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临床试验/NCT05360004
NCT05360004Unknown2 期

The Use of Chinese Herbal Medicine and Vitamin C by Hospital Care Workers in Hong Kong Mobile Cabin Hospital to Prevent COVID-19 Transmission: A Prospective, Randomized Controlled Trial

Hong Kong Baptist University0 个研究点目标入组 652 人开始时间: 2022年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
652
主要终点
Proportion of subjects who become SARS-CoV-2 positive

研究概览

简要总结

This is a prospective randomized controlled trial study to explore whether the combination of Chinese herbal medicine and Vitamin C is effective and safe to prevent COVID-19 transmission among health care workers in Hong Kong Mobile Cabin Hospital governed by the Hong Kong Hospital Authority who have been caring for patients with COVID-19. A total of 652 adults will be enrolled. Eligible subjects who provide written informed consent will be assessed for inclusion/exclusion criteria.

All participants are asymptomatic and test negative for SARS-CoV-2 at the study's commencement. Subjects with major medical illness, renal insufficiency and hypersensitivity to Chinese herbal medicine will be excluded. All participants will receive Vitamin C (VC) supplementation and 28 packets of the herbal medicine free of charge and are advised to consume daily for 14 days. After written informed consent, the subjects will be included and randomly allocated to either CHM+VC group or VC treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Health care workers in Hong Kong Mobile Cabin Hospital;
  • Asymptomatic and test negative for SARS-CoV-2;
  • Voluntarily signing a written informed consent form;

排除标准

  • With major medical illness or renal insufficiency;
  • With hypersensitivity to Chinese herbal medicine;
  • Pregnancy or lactation.

研究组 & 干预措施

CHM+Vc

Experimental

Participants in CHM+VC group are required to consume vitamin C 1000mg/day and 1 sachet (9 g) of granules daily (1 hour after meal by dissolving 1 sachet of 9g granules in 150 ml of hot water and drink it orally) .

干预措施: Chinese herbal medicine (Drug)

Vc

Placebo Comparator

Participants will receive vitamin C 1000mg/day for 14 days

干预措施: Chinese herbal medicine (Drug)

结局指标

主要结局

Proportion of subjects who become SARS-CoV-2 positive

时间窗: 4 weeks

次要结局

  • Number of days of confirmed SARS-CoV-2 infection(4 weeks)
  • Duration of COVID-19-related symptoms in confirmed SARS-CoV-2 infection cases(4 weeks)
  • Safety endpoint(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ZhaoXiang Bian

Professor

Hong Kong Baptist University

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