None listed
Conditions
Interventions
Intervention1: Ayurvedic nasal drop "phoxvedic": Ayurvedic Nasal Drop refers as ââ?¬Å?pHoxvedicââ?¬? is unique combination of rationally selected 6 salts and 4
essential oils. pHoxvedic should be t
Sponsors
RAPHAEL LABS LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthcare professionals at high risk of SARS-CoV-2 exposure. 2. Normal or clinically insignificant findings during screening, medical history, medical examination, laboratory evaluations. 3. Subjects agree to refrain from taking over the counter products intended to prevent, intervene in, or treat colds/flu, starting at study entry and continuing through out study. 4. Able to give voluntary informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1. Laboratory confirmed SARS-CoV-2 positive. 2. Laboratory confirmed IgG positive for SARS-CoV-2 3. Proven history of SARS-CoV-2 infection (laboratory confirmation by PCR testing). 4. Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine. 5. Subjects, who have been partially or fully vaccinated against SARS-CoV2 with any approved vaccine. 6. History of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy. 7. Subjects with confirmed immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy. 8. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, psychiatric, or immunological disorder or any other symptoms or disorder that may interfere with study objectives as per Principal Investigator discretion. 9. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study. 10. SARS-CoV-2 vaccine planned to be administered during the study period 11. Pregnant and lactating women. 12. Participation in another clinical trial in the past 3 months. 13. History of drug / alcohol abuse. 14. Unable to complete the daily symptom tracker. 15. Unable/unwilling to follow local standard SARS-CoV-2 infection prevention measures e.g., PPE, face shield, masks etc. 16. Any nasal/sinus anatomy that will make use of the nasal spray difficult or is symptomatic to the point where it will interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects who test positive on rt-PCR for SARS-CoV-2Timepoint: Over 45 days of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute numbers of subjects with confirmed SARS-CoV-2Timepoint: Over 45 days of the study;Safety assessment via recording & reporting of: Allergies of reaction to the product (inflamed tissue etc.) Any other AE & SAE reportedTimepoint: Over 45 days of the study;Severity of disease in those confirmed SARS-CoV-2Timepoint: Over 45 days of the study;Time taken to positive test (from first dose administration) in those with confirmed SARS-CoV-2Timepoint: Over 45 days of the study;Time to symptom resolution in those confirmed SARS-CoV-2Timepoint: Over 45 days of the study;Tolerability to the IPTimepoint: Over 45 days of the study;Willingness of subjects to use formulation prior to situations of potential exposureTimepoint: Over 45 days of the study | — |
Countries
India
Contacts
Public ContactMeena Dalal
Trial Guna
Outcome results
None listed