Coronavirus Infection Clinical Trial
— HNS-COVID-PKOfficial title:
The Role of Honey and Nigella Sativa in the Management of COVID-19; A Randomized Controlled, Open-label, Add-on Trial in Pakistan
Verified date | November 2020 |
Source | Sheikh Zayed Federal Postgraduate Medical Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Sohaib Ashraf |
Pakistan,
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
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 |
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