Honey & Nigella Sativa Trial Against COVID-19 (HNS-COVID-PK)

November 9, 2020 updated by: Sohaib Ashraf

The Role of Honey and Nigella Sativa in the Management of COVID-19; A Randomized Controlled, Open-label, Add-on Trial in Pakistan

To evaluate the effectiveness of Nigella Sativa and honey stirred in 250 ml of distilled water 12 hourly till patient becomes asymptomatic or a maximum of 14 days with standard hospital care versus standard hospital care alone with placebo capsule and 250 ml water, in clearing the COVID-19 nucleic acid from throat and nasal swab, lowering disease detrimental effects on HRCT chest/X-ray and severity of symptoms along with duration of hospital stay till day 14th day of follow up and 30 days mortality (primary outcomes).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This cohort, adaptive, randomized, double armed group, controlled, Investigator Initiated interventional study is designed to demonstrate the superiority of a combination of black cumin with honey over standard care in SARS-CoV-2 (COVID-19) infected patients who consent to randomization following a new diagnosis in Pakistan with an SSC-2 score of > 5 with positive RT-PCR of COVID-19.

Study Type

Interventional

Enrollment (Actual)

313

Phase

  • 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 Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54600
        • Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital
      • Lahore, Punjab, Pakistan, 54600
        • Services Institute Of Medical Sciences, Services Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result with SSC-2 score> 5
  • Patients admitted in Corona centers

Exclusion Criteria:

  • Participants not giving consent.
  • Pregnant and lactating females.
  • History of allergy to any drug being administered in this study
  • Severely terminally ill patients
  • Patients on Nil Per Oral

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nigella Sativa & Honey Group

Drug: Nigella Sativa seed Powder 80 mg/Kg/day grinded in capsule upto a max of 14 days) Drug: Natural Honey 1gm/kg/day orally upto a max of 14 days)

along with standard medical care
Drug: Honey
1gm/Kg/Day
Drug: Nigella Sativa / Black Cumin
80mg/Kg/day
Placebo Comparator: Standard Medical Care
Standard supportive medical care prescribed by treating physician, Lahore which includes standard symptomatic care along with use of antibacterial or antiviral (if advised by pulmonologist or infectious disease specialist)
Drug: Placebos
Empty capsule with 250ml of distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days required to get a positive COVID-19 PCR to negative
Time Frame: upto max 14 days
upto max 14 days
Severity of symptoms progression
Time Frame: upto max 14 days
Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe.
upto max 14 days
Duration of Hospital Saty
Time Frame: upto max 14 day
Duration of hospital stay would be categorized as the number of days the patient stayed in the ward during treatment. The date of admission and date of discharge would give us total duration of stay.
upto max 14 day
30 day mortality
Time Frame: 30 days
30 days mortality rate in each arm
30 days
Clinical Grade Status
Time Frame: 0, 4, 6, 8, 10 and 12 day
grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death).
0, 4, 6, 8, 10 and 12 day
Fever
Time Frame: 13 days
Degree of fever
13 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Oxygen Saturation at room air
Time Frame: upto max of 14 days
upto max of 14 days

Collaborators and Investigators

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

Sponsor

Sohaib Ashraf

Investigators

  • Study Director: Shoaib Ashraf, PhD, Massachusetts General Hospital, Harvard Medical School, USA
  • Study Chair: Muhammad Ashraf, DVM, PhD, University of Veterinary & Animal Sciences, Lahore
  • Principal Investigator: Sohaib Ashraf, MBBS, Federal Post-Graduate Medical Institute, Lahore
  • Principal Investigator: Muhammad Ahmad Imran, MBBS, Shaikh Zayed Hospital, Lahore
  • Principal Investigator: Ayesha Hamayun, MBBS, PhD, Shaikh Khalifa Bin Zayed Al-Nahyan Medical & Dental College, Lahore

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)

April 30, 2020

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

August 30, 2020

Study Registration Dates

First Submitted

April 11, 2020

First Submitted That Met QC Criteria

April 11, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZMC/IRB/Internal/0026/2020
  • IRB/2020/658/SIMS (Other Identifier: Services Institute of Medical Sciences, Services Hospital, Lahore, Pakistan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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