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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
313
Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital
Lahore, Punjab Province, Pakistan
Services Institute of Medical Sciences, Services Hospital
Lahore, Punjab Province, Pakistan
Days required to get a positive COVID-19 PCR to negative
Time frame: upto max 14 days
Severity of symptoms progression
Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe.
Time frame: upto max 14 days
Duration of Hospital Saty
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.
Time frame: upto max 14 day
30 day mortality
30 days mortality rate in each arm
Time frame: 30 days
Clinical Grade Status
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).
Time frame: 0, 4, 6, 8, 10 and 12 day
Fever
Degree of fever
Time frame: 13 days
Oxygen Saturation at room air
Time frame: upto max of 14 days
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