Your browser doesn't support javascript.
loading
Therapeutic efficacy of Honey and Nigella sativa against COVID-19: A multi-center randomized controlled clinical trial (HNS-COVID-PK)
Sohaib Ashraf; Shoaib Ashraf; Moneeb Ashraf; Muhammad Ahmad Imran; Larab Kalsoom; Uzma Nasim Siddiqui; Iqra Farooq; Zaigham Habib; Sidra Ashraf; Muhammad Ghufran; Muhammad Kiwan Akram; Nighat Majeed; Zain ul Abdin; Rutaba Akmal; Sundas Rafique; Khawar Nawaz; Muhammad Ismail Khalid Yousaf; Sohail Ahmad; Muhammad Sarmad Shahab; Muhammad Faisal Nadeem; Abubakar Hilal; Arz Muhammad; Zeeshan Shoukat; Ayesha Khaqan; Kanwal Hayat; Shahroz Arshad; Muhammad Hassan; Abeer bin Awais; Abdur Rehman Virk; Ammara Ahmad; Tayyab Mughal; Muhammad Umer; Muhammad Suhail; Sibgha Zulfiqar; Saulat Sarfraz; Imran Anwar; Ayesha Humayun; Muhammad Azam; Hui Zheng; Amber Malik; Mahmood Ayyaz; Ali Ahmad; Talha Mahmud; Qazi Abdul Saboor; Muhammad Ashraf; Mateen Izhar.
Afiliação
  • Sohaib Ashraf; Shaikh Zayed Medical Complex, Lahore, Pakistan
  • Shoaib Ashraf; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
  • Moneeb Ashraf; Kingedward Medical University, Mayo Hospital, Lahore, Pakistan
  • Muhammad Ahmad Imran; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Larab Kalsoom; Services Institute of Medical Sciences, Lahore, Pakistan
  • Uzma Nasim Siddiqui; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Iqra Farooq; Services Institute of Medial Sciences, Lahore, Pakistan
  • Zaigham Habib; Tehsile Head Quarter, Ferozwala, Shaikhupura, Pakistan
  • Sidra Ashraf; University of Veterinary and Animal Sciences Lahore, Pakistan
  • Muhammad Ghufran; ESACHS (Empresa de Servico Externo de la Asociacion Chilena de Seguridad, Chile
  • Muhammad Kiwan Akram; University of Veterinary adn Animal Sciences, Lahore, Pakistan
  • Nighat Majeed; Services Institute of Medical Sciences, Lahore, Pakistan.
  • Zain ul Abdin; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.
  • Rutaba Akmal; Sahara Medical College, Narowal, Pakistan.
  • Sundas Rafique; Kingedward Medical University, Mayo Hospital, Lahore, Pakistan.
  • Khawar Nawaz; Sunny Downstate/Kings Country Medical Center, New York, USA
  • Muhammad Ismail Khalid Yousaf; University of Louisville, Kentucky, USA
  • Sohail Ahmad; University of Veterinary and Animal Sciences, Lahore, Pakistan
  • Muhammad Sarmad Shahab; Allied Hospital, Faisalabad Medical University, Faisalabad, Pakistan
  • Muhammad Faisal Nadeem; University of Veterinary and Animal Sciences, Lahore, Pakistan
  • Abubakar Hilal; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Arz Muhammad; Shaikh Zayed POST-Graduate Medical Complex, Lahore
  • Zeeshan Shoukat; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Ayesha Khaqan; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Kanwal Hayat; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Shahroz Arshad; Shaukat Khanum Hospital, Lahore, Pakistan
  • Muhammad Hassan; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Abeer bin Awais; Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan
  • Abdur Rehman Virk; Shaikh Zayed post-Graduate Medical Institute, Lahore, Pakistan.
