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NCT Number: NCT04347382

Honey & Nigella Sativa Trial Against COVID-19

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).

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Key information

Conditions

Coronavirus Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital, Lahore, Punjab Province, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Honey

Drug

1gm/Kg/Day

Nigella Sativa / Black Cumin

Drug

80mg/Kg/day

Placebos

Drug

Empty capsule with 250ml of distilled water

Primary outcomes

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

    Time frame: upto max 14 days

  2. 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.

  3. 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.

  4. 30 day mortality

    Time frame: 30 days

    30 days mortality rate in each arm

  5. 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).

  6. Fever

    Time frame: 13 days

    Degree of fever

Secondary outcomes

  1. Oxygen Saturation at room air

    Time frame: upto max of 14 days

Sponsors and collaborators

Lead sponsor

Sohaib Ashraf

Other

Registry information

Official study title

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

Acronym: HNS-COVID-PK

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2020
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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