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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

Tracking Information
First Submitted Date  ICMJE February 20, 2021
First Posted Date  ICMJE February 23, 2021
Last Update Posted Date July 2, 2021
Actual Study Start Date  ICMJE March 5, 2021
Estimated Primary Completion Date February 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2021)		 SARS-CoV-2 infection rate [ Time Frame: 14 days ]
RT-PCR SARS-CoV-2
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Honey and Nigella Sativa in COVID-19 Prophylaxis
Official Title  ICMJE Honey and Nigella Sativa in the Prophylaxis of COVID-19: A Randomized Controlled Trial
Brief Summary Honey and Nigella sativa has established antiviral, antibacterial, anti-inflammatory, and immunomodulatory roles. So it is planned to test for its prophylaxis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Honey
    0.5 gm/Kg/day honey
  • Drug: Nigella sativa seed
    40 mg/Kg/day
  • Other: Placebo
    empty capsule with sugar water
Study Arms  ICMJE
  • Active Comparator: Honey and Nigella sativa Arm
    0.5 g/kg/day honey 40 mg/Kg/day Nigella sativa seeds
    Interventions:
    • Drug: Honey
    • Drug: Nigella sativa seed
  • Placebo Comparator: Placebo Arm
    empty capsule with sugar water
    Intervention: Other: Placebo
Publications * Ashraf S, Ashraf S, Akmal R, Ashraf M, Kalsoom L, Maqsood A, Imran MA, Farooq I, Ashraf S, Siddiqui UN, Ghufran M, Akram MK, Majeed N, Rafique S, Habib Z, Shahab MS, Akmal A, Shaukat Z, Abdin ZU, Khaqan A, Arshad S, Rehman Virk MA, Gul M, Awais AB, Hassan M, Khalid N, Iqbal QUA, Ahmad T, Akram M, Muhammad A, Khalil M, Aslam A, Umer M, Sherazi SSH, Safdar Z, Ahmad S, Bilal M, Zahid MN, Koshak AE, Hilal A, Malik AA, Iqbal U, Baig AA, Alahmadi YM, Humayun A, Malik A, Ahmad A, Ashraf M, Saboor QA, Izhar M; DOCTORS LOUNGE consortium. 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. Trials. 2021 Sep 15;22(1):618. doi: 10.1186/s13063-021-05510-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2021)		 1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2022
Estimated Primary Completion Date February 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Health care professionals Post-exposure COVID-19

Exclusion Criteria:

  • Multi-organ failure active COVID-19
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sohaib Ashraf, MBBS 8573167995 sohaib@skzmdc.edu.pk
Contact: Ahmad Imran, MBBS +923338110708 ahmad.imran@skzmdc.edu.pk
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04767087
Other Study ID Numbers  ICMJE SZMC/IRB/Internal/273/2021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sohaib Ashraf
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Sheikh Zayed Federal Postgraduate Medical Institute
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP