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

Primary Purpose

Coronavirus Infection, Sars-CoV2

Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Honey
Nigella Sativa / Black Cumin
Placebos
Sponsored by
Sohaib Ashraf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring SARS-CoV-2, COVID-19, Coronavirus, Honey, Nigella Sativa, Black Cummin, Herbal Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital
  • Services Institute of Medical Sciences, Services Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nigella Sativa & Honey Group

Standard Medical Care

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Days required to get a positive COVID-19 PCR to negative
Severity of symptoms progression
Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe.
Duration of Hospital Saty
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.
30 day mortality
30 days mortality rate in each arm
Clinical Grade Status
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).
Fever
Degree of fever

Secondary Outcome Measures

Oxygen Saturation at room air

Full Information

First Posted
April 11, 2020
Last Updated
November 9, 2020
Sponsor
Sohaib Ashraf
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1. Study Identification

Unique Protocol Identification Number
NCT04347382
Brief Title
Honey & Nigella Sativa Trial Against COVID-19
Acronym
HNS-COVID-PK
Official Title
The Role of Honey and Nigella Sativa in the Management of COVID-19; A Randomized Controlled, Open-label, Add-on Trial in Pakistan
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Sars-CoV2
Keywords
SARS-CoV-2, COVID-19, Coronavirus, Honey, Nigella Sativa, Black Cummin, Herbal Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nigella Sativa & Honey Group
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Medical Care
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Honey
Intervention Description
1gm/Kg/Day
Intervention Type
Drug
Intervention Name(s)
Nigella Sativa / Black Cumin
Intervention Description
80mg/Kg/day
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Empty capsule with 250ml of distilled water
Primary Outcome Measure Information:
Title
Days required to get a positive COVID-19 PCR to negative
Time Frame
upto max 14 days
Title
Severity of symptoms progression
Description
Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe.
Time Frame
upto max 14 days
Title
Duration of Hospital Saty
Description
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.
Time Frame
upto max 14 day
Title
30 day mortality
Description
30 days mortality rate in each arm
Time Frame
30 days
Title
Clinical Grade Status
Description
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).
Time Frame
0, 4, 6, 8, 10 and 12 day
Title
Fever
Description
Degree of fever
Time Frame
13 days
Secondary Outcome Measure Information:
Title
Oxygen Saturation at room air
Time Frame
upto max of 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shoaib Ashraf, PhD
Organizational Affiliation
Massachusetts General Hospital, Harvard Medical School, USA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Muhammad Ashraf, DVM, PhD
Organizational Affiliation
University Of Veterinary & Animal Sciences, Lahore
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sohaib Ashraf, MBBS
Organizational Affiliation
Federal Post-Graduate Medical Institute, Lahore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammad Ahmad Imran, MBBS
Organizational Affiliation
Shaikh Zayed Hospital, Lahore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayesha Hamayun, MBBS, PhD
Organizational Affiliation
Shaikh Khalifa Bin Zayed Al-Nahyan Medical & Dental College, Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54600
Country
Pakistan
Facility Name
Services Institute of Medical Sciences, Services Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54600
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24413991
Citation
Ulasli M, Gurses SA, Bayraktar R, Yumrutas O, Oztuzcu S, Igci M, Igci YZ, Cakmak EA, Arslan A. The effects of Nigella sativa (Ns), Anthemis hyalina (Ah) and Citrus sinensis (Cs) extracts on the replication of coronavirus and the expression of TRP genes family. Mol Biol Rep. 2014 Mar;41(3):1703-11. doi: 10.1007/s11033-014-3019-7. Epub 2014 Jan 12.
Results Reference
background
PubMed Identifier
28480371
Citation
Oyero OG, Toyama M, Mitsuhiro N, Onifade AA, Hidaka A, Okamoto M, Baba M. SELECTIVE INHIBITION OF HEPATITIS C VIRUS REPLICATION BY ALPHA-ZAM, A NIGELLA SATIVA SEED FORMULATION. Afr J Tradit Complement Altern Med. 2016 Sep 29;13(6):144-148. doi: 10.21010/ajtcam.v13i6.20. eCollection 2016.
Results Reference
background
PubMed Identifier
29472785
Citation
Khan SU, Anjum SI, Rahman K, Ansari MJ, Khan WU, Kamal S, Khattak B, Muhammad A, Khan HU. Honey: Single food stuff comprises many drugs. Saudi J Biol Sci. 2018 Feb;25(2):320-325. doi: 10.1016/j.sjbs.2017.08.004. Epub 2017 Aug 16.
Results Reference
background
PubMed Identifier
25859296
Citation
Forouzanfar F, Bazzaz BS, Hosseinzadeh H. Black cumin (Nigella sativa) and its constituent (thymoquinone): a review on antimicrobial effects. Iran J Basic Med Sci. 2014 Dec;17(12):929-38.
Results Reference
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Honey & Nigella Sativa Trial Against COVID-19

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