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

NCT ID: NCT04381871

Last Updated: 2020-05-12

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-09-01

Brief Summary

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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

Detailed Description

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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

Conditions

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COVID 19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Group Type EXPERIMENTAL

Acacia Senegal

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Pectin

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Pectin

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Gum Arabic

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Intubated patients on parental treatment
Minimum Eligible Age

5 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Khartoum

OTHER

Sponsor Role collaborator

Al-Neelain University

OTHER

Sponsor Role lead

Responsible Party

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Lamis Kaddam

Dr.Lamis Kaddam

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Jabra Hospital,

Khartoum, , Sudan

Site Status

Countries

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Sudan

Central Contacts

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Dr Babiker, PhD

Role: CONTACT

+249912951517

Shahenaz Satti, MSc

Role: CONTACT

+249912204825

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.

Reference Type BACKGROUND
PMID: 32328307 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30112005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32287140 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32376400 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32891160 (View on PubMed)

Other Identifiers

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GA& COVID19

Identifier Type: -

Identifier Source: org_study_id

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