Honey & Nigella Sativa Trial Against COVID-19 (HNS-COVID-PK)

Sohaib Ashraf

Status and phase: Completed; Phase 3

Conditions: Sars-CoV2; Coronavirus Infection

Treatments: Drug: Placebos; Drug: Honey; Drug: Nigella Sativa / Black Cumin

Study type: Interventional

Funder types: Other

Identifiers

NCT04347382

IRB/2020/658/SIMS (Other Identifier)

SZMC/IRB/Internal/0026/2020

Details and patient eligibility

About

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).

Full 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.

Enrollment: 313 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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313 participants in 2 patient groups, including a placebo group

Nigella Sativa & Honey Group

Experimental group

Description:

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

Treatment:

Drug: Nigella Sativa / Black Cumin

Drug: Honey

Standard Medical Care

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebos