Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Tab. Bresol and Tab. Septilin: Each tablet is recommended at a dose of 1 tablet twice daily orally (BD) for the specified duration of treatment (from day 1 upto14 days from the discharg
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects who are COVID-19 confirmed cases, with mild severity presenting with signs and symptoms qualifying for Low Clinical Risk (News Scoring 0-4) 2. Subjects with SARS-CoV-2 RT-PCR confirmed COVID-19 positive within 7 days from symptom onset or Patients within 48 hours after laboratory diagnosis (SARS-CoV-2 RT-PCR). 3.Female of childbearing potential willing to follow reliable and strict contraceptive measures. 4.Subject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment and compliance to quarantine procedure (as per prevailing guidelines). 5. Able to give written inform consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Confirmed COVID-19 positive cases with NEWS scoring system >=5. 2.Individual with acute respiratory distress presenting with RR > 24/mt, SaO2/SPO2 3.Pregnant or breastfeeding females. 4.Recent history of significant lung disease like Asthma or Chronic Obstructive Lung Disease (COPD). 5.Unable to take oral medication or suffering from ailments related to absorption. 6.Suffering from Immunocompromising conditions or taking any immunosuppressing therapy. 7.Subjects suffering from severe and uncontrolled metabolic, endocrinal, cardiac/ renal/liver disease. 8.The subject with known hypersensitivity to any of the test materials or related compounds. 9.The subject who are unable or unwilling to comply fully with the study protocol. 10.Physician makes a decision that trial involvement is not in patients best interest, or any condition that does not allow the protocol to be followed safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Clinical Recovery No. & Percentage (%) of subjects converting into severe cases. Time to convert 2019 nCoV RT PCR in negative in upper respiratory tract specimen Lenth of Hospital stay Proportion of clinical failure -ICU admission, mechanical ventilation or death Number & Percentage (%) of subjects converting into positive test for COVID-19 Protection as defined by various laboratory parameters related to inflammation and immunity Overall well-beingTimepoint: Visit-1 Baseline Visit-2 Date of discharge Visit-3(Telephonic) 7 days from the date of discharge±1day Visit-4 14 days from the date of discharge ±3day (EOS) | — |
Secondary
| Measure | Time frame |
|---|---|
| No. & Percentage (%) of subjects having recurrence of COVID-19 within two weeks after discharge cases. Incidence of any opportunistic infection Incidence of adverse effects Study Drug ComplianceTimepoint: Visit-1 Baseline Visit-2 Date of discharge Visit-3(Telephonic) 7 days from the date of discharge±1day Visit-4 14 days from the date of discharge ±3day (EOS) | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
The Himalaya Drug Company
Outcome results
None listed