Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
313 participants
INTERVENTIONAL
2020-04-30
2020-08-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nigella Sativa & Honey Group
Drug: 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
Honey
1gm/Kg/Day
Nigella Sativa / Black Cumin
80mg/Kg/day
Standard Medical Care
Standard 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)
Placebos
Empty capsule with 250ml of distilled water
Interventions
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Honey
1gm/Kg/Day
Nigella Sativa / Black Cumin
80mg/Kg/day
Placebos
Empty capsule with 250ml of distilled water
Eligibility Criteria
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Inclusion Criteria
* Patients admitted in Corona centers
Exclusion Criteria
* Pregnant and lactating females.
* History of allergy to any drug being administered in this study
* Severely terminally ill patients
* Patients on Nil Per Oral
18 Years
ALL
No
Sponsors
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Sohaib Ashraf
OTHER
Responsible Party
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Sohaib Ashraf
Post-Graduate Resident Cardiology
Principal Investigators
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Shoaib Ashraf, PhD
Role: STUDY_DIRECTOR
Massachusetts General Hospital, Harvard Medical School, USA
Muhammad Ashraf, DVM, PhD
Role: STUDY_CHAIR
University Of Veterinary & Animal Sciences, Lahore
Sohaib Ashraf, MBBS
Role: PRINCIPAL_INVESTIGATOR
Federal Post-Graduate Medical Institute, Lahore
Muhammad Ahmad Imran, MBBS
Role: PRINCIPAL_INVESTIGATOR
Shaikh Zayed Hospital, Lahore
Ayesha Hamayun, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Shaikh Khalifa Bin Zayed Al-Nahyan Medical & Dental College, Lahore
Locations
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Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital
Lahore, Punjab Province, Pakistan
Services Institute of Medical Sciences, Services Hospital
Lahore, Punjab Province, Pakistan
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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IRB/2020/658/SIMS
Identifier Type: OTHER
Identifier Source: secondary_id
SZMC/IRB/Internal/0026/2020
Identifier Type: -
Identifier Source: org_study_id