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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347382
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute

Brief Summary:
To evaluate the effectiveness of Nigella Sativa (1 gm seed powder in a capsule orally) and 30 ml of 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).

Condition or disease Intervention/treatment Phase
Coronavirus Infection Sars-CoV2 Drug: Honey Drug: Nigella Sativa / Black Cumin Drug: Placebos Phase 3

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. Investigators will follow up with participants every 4th day to access clinically the severity of symptoms along with RT-PCR and HRCT chest or X-ray to access the disease progression.Those positive on 8th day will be followed up further for monitoring of primary end points. Findings of this trial are expected to help establishing a new remedy for the treatment of this pandemic giving mortality benefit along with earlier decrease in viral load and lesser complications rate caused by SARS-Cov-2 virus

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 30, 2020
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


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 1mg/kg/day orally upto a max of 14 days)

along with standard medical care

Drug: Honey
1mg/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




Primary Outcome Measures :
  1. Days required to get a positive COVID-19 PCR to negative [ Time Frame: upto max 14 days ]
    RT-PCR will be done on admission day (0 day) and then after every 4th day for 14 days or till the symptoms resolved and RT-PCR gets negative. RT-PCR will only be shown as positive or negative (as per limitation of Pakistan).

  2. HRCT/ X-ray findings of disease progression [ Time Frame: upto max 14 days ]
    HRCT will be conducted at admission day (0-day) and a total of maximum four CT-scan will be conducted after every 4th day. The minimum and score at which we label covid-19 positive will be 5 and 25 respectively using internationally standard nomenclature as described by Fleischner Society glossary and peer-reviewed literature on viral pneumonia.

  3. 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.

  4. 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.

  5. 30 day mortality [ Time Frame: 30 days ]
    30 days mortality rate in each arm


Secondary Outcome Measures :
  1. Oxygen Saturation at room air [ Time Frame: upto max of 14 days ]
    every 4th day oxygen saturation at room air will be checked to evaluate the disease progression

  2. Incidence of viral myocarditis [ Time Frame: upto max 14 days ]
    Involvement of cardiac complications will be assessed

  3. Incidence of Acute respiratory Distress Syndrome [ Time Frame: upto max 14 days ]
    Lethal complication like ARDS will be assessed to evaluate disease severity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347382


Locations
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Pakistan
Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital
Lahore, Punjab, Pakistan, 54600
Services Institute of Medical Sciences, Services Hospital
Lahore, Punjab, Pakistan, 54600
Sponsors and Collaborators
Sohaib Ashraf
Investigators
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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:
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Responsible Party: Sohaib Ashraf, Post-Graduate Resident Cardiology, Sheikh Zayed Federal Postgraduate Medical Institute
ClinicalTrials.gov Identifier: NCT04347382    
Other Study ID Numbers: SZMC/IRB/Internal/0026/2020
IRB/2020/658/SIMS ( Other Identifier: Services Institute of Medical Sciences, Services Hospital, Lahore, Pakistan )
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute:
SARS-CoV-2
COVID-19
Coronavirus
Honey
Nigella Sativa
Black Cummin
Herbal Medicine
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases