COVID 19
Conditions
Keywords
Gum Arabic, Immunomodulator
Brief 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
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
Interventions
DIETARY_SUPPLEMENTAcacia Senegal
Oral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks
DIETARY_SUPPLEMENTPectin
Oral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks
Sponsors
University of Khartoum
Al-Neelain University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* COVID 19 infected as proved by real time PCR (polymerase chain reaction) .( newly diagnosed)
Exclusion criteria
* Intubated patients on parental treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline score of Immune Response to end of the trial ( Time Frame: up to 4 weeks ) | 4 weeks | Changes of the level of Tumor Necrosis Factor (TNF), interleukin IL8,IL6,IL10 from the baseline values |
| Mortality rate | 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 | The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine viral load in each patient | 4 weeks | Change of viral load from Baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| clinical improvement and hospital discharge | from the date of assignment until the date of hospital discharge for the last assigned case, whichever comes first, assessed up to two months | Time of discharge from hospital after full recovery |
Countries
Sudan
Contacts
Primary ContactDr Babiker, PhD
Backup ContactShahenaz Satti, MSc
Outcome results
None listed