  • Ammara Ahmad; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Tayyab Mughal; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Muhammad Umer; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Muhammad Suhail; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Sibgha Zulfiqar; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Saulat Sarfraz; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Imran Anwar; Shaikh Zayed Post-Graduate Medical Institution, Lahore, Pakistan
  • Ayesha Humayun; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Muhammad Azam; University of Veterinary and Animal Sciences, Lahore, Pakistan
  • Hui Zheng; Massachusetts General Hospital, Boston, MA, USA
  • Amber Malik; Evercare Hospital, Lahore, Pakistan
  • Mahmood Ayyaz; Services Institute of Medical Sciences, Lahore, Pakistan.
  • Ali Ahmad; Centre Hospitalier Universitaire (CHU) Sainte Justin/University of Montreal, Montreal, Canada.
  • Talha Mahmud; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Qazi Abdul Saboor; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
  • Muhammad Ashraf; University of Veterinary and Animal Sciences, Lahore, Pakistan
  • Mateen Izhar; Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan
Preprint em Inglês | medRxiv | ID: ppmedrxiv-20217364
ABSTRACT
BACKGROUNDNo definitive treatment exists for Coronavirus Disease 2019 (COVID-19). Honey and Nigella sativa (HNS) have established antiviral, antibacterial, anti-inflammatory and immunomodulatory properties. Hence, we investigated efficacy of HNS against COVID-19. wide METHODSWe conducted a multicenter, placebo-controlled, randomized clinical trial at 4 centers in Pakistan. RT-PCR confirmed COVID-19 adults showing moderate or severe disease were enrolled in the study. Patients presenting with multi-organ failure, ventilator support, and chronic diseases (except diabetes mellitus and hypertension) were excluded. Patients were randomly assigned in 11 ratio to receive either honey (1 gm/Kg/day) and Nigella sativa seeds (80 mg/Kg/day) or placebo up-to 13 days along with standard care. The outcomes included symptom alleviation, viral clearance, and a 30-day mortality in intention-to-treat population. This trial was registered with ClinicalTrials.gov, NCT04347382. RESULTSThree hundred and thirteen patients - 210 moderate and 103 severe - underwent randomization from April 30 to July 29, 2020. Among these, 107 were assigned to HNS whereas 103 to placebo for moderate cases. For severe cases, 50 were given HNS and 53 were given placebos. HNS resulted in [~]50% reduction in time taken to alleviate symptoms as compared to placebo (Moderate (4 versus 7 days), Hazard Ratio [HR] 6.11; 95% Confidence Interval [CI] 4.23-8.84, P<0.0001 and severe (6 versus 13 days) HR 4.04; 95% CI, 2.46-6.64, P<0.0001). HNS also cleared the virus 4 days earlier than placebo group in moderate (6 versus 10 days, HR 5.53; 95% CI 3.76-8.14, P<0.0001) and severe cases (8.5 versus 12 days, HR 4.32; 95% CI 2.62-7.13, P<0.0001). HNS further led to a better clinical score on day 6 with normal activity resumption in 63.6% versus 10.9% among moderate cases (OR 0.07; 95% CI 0.03-0.13, P<0.0001) and hospital discharge in 50% versus 2.8% in severe cases (OR 0.03; 95% CI 0.01-0.09, P<0.0001). In severe cases, mortality rate was four-fold lower in HNS group than placebo (4% versus 18.87%, OR 0.18; 95% CI 0.02-0.92, P=0.029). No HNS-related adverse effects were observed. CONCLUSIONHNS significantly improved symptoms, viral clearance and mortality in COVID-19 patients. Thus, HNS represents an affordable over the counter therapy and can either be used alone or in combination with other treatments to achieve potentiating effects against COVID-19. FUNDINGFunded by Smile Welfare Organization, Shaikh Zayed Medical Complex, and Services Institute of Medical Sciences.
Licença
cc_by
Texto completo: Disponível Coleções: Preprints Base de dados: medRxiv Tipo de estudo: Experimental_studies / Estudo prognóstico / Rct Idioma: Inglês Ano de publicação: 2020 Tipo de documento: Preprint
Texto completo: Disponível Coleções: Preprints Base de dados: medRxiv Tipo de estudo: Experimental_studies / Estudo prognóstico / Rct Idioma: Inglês Ano de publicação: 2020 Tipo de documento: Preprint
...