational products 13. Patients positive for human immunodeficiency virus, Hepatitis B and Hepatitis C at screening 14. Patients whose alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal 15. Patients requiring Extracorporeal Life Support Program (ECLS), i.e. Extracorporeal Membrane Oxygenation (ECMO), Extracorporeal carbon dioxide removal (ECCO2R) or Registered Respiratory Therapist (RRT) 16. Critical patients with life expectancy 17. Patients who are not suitable to participate in the study based on the investigatorâ??s judgement 18. Patients who have participated in any clinical trial 30 days prior to screening 19. Clinically significant laboratory findings at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
India
Contacts
Public ContactDr JEYA VENKATESH
Kokila Siddha Hospital and Research Centre
Outcome results
None listed