Honey & Nigella Sativa Trial Against COVID-19
- Conditions
- Coronavirus InfectionSars-CoV2
- Interventions
- Registration Number
- NCT04347382
- Lead Sponsor
- Sohaib Ashraf
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 313
- Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result with SSC-2 score> 5
- Patients admitted in Corona centers
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nigella Sativa & Honey Group Nigella Sativa / Black Cumin Drug: Nigella Sativa seed Powder 80 mg/Kg/day grinded in capsule upto a max of 14 days) Drug: Natural Honey 1gm/kg/day orally upto a max of 14 days) along with standard medical care Standard Medical Care Placebos Standard supportive medical care prescribed by treating physician, Lahore which includes standard symptomatic care along with use of antibacterial or antiviral (if advised by pulmonologist or infectious disease specialist) Nigella Sativa & Honey Group Honey Drug: Nigella Sativa seed Powder 80 mg/Kg/day grinded in capsule upto a max of 14 days) Drug: Natural Honey 1gm/kg/day orally upto a max of 14 days) along with standard medical care
- Primary Outcome Measures
Name Time Method 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.
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.
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).
Fever 13 days Degree of fever
- Secondary Outcome Measures
Name Time Method Oxygen Saturation at room air upto max of 14 days
Trial Locations
- Locations (2)
Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital
🇵🇰Lahore, Punjab, Pakistan
Services Institute of Medical Sciences, Services Hospital
🇵🇰Lahore, Punjab, Pakistan