Potential Role of Gum Arabic as Immunomodulatory Agent Among COVID 19 Patients
NCT ID: NCT04381871
Last Updated: 2020-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
110 participants
INTERVENTIONAL
2020-06-01
2020-09-01
Brief Summary
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Detailed Description
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Blood samples will be taken first at base line level, after two weeks and after the intervention after satisfying the inclusion and exclusion criteria. The main objective is to assess the effect of Gum Arabic (acacia Senegal) on immune system among COVID-19 patients. The outcome of this project understand SARS-CoV-2 immune response in COVID patients and the effect of Gum Arabic (Acacia Senegal) consumption to counteract progression of the disease
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention Group
This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose
Acacia Senegal
Oral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks
Control group
This group will be provided with pectin powder provided as one-gram-dose
Pectin
Oral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks
Interventions
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Acacia Senegal
Oral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks
Pectin
Oral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
5 Years
90 Years
ALL
No
Sponsors
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University of Khartoum
OTHER
Al-Neelain University
OTHER
Responsible Party
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Lamis Kaddam
Dr.Lamis Kaddam
Principal Investigators
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Mustafa KM Nimeiri, MD
Role: STUDY_CHAIR
Al Neelain University, Faculty of Medicine
Moawia M Mukhtar, PhD
Role: STUDY_DIRECTOR
University of Khartom , Institute of Endemic Diseases
Locations
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Omdurman Teaching Hospital
Khartoum, Omdurman, Sudan
Jabra Hospital,
Khartoum, , Sudan
Countries
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Central Contacts
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References
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Ali NE, Kaddam LA, Alkarib SY, Kaballo BG, Khalid SA, Higawee A, AbdElhabib A, AlaaAldeen A, Phillips AO, Saeed AM. Gum Arabic (Acacia Senegal) Augmented Total Antioxidant Capacity and Reduced C-Reactive Protein among Haemodialysis Patients in Phase II Trial. Int J Nephrol. 2020 Apr 9;2020:7214673. doi: 10.1155/2020/7214673. eCollection 2020.
Kamal E, Kaddam LA, Dahawi M, Osman M, Salih MA, Alagib A, Saeed A. Gum Arabic Fibers Decreased Inflammatory Markers and Disease Severity Score among Rheumatoid Arthritis Patients, Phase II Trial. Int J Rheumatol. 2018 Jul 5;2018:4197537. doi: 10.1155/2018/4197537. eCollection 2018.
Pan L, Mu M, Yang P, Sun Y, Wang R, Yan J, Li P, Hu B, Wang J, Hu C, Jin Y, Niu X, Ping R, Du Y, Li T, Xu G, Hu Q, Tu L. Clinical Characteristics of COVID-19 Patients With Digestive Symptoms in Hubei, China: A Descriptive, Cross-Sectional, Multicenter Study. Am J Gastroenterol. 2020 May;115(5):766-773. doi: 10.14309/ajg.0000000000000620.
Ruscitti P, Berardicurti O, Iagnocco A, Giacomelli R. Cytokine storm syndrome in severe COVID-19. Autoimmun Rev. 2020 Jul;19(7):102562. doi: 10.1016/j.autrev.2020.102562. Epub 2020 May 3. No abstract available.
Kaddam L, Babiker R, Ali S, Satti S, Ali N, Elamin M, Mukhtar M, Elnimeiri M, Saeed A. Potential Role of Acacia Senegal (Gum Arabic) as Immunomodulatory Agent among newly diagnosed COVID 19 Patients: A structured summary of a protocol for a randomised, controlled, clinical trial. Trials. 2020 Sep 5;21(1):766. doi: 10.1186/s13063-020-04707-2.
Other Identifiers
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GA& COVID19
Identifier Type: -
Identifier Source: org_study_id
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