Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Group 1: ICU patients
Cardamom-based Sachet containing Cardamom extract 200mg, Rosemary extract 200mg Pepper extract 10mg and total cineol content 97 mg: Dose : 500 mg Dosage form :
C
Sponsors
Zum Heilen Diagnostic and Therapeutics Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-65 years of age and of either sex 2. Subjects who are willing to give consent to the study 3. COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test (RT-PCR). 4. Mild to Moderate disease (NEWS score Less than/equal to 8) 5. Can take oral medicines 6. Subject willing to abide by and comply with the study protocol
Exclusion criteria
Exclusion criteria: Age less than 18 years and more than 65 years 2. Pregnancy and lactation 3. Severe or complicated course of COVID-19 disease 4. Presence of acute hypoxic respiratory failure Any uncontrolled systemic disease, infection 6. Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease or any other disorder. 7. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the basal level inflammatory marker expression (CRP,D-Dimer,IL-6, TNF-Ã?±, IL-10) by RT-PCR in SARS-CoV -19 patients prior to treatment administration. 2. To evaluate the effectiveness of cardamom-based capsules and sachets in treating SARS CoV-2 patientsTimepoint: Day 0,Day 5 and Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs), frequency and severity at day 7 1.Number of subjects who discontinue study due to adverse events at day 7 2.Changes in vital parameters and safety laboratory parameters (liver function test, renal function test, serum electrolyte) from baseline to day 7Timepoint: Day 0 to Day 10 | — |
Countries
India
Contacts
Public ContactDr Prashanth Varkey
Zum Heilen Diagnostic and Therapeutics Pvt. Ltd
Outcome results
None listed