NCT04347382

Honey & Nigella Sativa Trial Against COVID-19

The Role of Honey and Nigella Sativa in the Management of COVID-19; A Randomized Controlled, Open-label, Add-on Trial in Pakistan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Sohaib Ashraf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Coronavirus Infection
• Sars-CoV2

Interventions

Type	Name	Description
DRUG	Honey	1gm/Kg/Day
DRUG	Nigella Sativa / Black Cumin	80mg/Kg/day
DRUG	Placebos	Empty capsule with 250ml of distilled water

Timeline

• Start date: 2020-04-30
• Primary completion: 2020-08-30
• Completion: 2020-08-30
• First posted: 2020-04-15
• Last updated: 2020-11-12

Locations

2 sites across 1 country: Pakistan