Clinical trial NCT04347382: Honey & Nigella Sativa Trial Against COVID-19
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronavirus Infection
Sars-CoV2
Keywords: SARS-CoV-2
COVID-19
Coronavirus
Honey
Nigella Sativa
Black Cummin
Herbal Medicine
Lead sponsor: Sheikh Zayed Federal Postgraduate Medical Institute
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Days required to get a positive COVID-19 PCR to negative
timeFrame: upto max 14 days
measure: Severity of symptoms progression
timeFrame: upto max 14 days
measure: Duration of Hospital Saty
timeFrame: upto max 14 day
measure: 30 day mortality
timeFrame: 30 days
measure: Clinical Grade Status
timeFrame: 0, 4, 6, 8, 10 and 12 day
measure: Fever
timeFrame: 13 days
Secondary outcomes:
measure: Oxygen Saturation at room air
timeFrame: upto max of 14 days
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital
state: Punjab
city: Lahore
country: Pakistan
facility: Services Institute of Medical Sciences, Services Hospital
state: Punjab
Study officials:
affiliation: Massachusetts General Hospital, Harvard Medical School, USA
name: Shoaib Ashraf, PhD
role: STUDY_DIRECTOR
affiliation: University Of Veterinary & Animal Sciences, Lahore
name: Muhammad Ashraf, DVM, PhD
role: STUDY_CHAIR
affiliation: Federal Post-Graduate Medical Institute, Lahore
name: Sohaib Ashraf, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaikh Zayed Hospital, Lahore
name: Muhammad Ahmad Imran, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaikh Khalifa Bin Zayed Al-Nahyan Medical & Dental College, Lahore
name: Ayesha Hamayun, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.