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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04381871
Other study ID # GA& COVID19
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 1, 2020
Est. completion date September 1, 2020

Study information

Verified date May 2020
Source Al-Neelain University
Contact Dr Babiker, PhD
Phone +249912951517
Email rashat33@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 110
Est. completion date September 1, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender All
Age group 5 Years to 90 Years
Eligibility Inclusion Criteria:

- COVID 19 infected as proved by real time PCR (polymerase chain reaction) .( newly diagnosed)

Exclusion Criteria:

- Intubated patients on parental treatment

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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

Locations

Country Name City State
Sudan Jabra Hospital, Khartoum
Sudan Omdurman Teaching Hospital Khartoum Omdurman

Sponsors (2)

Lead Sponsor Collaborator
Al-Neelain University University of Khartoum

Country where clinical trial is conducted

Sudan, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Ruscitti P, Berardicurti O, Iagnocco A, Giacomelli R. Cytokine storm syndrome in severe COVID-19. Autoimmun Rev. 2020 May 3:102562. doi: 10.1016/j.autrev.2020.102562. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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
Primary 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
Secondary Determine viral load in each patient Change of viral load from Baseline 4 weeks
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