Covid19Phase 2/3HNS-COVID-PKNCT04767087
Honey and Nigella Sativa in COVID-19 Prophylaxis
A Phase 2/3 study testing Honey and Nigella sativa seed in people with Covid19, run by Sohaib Ashraf at 1 site in Pakistan.
Trial summary
Honey and Nigella sativa has established antiviral, antibacterial, anti-inflammatory, and immunomodulatory roles. So it is planned to test for its prophylaxis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Honey and Nigella sativa seed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Mar 2021to 15 Apr 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health care professionals Post-exposure COVID-19
Who cannot join
- Multi-organ failure active COVID-19
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shaikh Zayed Post-Graduate Medical Institute
Lahore, MA, 54600
Sohaib Ashraf, MBBS, 03334474523, sohaib@skzmdc.edu.pk
Ahmad Imran, MBBS, +923338110708, ahmad.imran@skzmdc.edu.pk
About this study
Official title: Honey and Nigella Sativa in the Prophylaxis of COVID-19: A Randomized Controlled Trial
Honey and Nigella sativa has established antiviral, antibacterial, anti-inflammatory, and immunomodulatory roles. So it is planned to test for its prophylaxis
- Conditions
- Covid19
- Being tested
- Honey, Nigella sativa seed, Placebo
- Keywords
- Honey, Nigella sativa, Prophylaxis, COVID-19, Prophetic Medicine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoneyDrug
0.5 gm/Kg/day honey
Nigella sativa seedDrug
40 mg/Kg/day
PlaceboOther
empty capsule with sugar water
| Study group | Role | What they receive |
|---|---|---|
| Honey and Nigella sativa Arm | Active comparator | 0.5 g/kg/day honey 40 mg/Kg/day Nigella sativa seeds Receives: Drug: Honey; Drug: Nigella sativa seed |
| Placebo Arm | Placebo comparator | empty capsule with sugar water Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 infection rate
RT-PCR SARS-CoV-2
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start5 Mar 2021
- Primary completion15 Feb 2022 (estimated)
- Study completion15 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohaib Ashraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute
- Investigators
- Sohaib Ashraf, MBBS, Study director, Massachusetts General HospitalMuhammad Ashraf, PhD, Study chair, University of Veterinary and Animal SciencesAhmad Imran, MBBS, Principal investigator, Shaikh Zayed Post-Graduate Medical InstituteMoneeb Ashraf, MBBS, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767087
- Sponsor's protocol ID
- SZMC/IRB/Internal/273/2021
- Acronym
- HNS-COVID-PK
- Status last verified
- Jul 2021
- First submitted
- 20 Feb 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ashraf S, Ashraf S, Akmal R, Ashraf M, Kalsoom L, Maqsood A, Imran MA, Farooq I, Ashraf S, Siddiqui UN, Ghufran M, Akram MK, Majeed N, Rafique S, Habib Z, Shahab MS, Akmal A, Shaukat Z, Abdin ZU, Khaqan A, Arshad S, Rehman Virk MA, Gul M, Awais AB, Hassan M, Khalid N, Iqbal QUA, Ahmad T, Akram M, Muhammad A, Khalil M, Aslam A, Umer M, Sherazi SSH, Safdar Z, Ahmad S, Bilal M, Zahid MN, Koshak AE, Hilal A, Malik AA, Iqbal U, Baig AA, Alahmadi YM, Humayun A, Malik A, Ahmad A, Ashraf M, Saboor QA, Izhar M; DOCTORS LOUNGE consortium. Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Sep 15;22(1):618. doi: 10.1186/s13063-021-05510-3.
PubMed 34526081
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Honey and Nigella Sativa in the Prophylaxis of COVID-19: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04767087
- Acronym / sponsor ID
- HNS-COVID-PK / SZMC/IRB/Internal/273/2021
- Conditions
- Covid19
- Keywords
- Honey, Nigella sativa, Prophylaxis, COVID-19, Prophetic Medicine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sohaib AshrafUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 15 Apr 2022 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Honey and Nigella sativa has established antiviral, antibacterial, anti-inflammatory, and immunomodulatory roles. So it is planned to test for its prophylaxis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Honey and Nigella sativa Arm | Active comparator | Drug: Honey, Drug: Nigella sativa seed0.5 g/kg/day honey 40 mg/Kg/day Nigella sativa seeds |
| Placebo Arm | Placebo comparator | Other: Placeboempty capsule with sugar water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Health care professionals Post-exposure COVID-19
Key exclusion criteria (1 listed)
- Multi-organ failure active COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honey0.5 gm/Kg/day honey | Drug | Honey and Nigella sativa Arm |
| Nigella sativa seed40 mg/Kg/day | Drug | Honey and Nigella sativa Arm |
| Placeboempty capsule with sugar water | Other | Placebo Arm |
Primary outcome
SARS-CoV-2 infection rate
Time frame: 14 days
RT-PCR SARS-CoV-2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Derived from this study: PubMed 34526081Ashraf S, Ashraf S, Akmal R, Ashraf M, Kalsoom L, Maqsood A, Imran MA, Farooq I, Ashraf S, Siddiqui UN, Ghufran M, Akram MK, Majeed N, Rafique S, Habib Z, Shahab MS, Akmal A, Shaukat Z, Abdin ZU, Khaqan A, Arshad S, Rehman Virk MA, Gul M, Awais AB, Hassan M, Khalid N, Iqbal QUA, Ahmad T, Akram M, Muhammad A, Khalil M, Aslam A, Umer M, Sherazi SSH, Safdar Z, Ahmad S, Bilal M, Zahid MN, Koshak AE, Hilal A, Malik AA, Iqbal U, Baig AA, Alahmadi YM, Humayun A, Malik A, Ahmad A, Ashraf M, Saboor QA, Izhar M; DOCTORS LOUNGE consortium. Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Sep 15;22(1):618. doi: 10.1186/s13063-021-05510-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sohaib Ashraf, MBBS study director
Massachusetts General Hospital
Muhammad Ashraf, PhD study chair
University of Veterinary and Animal Sciences
Ahmad Imran, MBBS principal investigator
Shaikh Zayed Post-Graduate Medical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Honey and Nigella sativa seed in people with Covid19, run by Sohaib Ashraf at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohaib Ashraf, MBBS (8573167995, sohaib@skzmdc.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 infection rate (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.