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Honey and Nigella Sativa in COVID-19 Prophylaxis (HNS-COVID-PK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04767087
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute

Study Description
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Brief Summary:
Honey and Nigella sativa has established antiviral, antibacterial, anti-inflammatory, and immunomodulatory roles. So it is planned to test for its prophylaxis

Condition or disease Intervention/treatment Phase
Covid19 Drug: Honey Drug: Nigella sativa seed Other: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Honey and Nigella Sativa in the Prophylaxis of COVID-19: A Randomized Controlled Trial
Actual Study Start Date : March 5, 2021
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : April 15, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Honey and Nigella sativa Arm
0.5 g/kg/day honey 40 mg/Kg/day Nigella sativa seeds
 Drug: Honey
0.5 gm/Kg/day honey

Drug: Nigella sativa seed
40 mg/Kg/day
Placebo Comparator: Placebo Arm
empty capsule with sugar water
 Other: Placebo
empty capsule with sugar water


Outcome Measures
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Primary Outcome Measures :
  1. SARS-CoV-2 infection rate [ Time Frame: 14 days ]
    RT-PCR SARS-CoV-2


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health care professionals Post-exposure COVID-19

Exclusion Criteria:

  • Multi-organ failure active COVID-19
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04767087


Contacts
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Contact: Sohaib Ashraf, MBBS 8573167995 sohaib@skzmdc.edu.pk
Contact: Ahmad Imran, MBBS +923338110708 ahmad.imran@skzmdc.edu.pk

Locations
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Pakistan
Shaikh Zayed Post-Graduate Medical Institute Recruiting
Lahore, MA, Pakistan, 54600
Contact: Sohaib Ashraf, MBBS    03334474523    sohaib@skzmdc.edu.pk   
Contact: Ahmad Imran, MBBS    +923338110708    ahmad.imran@skzmdc.edu.pk   
Principal Investigator: Iqra Farooq, MBBS         
Principal Investigator: Larab Kalsoom, MBBS         
Sub-Investigator: Shahroze Arshad, MBBS         
Sub-Investigator: Maaz Akram, MBBS         
Principal Investigator: Uzma N Siddique, MBBS         
Sponsors and Collaborators
Sohaib Ashraf
Investigators
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Study Director: Sohaib Ashraf, MBBS Massachusetts General Hospital
Study Chair: Muhammad Ashraf, PhD University of Veterinary and Animal Sciences
Principal Investigator: Ahmad Imran, MBBS Shaikh Zayed Post-Graduate Medical Institute
Principal Investigator: Moneeb Ashraf, MBBS King Edward Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sohaib Ashraf, Registrar Cardiology, Sheikh Zayed Federal Postgraduate Medical Institute
ClinicalTrials.gov Identifier: NCT04767087    
Other Study ID Numbers: SZMC/IRB/Internal/273/2021
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute:
Honey
Nigella sativa
Prophylaxis
COVID-19
Prophetic Medicine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases