Back to resultsHoney and Nigella Sativa in COVID-19 Prophylaxis (HNS-COVID-PK)
Primary Purpose
Covid19
Status
Unknown status
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Honey
Nigella sativa seed
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring Honey, Nigella sativa, Prophylaxis, COVID-19, Prophetic Medicine
Eligibility Criteria
Inclusion Criteria:
- Health care professionals Post-exposure COVID-19
Exclusion Criteria:
- Multi-organ failure active COVID-19
Sites / Locations
- Shaikh Zayed Post-Graduate Medical InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Honey and Nigella sativa Arm
Placebo Arm
Arm Description
0.5 g/kg/day honey 40 mg/Kg/day Nigella sativa seeds
empty capsule with sugar water
Outcomes
Primary Outcome Measures
SARS-CoV-2 infection rate
RT-PCR SARS-CoV-2
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04767087
Brief Title
Honey and Nigella Sativa in COVID-19 Prophylaxis
Acronym
HNS-COVID-PK
Official Title
Honey and Nigella Sativa in the Prophylaxis of COVID-19: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Anticipated)
Study Completion Date
April 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sohaib Ashraf
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Honey and Nigella sativa has established antiviral, antibacterial, anti-inflammatory, and immunomodulatory roles. So it is planned to test for its prophylaxis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Honey, Nigella sativa, Prophylaxis, COVID-19, Prophetic Medicine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Honey and Nigella sativa Arm
Arm Type
Active Comparator
Arm Description
0.5 g/kg/day honey 40 mg/Kg/day Nigella sativa seeds
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
empty capsule with sugar water
Intervention Type
Drug
Intervention Name(s)
Honey
Intervention Description
0.5 gm/Kg/day honey
Intervention Type
Drug
Intervention Name(s)
Nigella sativa seed
Intervention Description
40 mg/Kg/day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
empty capsule with sugar water
Primary Outcome Measure Information:
Title
SARS-CoV-2 infection rate
Description
RT-PCR SARS-CoV-2
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Health care professionals Post-exposure COVID-19
Exclusion Criteria:
Multi-organ failure active COVID-19
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sohaib Ashraf, MBBS
Phone
8573167995
Email
sohaib@skzmdc.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Imran, MBBS
Phone
+923338110708
Email
ahmad.imran@skzmdc.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sohaib Ashraf, MBBS
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Muhammad Ashraf, PhD
Organizational Affiliation
University of Veterinary and Animal Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmad Imran, MBBS
Organizational Affiliation
Shaikh Zayed Post-Graduate Medical Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moneeb Ashraf, MBBS
Organizational Affiliation
King Edward Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaikh Zayed Post-Graduate Medical Institute
City
Lahore
State/Province
MA
ZIP/Postal Code
54600
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohaib Ashraf, MBBS
Phone
03334474523
Email
sohaib@skzmdc.edu.pk
First Name & Middle Initial & Last Name & Degree
Ahmad Imran, MBBS
Phone
+923338110708
Email
ahmad.imran@skzmdc.edu.pk
First Name & Middle Initial & Last Name & Degree
Iqra Farooq, MBBS
First Name & Middle Initial & Last Name & Degree
Larab Kalsoom, MBBS
First Name & Middle Initial & Last Name & Degree
Shahroze Arshad, MBBS
First Name & Middle Initial & Last Name & Degree
Maaz Akram, MBBS
First Name & Middle Initial & Last Name & Degree
Uzma N Siddique, MBBS
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34526081
Citation
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.
Results Reference
derived
Learn more about this trial
Honey and Nigella Sativa in COVID-19 Prophylaxis
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