Honey & Nigella Sativa Trial Against COVID-19

Coronavirus Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347382
• Other study ID #: SZMC/IRB/Internal/0026/2020
• Secondary ID: IRB/2020/658/SIM
• Status: Completed
• Phase: Phase 3
• Start date: April 30, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: November 2020
• Source: Sheikh Zayed Federal Postgraduate Medical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Sars-CoV2
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Honey
1gm/Kg/Day
• Nigella Sativa / Black Cumin
80mg/Kg/day
• Placebos
Empty capsule with 250ml of distilled water

Locations

Country	Name	City	State
Pakistan	Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital	Lahore	Punjab
Pakistan	Services Institute of Medical Sciences, Services Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Sohaib Ashraf

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days required to get a positive COVID-19 PCR to negative		upto max 14 days
Primary	Severity of symptoms progression	Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe.	upto max 14 days
Primary	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.	upto max 14 day
Primary	30 day mortality	30 days mortality rate in each arm	30 days
Primary	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).	0, 4, 6, 8, 10 and 12 day
Primary	Fever	Degree of fever	13 days
Secondary	Oxygen Saturation at room air		upto max of 14 days