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| ID | Type | Description | Link |
|---|---|---|---|
| IRB/2020/658/SIMS | Other Identifier | Services Institute of Medical Sciences, Services Hospital, Lahore, Pakistan |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nigella Sativa & Honey Group | Experimental | 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 | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Honey | Drug | 1gm/Kg/Day |
| |
| Nigella Sativa / Black Cumin |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation at room air | upto max of 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shoaib Ashraf, PhD | Massachusetts General Hospital, Harvard Medical School, USA | Study Director |
| Muhammad Ashraf, DVM, PhD | University Of Veterinary & Animal Sciences, Lahore | Study Chair |
| Sohaib Ashraf, MBBS | Federal Post-Graduate Medical Institute, Lahore | Principal Investigator |
| Muhammad Ahmad Imran, MBBS | Shaikh Zayed Hospital, Lahore | Principal Investigator |
| Ayesha Hamayun, MBBS, PhD | Shaikh Khalifa Bin Zayed Al-Nahyan Medical & Dental College, Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital | Lahore | Punjab Province | 54600 | Pakistan | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24413991 | Background | Ulasli M, Gurses SA, Bayraktar R, Yumrutas O, Oztuzcu S, Igci M, Igci YZ, Cakmak EA, Arslan A. The effects of Nigella sativa (Ns), Anthemis hyalina (Ah) and Citrus sinensis (Cs) extracts on the replication of coronavirus and the expression of TRP genes family. Mol Biol Rep. 2014 Mar;41(3):1703-11. doi: 10.1007/s11033-014-3019-7. Epub 2014 Jan 12. | |
| 28480371 |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Not provided
| ID | Term |
|---|---|
| D006722 | Honey |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Drug |
80mg/Kg/day |
|
| Placebos | Drug | Empty capsule with 250ml of distilled water |
|
| Services Institute of Medical Sciences, Services Hospital |
| Lahore |
| Punjab Province |
| 54600 |
| Pakistan |
| Oyero OG, Toyama M, Mitsuhiro N, Onifade AA, Hidaka A, Okamoto M, Baba M. SELECTIVE INHIBITION OF HEPATITIS C VIRUS REPLICATION BY ALPHA-ZAM, A NIGELLA SATIVA SEED FORMULATION. Afr J Tradit Complement Altern Med. 2016 Sep 29;13(6):144-148. doi: 10.21010/ajtcam.v13i6.20. eCollection 2016. |
| 29472785 | Background | Khan SU, Anjum SI, Rahman K, Ansari MJ, Khan WU, Kamal S, Khattak B, Muhammad A, Khan HU. Honey: Single food stuff comprises many drugs. Saudi J Biol Sci. 2018 Feb;25(2):320-325. doi: 10.1016/j.sjbs.2017.08.004. Epub 2017 Aug 16. |
| 25859296 | Background | Forouzanfar F, Bazzaz BS, Hosseinzadeh H. Black cumin (Nigella sativa) and its constituent (thymoquinone): a review on antimicrobial effects. Iran J Basic Med Sci. 2014 Dec;17(12):929-38. |
| 36420866 | Derived | Ashraf S, Ashraf S, Ashraf M, Imran MA, Kalsoom L, Siddiqui UN, Farooq I, Akmal R, Akram MK, Ashraf S, Ghufran M, Majeed N, Habib Z, Rafique S, -Abdin ZU, Arshad S, Shahab MS, Ahmad S, Zheng H, Mirza AR, Zulfiqar S, Anwar MI, Humayun A, Mahmud T, Saboor QA, Ahmad A, Ashraf M, Izhar M; DOCTORS LOUNGE consortium. Honey and Nigella sativa against COVID-19 in Pakistan (HNS-COVID-PK): A multicenter placebo-controlled randomized clinical trial. Phytother Res. 2023 Feb;37(2):627-644. doi: 10.1002/ptr.7640. Epub 2022 Nov 24. |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |