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

July 1, 2021 updated by: Sohaib Ashraf

Honey and Nigella Sativa in the Prophylaxis of COVID-19: A Randomized Controlled Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • MA
      • Lahore, MA, Pakistan, 54600
        • Recruiting
        • Shaikh Zayed Post-Graduate Medical Institute
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Health care professionals Post-exposure COVID-19

Exclusion Criteria:

  • Multi-organ failure active COVID-19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 infection rate
Time Frame: 14 days
RT-PCR SARS-CoV-2
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohaib Ashraf

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Anticipated)

February 15, 2022

Study Completion (Anticipated)

April 15, 2022

Study Registration Dates

First Submitted

February 20, 2021

First Submitted That Met QC Criteria

February 20, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZMC/IRB/Internal/273/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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