ClinicalTrials.gg
Status unknownNCT04381871GA&COVID19Updated May 12, 2020

Potential Role of Gum Arabic as Immunomodulatory Agent Among COVID 19 Patients

A Phase 2/3 interventional study of Acacia Senegal and Pectin in COVID 19, sponsored by Al-Neelain University. Status unknown at 2 sites in Sudan. Open to participants aged 5 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-05-12.

Sponsored by Al-Neelain University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
5 Years to 90 Years
Sex
All
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Study 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

Read the detailed 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

02

Conditions studied

  • COVID 19

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Keywords

  • Gum Arabic
  • Immunomodulator
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 110 is close to the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Al-Neelain University is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Intubated patients on parental treatment
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose

    Dietary Supplement: Acacia Senegal

  • Placebo comparator
    Control group

    This group will be provided with pectin powder provided as one-gram-dose

    Dietary Supplement: Pectin

Interventions

  • Dietary supplementAcacia Senegal

    Oral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks

    Also known as: Gum Arabic

  • Dietary supplementPectin

    Oral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 weeks

  2. Mortality rate

    The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo

    Time frame: 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 outcomes

  1. Determine viral load in each patient

    Change of viral load from Baseline

    Time frame: 4 weeks

Other outcomes

  1. clinical improvement and hospital discharge

    Time of discharge from hospital after full recovery

    Time frame: from the date of assignment until the date of hospital discharge for the last assigned case, whichever comes first, assessed up to two months

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Study locations

2 sites
  • Omdurman Teaching Hospital
    Khartoum, Omdurman, Sudan
  • Jabra Hospital,
    Khartoum, Sudan
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References and documents

Publications

  • 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. PubMed 32328307 ↗
  • 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. PubMed 30112005 ↗
  • 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. PubMed 32287140 ↗
  • 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. PubMed 32376400 ↗
  • 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. PubMed 32891160 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2020; primary completion for Aug 2020, 2 months later.

Of 95 non-industry phase 2/3 interventional studies under COVID-19, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 22. This study's planned 2 months is below that.

Counting every sponsor, half of 168 studies reached it within 11 months; a quarter within 5 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2020
First posted
May 11, 2020
StartEst.
Jun 1, 2020
Primary completionEst.
Aug 1, 2020
CompletionEst.
Sep 1, 2020
Last update
May 12, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04381871
Lead sponsor
Al-Neelain University
Collaborators
University of Khartoum
Responsible party
Lamis Kaddam (Dr.Lamis Kaddam, Al-Neelain University) — Principal investigator
First posted
May 11, 2020
Start date
Jun 1, 2020 (estimated)
Primary completion
Aug 1, 2020 (estimated)
Completion
Sep 1, 2020 (estimated)
Last update
May 12, 2020

Study contacts

Dr Babiker, PhD
Contact
rashat33@yahoo.com
+249912951517
Shahenaz Satti, MSc
Contact
shahenazsatti@gmail.com
+249912204825
Mustafa KM Nimeiri, MD
study chair · Al Neelain University, Faculty of Medicine
Moawia M Mukhtar, PhD
study director · University of Khartom , Institute of Endemic Diseases

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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