Honey & Nigella Sativa Trial Against COVID-19

NCT ID: NCT04347382

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronavirus Infection Sars-CoV2

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

SARS-CoV-2 COVID-19 Coronavirus Honey Nigella Sativa Black Cummin Herbal Medicine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Honey

Intervention Type DRUG

1gm/Kg/Day

Nigella Sativa / Black Cumin

Intervention Type DRUG

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)

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Empty capsule with 250ml of distilled water

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Honey

1gm/Kg/Day

Intervention Type DRUG

Nigella Sativa / Black Cumin

80mg/Kg/day

Intervention Type DRUG

Placebos

Empty capsule with 250ml of distilled water

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohaib Ashraf

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sohaib Ashraf

Post-Graduate Resident Cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Explore where the study is taking place and check the recruitment status at each participating site.

Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital

Lahore, Punjab Province, Pakistan

Site Status

Services Institute of Medical Sciences, Services Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24413991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28480371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29472785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25859296 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36420866 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB/2020/658/SIMS

Identifier Type: OTHER

Identifier Source: secondary_id

SZMC/IRB/Internal/0026/2020

Identifier Type: -

Identifier Source: org_study_id