Coronavirus Infection, Sars-CoV2
Conditions
Keywords
SARS-CoV-2, COVID-19, Coronavirus, Honey, Nigella Sativa, Black Cummin, Herbal Medicine
Brief summary
To evaluate the effectiveness of Nigella Sativa and honey stirred in 250 ml of distilled water 12 hourly till patient becomes asymptomatic or a maximum of 14 days with standard hospital care versus standard hospital care alone with placebo capsule and 250 ml water, in clearing the COVID-19 nucleic acid from throat and nasal swab, lowering disease detrimental effects on HRCT chest/X-ray and severity of symptoms along with duration of hospital stay till day 14th day of follow up and 30 days mortality (primary outcomes).
Detailed description
This cohort, adaptive, randomized, double armed group, controlled, Investigator Initiated interventional study is designed to demonstrate the superiority of a combination of black cumin with honey over standard care in SARS-CoV-2 (COVID-19) infected patients who consent to randomization following a new diagnosis in Pakistan with an SSC-2 score of \> 5 with positive RT-PCR of COVID-19.
Interventions
DRUGHoney
1gm/Kg/Day
DRUGNigella Sativa / Black Cumin
80mg/Kg/day
DRUGPlacebos
Empty capsule with 250ml of distilled water
Sponsors
Sohaib Ashraf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result with SSC-2 score\> 5 * Patients admitted in Corona centers
Exclusion criteria
* Participants not giving consent. * Pregnant and lactating females. * History of allergy to any drug being administered in this study * Severely terminally ill patients * Patients on Nil Per Oral
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hospital Saty | upto max 14 day | Duration of hospital stay would be categorized as the number of days the patient stayed in the ward during treatment. The date of admission and date of discharge would give us total duration of stay. |
| Days required to get a positive COVID-19 PCR to negative | upto max 14 days | — |
| Severity of symptoms progression | upto max 14 days | Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe. |
| Fever | 13 days | Degree of fever |
| 30 day mortality | 30 days | 30 days mortality rate in each arm |
| Clinical Grade Status | 0, 4, 6, 8, 10 and 12 day | grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death). |
Secondary
| Measure | Time frame |
|---|---|
| Oxygen Saturation at room air | upto max of 14 days |
Countries
Pakistan
Outcome results
None listed