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| Name | Class |
|---|---|
| University of Khartoum | OTHER |
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To study the efficacy of Gum Arabic as an immuno modulator and anti-inflammatory agent among COVID 19 seropositive patients..Half of participants will receive Gum Arabic and the other half will receive placebo
Randomized placebo controlled trial including COVID 19 seropositive patients will be treated with 30 gram per day for 4 weeks, compared to placebo group treated for the same duration in positive COVID 19 patients.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose |
|
| Control group | Placebo Comparator | This group will be provided with pectin powder provided as one-gram-dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acacia Senegal | Dietary Supplement | Oral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline score of Immune Response to end of the trial ( Time Frame: up to 4 weeks ) | Changes of the level of Tumor Necrosis Factor (TNF), interleukin IL8,IL6,IL10 from the baseline values | 4 weeks |
| Mortality rate | The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo | from the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to two months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine viral load in each patient | Change of viral load from Baseline | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| clinical improvement and hospital discharge | Time of discharge from hospital after full recovery | from the date of assignment until the date of hospital discharge for the last assigned case, whichever comes first, assessed up to two months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Babiker, PhD | Contact | +249912951517 | rashat33@yahoo.com | |
| Shahenaz Satti, MSc | Contact | +249912204825 | shahenazsatti@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mustafa KM Nimeiri, MD | Al Neelain University, Faculty of Medicine | Study Chair |
| Moawia M Mukhtar, PhD | University of Khartom , Institute of Endemic Diseases | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omdurman Teaching Hospital | Khartoum | Omdurman | Sudan | |||
| Jabra Hospital, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32328307 | Background | 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. | |
| 30112005 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006170 | Gum Arabic |
| D010368 | Pectins |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Pectin | Dietary Supplement | Oral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks |
|
| Khartoum |
| Sudan |
| 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. |
| 32287140 | Background | 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. |
| 32376400 | Background | 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. |
| 32891160 | Derived | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |