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Coronavirus InfectionPhase 3HNS-COVID-PKNCT04347382

Honey & Nigella Sativa Trial Against COVID-19

A Phase 3 study testing Honey and Nigella Sativa / Black Cumin in people with Coronavirus Infection and Sars-CoV2, run by Sohaib Ashraf at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus Infection, Sars-CoV2
What is being tested?
Honey and Nigella Sativa / Black Cumin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
313 participants
Where
2 sitesPakistan
Study dates
30 Apr 2020to 30 Aug 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites

  • Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital

    Lahore, Punjab Province, 54600

  • Services Institute of Medical Sciences, Services Hospital

    Lahore, Punjab Province, 54600

Other trials in Pakistan

About this study

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

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).

Read the 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.

Being tested
Honey, Nigella Sativa / Black Cumin, Placebos
Keywords
SARS-CoV-2, COVID-19, Coronavirus, Honey, Nigella Sativa, Black Cummin, Herbal Medicine
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HoneyDrug

    1gm/Kg/Day

  • Nigella Sativa / Black CuminDrug

    80mg/Kg/day

  • PlacebosDrug

    Empty capsule with 250ml of distilled water

Study groups in NCT04347382
Study groupRoleWhat they receive
Nigella Sativa & Honey GroupExperimentalDrug: 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
Receives: Drug: Honey; Drug: Nigella Sativa / Black Cumin
Standard Medical CarePlacebo comparatorStandard 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)
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Days required to get a positive COVID-19 PCR to negative

    Measured: upto max 14 days

  2. Severity of symptoms progression

    Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe.

    Measured: upto max 14 days

  3. 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.

    Measured: upto max 14 day

  4. 30 day mortality

    30 days mortality rate in each arm

    Measured: 30 days

  5. 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).

    Measured: 0, 4, 6, 8, 10 and 12 day

  6. Fever

    Degree of fever

    Measured: 13 days

Secondary outcomes (1)

  1. Oxygen Saturation at room air

    Measured: upto max of 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study start30 Apr 2020
  3. Primary completion30 Aug 2020
  4. Study completion30 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04347382
Sponsor's protocol ID
SZMC/IRB/Internal/0026/2020
Other IDs
IRB/2020/658/SIMS
Acronym
HNS-COVID-PK
Status last verified
Nov 2020
First submitted
11 Apr 2020
Last updated
12 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24413991

  • 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.

    PubMed 28480371

  • 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.

    PubMed 29472785

  • 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.

    PubMed 25859296

  • Ashraf S, Ashraf S, Ashraf M, Imran MA, Kalsoom L, Siddiqui UN, Farooq I, Akmal R, Akram MK, Ashraf S, Ghufran M, Majeed N, Habib Z, Rafique S, -Abdin ZU, Arshad S, Shahab MS, Ahmad S, Zheng H, Mirza AR, Zulfiqar S, Anwar MI, Humayun A, Mahmud T, Saboor QA, Ahmad A, Ashraf M, Izhar M; DOCTORS LOUNGE consortium. Honey and Nigella sativa against COVID-19 in Pakistan (HNS-COVID-PK): A multicenter placebo-controlled randomized clinical trial. Phytother Res. 2023 Feb;37(2):627-644. doi: 10.1002/ptr.7640. Epub 2022 Nov 24.

    PubMed 36420866

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Honey and Nigella Sativa / Black Cumin in people with Coronavirus Infection and Sars-CoV2, run by Sohaib Ashraf at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days required to get a positive COVID-19 PCR to negative (time frame: upto max 14 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04347382, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.

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