Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial.
| Title: | Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial. |
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| Authors: | Ashraf S; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. sohaib-ashraf@outlook.com.; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, USA. sohaib-ashraf@outlook.com.; Ashraf S; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, USA. shoaib.ashraf@mail.mcgill.ca.; Department of Pathobiology, Riphah International, Lahore, Pakistan. shoaib.ashraf@mail.mcgill.ca.; Akmal R; Department of Internal Medicine, Sahara Medical College, Narowal, Pakistan. rutabaakmal@gmail.com.; Ashraf M; Department of Pharmacology, Mayo Hospital, Kingedward Medical University, Lahore, Pakistan. moneeb.ashraf@hotmail.com.; Kalsoom L; Department of Medicine, Services Institute of Medical Sciences, Lahore, Pakistan. larab.kalsoom@outlook.com.; Maqsood A; Department of Pulmonary & Critical Care Medicine, University of Toledo Medical Center, Toledo, Ohio, USA. aadil.maqsood@utoledo.edu.; Imran MA; Department of Microbiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. ahmad.imran@skzmdc.edu.pk.; Farooq I; Department of Paediatric Surgery, Children Hospital, Lahore, Pakistan. iqrafarooq93@gmail.com.; Ashraf S; Institute of Biochemistry and Biotechnology, University of Veterinary and Animal Sciences, Lahore, Pakistan. sidra.ashraf@uvas.edu.pk.; Siddiqui UN; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. uzmamamoon@gmail.com.; Ghufran M; ESACHS (Empresa de Servicio Externo de la Asociación Chilena de Seguridad), Punta Arenas, Chile.; Akram MK; Department of Animal Nutrition, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Majeed N; Department of Internal Medicine, Services Institute of Medical Sciences, Lahore, Pakistan.; Rafique S; Department of Radiotherapy, Mayo Hospital, King Edward Medical University, Lahore, Pakistan.; Habib Z; Department of Orthopedics, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Shahab MS; Department of Internal Medicine, Allied Hospital, Faisalabad Medical University, Faisalabad, Pakistan.; Akmal A; Department of Surgery, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Shaukat Z; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Abdin ZU; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Khaqan A; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Arshad S; Department of Microbiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Rehman Virk MA; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Gul M; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Awais AB; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Hassan M; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Khalid N; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Iqbal QUA; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Ahmad T; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Akram M; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Muhammad A; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Khalil M; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Aslam A; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Umer M; Department of Gastroenterology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Sherazi SSH; Department of Pharmacology and Toxicology, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Safdar Z; Department of Pharmacology and Toxicology, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Ahmad S; Department of Department of Poultry Production, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Bilal M; Department of Animal Science, McGill University, Sainte-Anne-de-Bellevue, Quebec, Canada.; Zahid MN; Department of Biology, college of Science, University of Bahrain, Sakhir, Kingdom of Bahrain.; Koshak AE; Department of Natural Products and Alternative Medicine, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.; Hilal A; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Malik AA; Department of Family and Community Medicine, Rabigh Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.; Iqbal U; Global Health and Development Department, College of Public Health, Taipei Medical University, Taipei, Taiwan.; Baig AA; Unit of Biochemistry, Faculty of Medicine, University Sultan Zainal Abidin, Terengganu, Malaysia.; Alahmadi YM; Clinical and Hospital Pharmacy Department, College of Pharmacy, Taibah University Medina, Medina, Kingdom of Saudi Arabia.; Humayun A; Department of Community Medicine and Public Health|, Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan.; Malik A; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Ahmad A; Department of Microbiology, Infectiology and Immunology, Centre Hospitalier Universitaire (CHU) Sainte Justin/University of Montreal, Montreal, Canada.; Ashraf M; Department of Department of Poultry Production, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Saboor QA; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Izhar M; Department of Microbiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. mateen@cantab.net. |
