Honey and Nigella sativa against COVID-19 in Pakistan (HNS-COVID-PK): A multicenter placebo-controlled randomized clinical trial.
| Title: | Honey and Nigella sativa against COVID-19 in Pakistan (HNS-COVID-PK): A multicenter placebo-controlled randomized clinical trial. |
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| Authors: | Ashraf S; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Ashraf S; Department of Pathobiology, Riphah University, Lahore, Pakistan.; Ashraf M; Department of Pharmacology, King Edward Medical University, Mayo Hospital, Lahore, Pakistan.; Imran MA; Department of Microbiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Kalsoom L; Department of Internal Medicine, Services Institute of Medical Sciences, Lahore, Pakistan.; Siddiqui UN; Department of Medicine, Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia.; Department of Internal Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Farooq I; Department of Pediatrics Surgery, Children Hospital, Lahore, Pakistan.; Akmal R; Department of Medicine, Sahara Medical College, Narowal, Pakistan.; Akram MK; Department of Nutrition, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Ashraf S; Department of Biochemistry, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Ghufran M; Medico Cirujano, ESACHS (Empresa de Servico Externo de la Asociacion Chilena de Seguridad), Santiago, Chile.; Majeed N; Department of Internal Medicine, Services Institute of Medical Sciences, Lahore, Pakistan.; Habib Z; Department of Orthopedics, Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan.; Rafique S; Department of Oncology, Mayo Hospital, King Edward Medical University, Lahore, Pakistan.; -Abdin ZU; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Arshad S; Department of Internal Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Shahab MS; Department of Internal Medicine, Allied Hospital, Faisalabad Medical University, Faisalabad, Pakistan.; Ahmad S; Department of Poultry Production, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Zheng H; Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.; Mirza AR; Department of Plastic Surgery, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Zulfiqar S; Department of Physiology, Shaikh Khalifa Bin Zayed Al-Nahyan Medical and Dental College, Lahore, Pakistan.; Anwar MI; Department of General Surgery, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Humayun A; Department of Public Health and Community Medicine, Shaikh Zayed Postgraduate Medical Institute Lahore, Pakistan.; Mahmud T; Department of Pulmonology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Saboor QA; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Ahmad A; Department of Microbiology, Infectious Diseases & Immunology, Centre Hospitalier Universitaire (CHU) Sainte Justine/University of Montreal, Montreal, Quebec, Canada.; Ashraf M; Department of Pharmacology and Toxicology, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Izhar M; Department of Microbiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. |
| Corporate Authors: | DOCTORS LOUNGE consortium |
| Source: | Phytotherapy research : PTR [Phytother Res] 2023 Feb; Vol. 37 (2), pp. 627-644. Date of Electronic Publication: 2022 Nov 24. |
| Publication Type: | Randomized Controlled Trial; Multicenter Study; Journal Article |
| Language: | English |
| Journal Info: | Publisher: Wiley Country of Publication: England NLM ID: 8904486 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1099-1573 (Electronic) Linking ISSN: 0951418X NLM ISO Abbreviation: Phytother Res Subsets: MEDLINE |
| Imprint Name(s): | Publication: : Chichester : Wiley; Original Publication: London : Heyden & Son, c1987- |
| MeSH Terms: | COVID-19* ; Nigella sativa* ; Honey*; Pakistan/epidemiology ; Adult ; Humans ; SARS-CoV-2 ; Treatment Outcome |
| Abstract: | Until now, no specific and effective treatment exists for coronavirus disease 2019 (COVID-19). Since honey and Nigella sativa (HNS) have established antiviral, antibacterial, antiinflammatory, antioxidant, and immunomodulatory properties, we tested their efficacy for this disease in a multicenter, placebo-controlled, and randomized clinical trial at four medical care facilities in Pakistan. RT-PCR confirmed COVID-19 adults showing moderate or severe disease were enrolled in the trial. Patients were randomly assigned in a 1:1 ratio to receive either honey (1 g kg-1 day-1 ) and Nigella sativa seeds (80 mg kg-1 day-1 ) or a placebo for up to 13 days along with standard care. The outcomes included symptoms' alleviation, viral clearance, and 30-day mortality in the intention-to-treat population. Three hundred and thirteen patients, 210 with moderate and 103 with severe disease, underwent randomization from April 30 to July 29, 2020. Among the moderate cases, 107 were assigned to HNS, whereas 103 were assigned to the placebo group. Among the severe cases, 50 were given HNS, and 53 were given the placebo. HNS resulted in ~50% reduction in time taken to alleviate symptoms as compared to placebo (moderate cases: 4 vs. 7 days, Hazard Ratio [HR]: 6.11; 95% Confidence Interval [CI]: 4.23-8.84, p |
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| Contributed Indexing: | Keywords: COVID-19; SARS-CoV-2; black cumin; honey; nigella sativa; randomized controlled trial |
| Molecular Sequence: | ClinicalTrials.gov NCT04347382 |
| Entry Date(s): | Date Created: 20221124 Date Completed: 20230222 Latest Revision: 20230222 |
| Update Code: | 20260130 |
| DOI: | 10.1002/ptr.7640 |
| PMID: | 36420866 |
| Database: | MEDLINE |
Randomized Controlled Trial; Multicenter Study; Journal Article