NCT04767087

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Mar 2021

Typical duration for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

March 5, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

July 2, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

February 20, 2021

Last Update Submit

July 1, 2021

Conditions

Keywords

HoneyNigella sativaProphylaxisCOVID-19Prophetic Medicine

Outcome Measures

Primary Outcomes (1)

  • SARS-CoV-2 infection rate

    RT-PCR SARS-CoV-2

    14 days

Study Arms (2)

Honey and Nigella sativa Arm

ACTIVE COMPARATOR

0.5 g/kg/day honey 40 mg/Kg/day Nigella sativa seeds

Drug: HoneyDrug: Nigella sativa seed

Placebo Arm

PLACEBO COMPARATOR

empty capsule with sugar water

Other: Placebo

Interventions

HoneyDRUG

0.5 gm/Kg/day honey

Honey and Nigella sativa Arm

40 mg/Kg/day

Honey and Nigella sativa Arm
PlaceboOTHER

empty capsule with sugar water

Placebo Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health care professionals Post-exposure COVID-19

You may not qualify if:

  • Multi-organ failure active COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaikh Zayed Post-Graduate Medical Institute

Lahore, MA, 54600, Pakistan

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19

Interventions

HoneyNigella sativa oil

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Sohaib Ashraf, MBBS

    Massachusetts General Hospital

    STUDY DIRECTOR
  • Muhammad Ashraf, PhD

    University of Veterinary and Animal Sciences

    STUDY CHAIR
  • Ahmad Imran, MBBS

    Shaikh Zayed Post-Graduate Medical Institute

    PRINCIPAL INVESTIGATOR
  • Moneeb Ashraf, MBBS

    King Edward Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sohaib Ashraf, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Registrar Cardiology

Study Record Dates

First Submitted

February 20, 2021

First Posted

February 23, 2021

Study Start

March 5, 2021

Primary Completion

February 15, 2022

Study Completion

April 15, 2022

Last Updated

July 2, 2021

Record last verified: 2021-07

Locations