| Corporate Authors: | DOCTORS LOUNGE consortium |
| Source: | Trials [Trials] 2021 Sep 15; Vol. 22 (1), pp. 618. Date of Electronic Publication: 2021 Sep 15. |
| Publication Type: | Clinical Trial Protocol; Letter |
| Language: | English |
| Journal Info: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BioMed Central, 2006- |
| MeSH Terms: | COVID-19* ; Honey* ; Nigella sativa*; Adult ; Hospitals ; Humans ; Randomized Controlled Trials as Topic ; SARS-CoV-2 ; Treatment Outcome ; Adaptive Clinical Trials as Topic ; Equivalence Trials as Topic |
| Abstract: | Objectives: Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS.; Trial Design: The study is a randomized, placebo-controlled, adaptive clinical trial with parallel group design, superiority framework with an allocation ratio of 1:1 among experimental (HNS) and placebo group. An interim analysis will be done when half of the patients have been recruited to evaluate the need to adapt sample size, efficacy, and futility of the trial.; Participants: All asymptomatic patients with hospital or community based COVID-19 exposure will be screened if they have had 4 days exposure to a confirmed case. Non-pregnant adults with significant exposure level will be enrolled in the study High-risk exposure (10min without face protection) Moderate exposure (10min with face protection) Subjects with acute or chronic infection, COVID-19 vaccinated, and allergy to HNS will be excluded from the study. Recruitment will be done at Shaikh Zayed Post-Graduate Medical Institute, Ali Clinic and Doctors Lounge in Lahore (Pakistan).; Intervention and Comparator: In this clinical study, patients will receive either raw natural honey (0.5 g) and encapsulated organic Nigella sativa seeds (40 mg) per kg body weight per day or empty capsule with and 30 ml of 5% dextrose water as a placebo for 14 days. Both the natural products will be certified for standardization by Government College University (Botany department). Furthermore, each patient will be given standard care therapy according to version 3.0 of the COVID-19 clinical management guidelines by the Ministry of National Health Services of Pakistan.; Main Outcomes: Primary outcome will be Incidence of COVID-19 cases within 14 days of randomisation. Secondary endpoints include incidence of COVID-19-related symptoms, hospitalizations, and deaths along with the severity of COVID-19-related symptoms till 14th day of randomization.; Randomisation: Participants will be randomized into experimental and control groups (1:1 allocation ratio) via the lottery method. There will be stratification based on high risk and moderate risk exposure.; Blinding (masking): Quadruple blinding will be ensured for the participants, care providers and outcome accessors. Data analysts will also be blinded to avoid conflict of interest. Site principal investigator will be responsible for ensuring masking.; Numbers to Be Randomised (sample Size): 1000 participants will be enrolled in the study with 1:1 allocation.; Trial Status: The final protocol version 1.4 was approved by institutional review board of Shaikh Zayed Post-Graduate Medical Complex on February 15, 2021. The trial recruitment was started on March 05, 2021, with a trial completion date of February 15, 2022.; Trial Registration: Clinical trial was registered on February 23, 2021, www.clinicaltrials.gov with registration ID NCT04767087 .; Full Protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.; (© 2021. The Author(s).) |
| Contributed Indexing: | Investigator: A Muhammad; K Hayat; G Amjad; M Kousar; U Hafeez; T Mughal; T Muzafar; S Zulfiqar; SS Alam; MI Anwar; A Malik; T Mahmud; A Arshad; K Nawaz; MIK Yousaf; Keywords: COVID-19; Honey; Nigella Sativa; Pakistan; Prophetic Medicine; Protocol; Randomised controlled trial |
| Molecular Sequence: | ClinicalTrials.gov NCT04767087 |
| Entry Date(s): | Date Created: 20210916 Date Completed: 20210917 Latest Revision: 20260109 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC8441040 |
| DOI: | 10.1186/s13063-021-05510-3 |
| PMID: | 34526081 |
| Database: | MEDLINE |
Clinical Trial Protocol; Letter