Honey & Nigella Sativa Trial Against COVID-19

NCT04347382 | Completed Phase 3 DMC

• 2 other identifiers: SZMC/IRB/Internal/0026/2020IRB/2020/658/SIMS
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 2

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).

Conditions

Coronavirus Infection; Sars-CoV2

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Days required to get a positive COVID-19 PCR to negative

  upto max 14 days

• 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

• 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

• 30 day mortality

  30 days mortality rate in each arm

  30 days

• 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

• Fever

  Degree of fever

  13 days

Secondary Outcomes (1)

• Oxygen Saturation at room air

  upto max of 14 days

Study Arms (2)

Nigella Sativa & Honey Group

EXPERIMENTAL

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

Drug: Honey; Drug: Nigella Sativa / Black Cumin

Standard Medical Care

PLACEBO COMPARATOR

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)

Drug: Placebos

Interventions

Honey DRUG

1gm/Kg/Day

Nigella Sativa & Honey Group

Nigella Sativa / Black Cumin DRUG

80mg/Kg/day

Nigella Sativa & Honey Group

Placebos DRUG

Empty capsule with 250ml of distilled water

Standard Medical Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result with SSC-2 score\> 5
• Patients admitted in Corona centers

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohaib Ashraf: lead

Study Sites (2)

Federal Post-Graduate Medical Institute, Shaikh Zayed Hospital

Lahore, Punjab Province, 54600, Pakistan

Location

Services Institute of Medical Sciences, Services Hospital

Lahore, Punjab Province, 54600, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 24413991 BACKGROUND

• 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.

  PMID: 28480371 BACKGROUND

• 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.

  PMID: 29472785 BACKGROUND

• 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.

  PMID: 25859296 BACKGROUND

• 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.

  PMID: 36420866 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Honey

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Shoaib Ashraf, PhD

  Massachusetts General Hospital, Harvard Medical School, USA

  STUDY DIRECTOR

• Muhammad Ashraf, DVM, PhD

  University Of Veterinary & Animal Sciences, Lahore

  STUDY CHAIR

• Sohaib Ashraf, MBBS

  Federal Post-Graduate Medical Institute, Lahore

  PRINCIPAL INVESTIGATOR

• Muhammad Ahmad Imran, MBBS

  Shaikh Zayed Hospital, Lahore

  PRINCIPAL INVESTIGATOR

• Ayesha Hamayun, MBBS, PhD

  Shaikh Khalifa Bin Zayed Al-Nahyan Medical & Dental College, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post-Graduate Resident Cardiology

Study Record Dates

• First Submitted: April 11, 2020
• First Posted: April 15, 2020
• Study Start: April 30, 2020
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)