Honey & Nigella Sativa Trial Against COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Role of Honey and Nigella Sativa in the Management of COVID-19; A Randomized Controlled, Open-label, Add-on Trial in Pakistan

Conditions
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Sars-CoV2, Coronavirus Infection

Intervention / Treatment
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* Drug: Honey
* Drug: Nigella Sativa / Black Cumin
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nigella Sativa & Honey Group<br>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 | Drug: Honey<br>* 1gm/Kg/Day<br>Drug: Nigella Sativa / Black Cumin<br>* 80mg/Kg/day<br>|
| Placebo Comparator: Standard Medical Care<br>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) | Drug: Placebos<br>* Empty capsule with 250ml of distilled water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days required to get a positive COVID-19 PCR to negative |  | 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. | 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. | upto max 14 day | 
| 30 day mortality | 30 days mortality rate in each arm | 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). | 0, 4, 6, 8, 10 and 12 day | 
| Fever | Degree of fever | 13 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Saturation at room air |  | upto max of 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19, Coronavirus, Honey, Nigella Sativa, Black Cummin, Herbal Medicine