Effects of Nigella Sativa as a Treatment of Patients With Upper Respiratory Tract Infection Caused by SARS-coronavirus-2: a Prospective, Randomized, Open-label, Controlled Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Clinical Recovery Within 14 Days After Randomization
研究概览
简要总结
Natural products with immunomodulation and antiviral activity showed a promising improvement in the outcomes of some viral infectious diseases both in preclinical and primitive clinical studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary outcome will be the proportion of patients who clinically recovered on day 14. The secondary outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes occurred, NS supplementation may be recommended as an add-on to standard care protocol to enhance the recovery from COVID-19 disease in the current emerging situation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild COVID19 upper respiratory tract infection and with no evidence of pneumonia
- •Adult (18 Years and above)
- •Written informed consent prior to initiation of any study procedures by the patient (or legally authorized representative).
- •Understands and agrees to comply with planned study procedures.
- •Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) available at KAUH.
排除标准
- •Patients with pneumonia or severe illness requiring admission to ICU.
- •Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) < 30) or end stage renal disease requiring dialysis
- •Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) > 5 times the upper limit of normal).
- •Pregnancy or breast feeding.
- •Anticipated transfer to another hospital which is not a study site within 72 hours.
- •Allergy to any study medication.
结局指标
主要结局
Percentage of Participants With Clinical Recovery Within 14 Days After Randomization
时间窗: Day 14
The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)
次要结局
- Duration of Each Symptom(Day 14)
- Hospital Admission Due to Disease Complications(Day 14)
- Side Effects(Day 14)
- The Number of Days to Recovery(Day 14)
研究者
Dr Abdulrahman E. Koshak
Assistant Professor
King Abdulaziz University