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黑种草治疗 COVID-19:一项开放标签随机对照临床试验。

Nigella sativa for the treatment of COVID-19: An open-label randomized controlled clinical trial.

机构信息

Department of Natural Products and Alternative Medicine, Faculty of Pharmacy, King Abdulaziz University 80260, Jeddah, 21589, Saudi Arabia.

Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.

出版信息

Complement Ther Med. 2021 Sep;61:102769. doi: 10.1016/j.ctim.2021.102769. Epub 2021 Aug 15.

Abstract

BACKGROUND

Effective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral and immunomodulatory activities, and has been recommended for the treatment of COVID-19. This study aimed to evaluate the efficacy of NSO treatment in patients with COVID-19.

METHODS

All adult patients with mild COVID-19 symptoms presented to King Abdulaziz University Hospital, Jeddah, Saudi Arabia, were recruited for an open label randomized clinical trial (RCT). They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. Symptoms were daily monitored via telecommunication. The primary outcome focused on the percentage of patients who recovered (symptom-free for 3 days) within 14-days. The trial was registered at clinicaltrials.gov (NCT04401202).

RESULTS

A total of 173 patients were enrolled for RCT. The average age was 36(±11) years, and 53 % of patients were males. The control and NSO groups included 87 and 86 patients respectively. The percentage of recovered patients in NSO group (54[62 %]) was significantly higher than that in the control group (31[36 %]; p = 0.001). The mean duration to recovery was also shorter for patients receiving NSO (10.7 ± 3.2 days) compared with the control group (12.3 ± 2.8 days); p = 0.001.

CONCLUSIONS

NSO supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies.

摘要

背景

针对 2019 年冠状病毒病(COVID-19)的有效治疗方法正在深入研究中。黑种草籽油(NSO)是一种具有抗病毒和免疫调节作用的草药,已被推荐用于 COVID-19 的治疗。本研究旨在评估 NSO 治疗 COVID-19 患者的疗效。

方法

所有在沙特阿拉伯吉达阿卜杜勒阿齐兹国王大学医院就诊的轻度 COVID-19 症状的成年患者均被招募参加一项开放标签随机临床试验(RCT)。他们被随机分为对照组或治疗组,后者每天接受 500mg NSO(MARNYS® Cuminmar)两次,持续 10 天。通过远程通讯每天监测症状。主要结局是关注在 14 天内恢复(无症状 3 天)的患者比例。该试验在 clinicaltrials.gov(NCT04401202)注册。

结果

共有 173 名患者参加了 RCT。平均年龄为 36(±11)岁,53%的患者为男性。对照组和 NSO 组分别包括 87 名和 86 名患者。NSO 组(54[62%])的恢复患者比例明显高于对照组(31[36%];p=0.001)。接受 NSO 治疗的患者恢复的平均时间也较短(10.7±3.2 天),而对照组为(12.3±2.8 天);p=0.001。

结论

与单独接受常规护理相比,NSO 补充剂可使轻度 COVID-19 感染患者的症状更快恢复。这些潜在的治疗益处需要进一步通过安慰剂对照、双盲研究来探索。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8ab8/8364675/31a39e029a72/gr1_lrg.jpg

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