Phase II ,III Randomized Double Blind Parallel Arms Clinical Trial of Potential Role of Gum Arabic ( Acacia Senegal) as Immunomodulatory Agent Among COVID 19 Patients in Sudan
试验速览
- 阶段
- 2 期
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Mean change from baseline score of Immune Response to end of the trial ( Time Frame: up to 4 weeks )
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID 19 infected as proved by real time PCR (polymerase chain reaction) .( newly diagnosed)
排除标准
- •Intubated patients on parental treatment
结局指标
主要结局
Mean change from baseline score of Immune Response to end of the trial ( Time Frame: up to 4 weeks )
时间窗: 4 weeks
Changes of the level of Tumor Necrosis Factor (TNF), interleukin IL8,IL6,IL10 from the baseline values
Mortality rate
时间窗: 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
次要结局
- Determine viral load in each patient(4 weeks)
研究者
Lamis Kaddam
Dr.Lamis Kaddam
Al-Neelain University