The Role of Honey and Nigella Sativa in the Management of COVID-19; A Randomized Controlled, Open-label, Add-on Trial in Pakistan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 2
- 主要终点
- Days required to get a positive COVID-19 PCR to negative
研究概览
简要总结
To evaluate the effectiveness of Nigella Sativa and honey stirred in 250 ml of distilled water 12 hourly till patient becomes asymptomatic or a maximum of 14 days with standard hospital care versus standard hospital care alone with placebo capsule and 250 ml water, in clearing the COVID-19 nucleic acid from throat and nasal swab, lowering disease detrimental effects on HRCT chest/X-ray and severity of symptoms along with duration of hospital stay till day 14th day of follow up and 30 days mortality (primary outcomes).
详细描述
This cohort, adaptive, randomized, double armed group, controlled, Investigator Initiated interventional study is designed to demonstrate the superiority of a combination of black cumin with honey over standard care in SARS-CoV-2 (COVID-19) infected patients who consent to randomization following a new diagnosis in Pakistan with an SSC-2 score of > 5 with positive RT-PCR of COVID-19.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result with SSC-2 score> 5
- •Patients admitted in Corona centers
排除标准
- •Participants not giving consent.
- •Pregnant and lactating females.
- •History of allergy to any drug being administered in this study
- •Severely terminally ill patients
- •Patients on Nil Per Oral
研究组 & 干预措施
Nigella Sativa & Honey Group
Drug: Nigella Sativa seed Powder 80 mg/Kg/day grinded in capsule upto a max of 14 days) Drug: Natural Honey 1gm/kg/day orally upto a max of 14 days)
along with standard medical care
干预措施: Honey (Drug)
Nigella Sativa & Honey Group
Drug: Nigella Sativa seed Powder 80 mg/Kg/day grinded in capsule upto a max of 14 days) Drug: Natural Honey 1gm/kg/day orally upto a max of 14 days)
along with standard medical care
干预措施: Nigella Sativa / Black Cumin (Drug)
Standard Medical Care
Standard supportive medical care prescribed by treating physician, Lahore which includes standard symptomatic care along with use of antibacterial or antiviral (if advised by pulmonologist or infectious disease specialist)
干预措施: Placebos (Drug)
结局指标
主要结局
Days required to get a positive COVID-19 PCR to negative
时间窗: upto max 14 days
Severity of symptoms progression
时间窗: upto max 14 days
Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe.
Duration of Hospital Saty
时间窗: upto max 14 day
Duration of hospital stay would be categorized as the number of days the patient stayed in the ward during treatment. The date of admission and date of discharge would give us total duration of stay.
30 day mortality
时间窗: 30 days
30 days mortality rate in each arm
Clinical Grade Status
时间窗: 0, 4, 6, 8, 10 and 12 day
grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death).
Fever
时间窗: 13 days
Degree of fever
次要结局
- Oxygen Saturation at room air(upto max of 14 days)
研究者
Sohaib Ashraf
Post-Graduate Resident Cardiology
Sheikh Zayed Federal Postgraduate Medical Institute