Omega-3, Nigella Sativa, Indian Costus, Quinine, Anise Seed, Deglycyrrhizinated Licorice, Artemisinin, Febrifugine on Immunity of Patients With (COVID-19)
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ClinicalTrials.gov Identifier: NCT04553705 |
Recruitment Status :
Completed
First Posted : September 17, 2020
Last Update Posted : July 19, 2022
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Tracking Information | |||||||||||||
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First Submitted Date ICMJE | September 15, 2020 | ||||||||||||
First Posted Date ICMJE | September 17, 2020 | ||||||||||||
Last Update Posted Date | July 19, 2022 | ||||||||||||
Actual Study Start Date ICMJE | September 20, 2020 | ||||||||||||
Actual Primary Completion Date | November 4, 2020 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Omega-3, Nigella Sativa, Indian Costus, Quinine, Anise Seed, Deglycyrrhizinated Licorice, Artemisinin, Febrifugine on Immunity of Patients With (COVID-19) | ||||||||||||
Official Title ICMJE | Impact of Different Treatment Modalities on Immunity Against COVID-19 | ||||||||||||
Brief Summary | The first version of this preprint article is registered on the 4th of May 2020 under the digital object identifier of:10.31219/osf.io/u56fc. COVID-19 infections virus spread worldwide and impact many countries with sever economical sequences. The effective antiviral medication or vaccination for the virus is unavailable until the present date and it takes months or years to discover the effective treatment or test the efficacy of the discovered treatment. Based on these facts, the human immune system against the virus may have an effective role to regulate the infection and reduce the mortality rate among the infected patients. This proposed research article aims to explore the available medication/ natural supplementation to boost the immunity system of the patients against COVID-19 infections and reduce the mortality rate among infected patients. Methods: a proposed clinical trial will be carried out to investigate the effect of the different treatment modalities on the human immune system against COVID-19 infection. |
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Detailed Description | Natural supplementations have many reported effects on the human health ranged from immunity boosting to effective antiviral effect. Omeg-3 as an example affect the human health by many mechanisms e.g. Anti-oxidant, immunity boosting agent. Moreover, Omega-3 exerts an antiviral effect on Flu virus by inhibiting influenza virus replication 1. On the other hand, black seed supplementation exerts a chelation effect on sickle cell anemia patients and inhibits Human Heme Metabolism 2. Moreover, black seed exerts an antiviral effect on the replication of old coronavirus and the expression of (TRP-genes) family 3. In addition, Omega-3 regulates the human immunity against bacterial and viral infections 4. During the past years, many natural sources exerts an antimalarial effect with perfect reported results 5. | ||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Actual Enrollment ICMJE |
150 | ||||||||||||
Original Estimated Enrollment ICMJE |
200 | ||||||||||||
Actual Study Completion Date ICMJE | December 4, 2021 | ||||||||||||
Actual Primary Completion Date | November 4, 2020 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 25 Years to 40 Years (Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | Saudi Arabia | ||||||||||||
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Administrative Information | |||||||||||||
NCT Number ICMJE | NCT04553705 | ||||||||||||
Other Study ID Numbers ICMJE | TQ/Omega-3 on COVID-19 DOI: 10.31219/osf.io/u56fc ( Other Identifier: OSFPREPRINTS- MAY-4/2020 ) |
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Has Data Monitoring Committee | Not Provided | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||||||
Current Responsible Party | Mohamed Medhat Abdelwahab Gamaleldin, Beni-Suef University | ||||||||||||
Original Responsible Party | Mohamed Medhat Abdelwahab Gamaleldin, Beni-Suef University, Ph.D candidate Mohamed Medhat Abdelwahab Gamaleldin | ||||||||||||
Current Study Sponsor ICMJE | Beni-Suef University | ||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Beni-Suef University | ||||||||||||
Verification Date | July 2022 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |