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临床试验/NCT05387252
NCT05387252Unknown不适用

Dose-response Study a Glucoside- and Rutinoside-rich Crude Material in Relieving Side Effects of COVID-19 Vaccines

Taipei Medical University0 个研究点目标入组 93 人开始时间: 2022年5月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
93
主要终点
Change of body temperature

研究概览

简要总结

Urgent vaccine development plus the characteristics of the coronavirus have caused the relatively more safety problems in COVID-19 vaccines than other classic vaccines and unavoidably raises more concerns among those who accept or consider to be vaccinated. Mulberry juice consists of a large amount of anthocyanin. The abnormally high interleukin-17A level is frequently seen in patients with inflammation status or diseases with inflammation features. Some specific anthocyanins can reduce cyclooxygenase and nitrogen oxide, and the pharmacological effect of the major anthocyanin in mulberry juice imitates that of interleukin-17A antagonists. These features make mulberry juice a potential crude material for reducing inflammation and pain induced by COVID-19 vaccinations. The investigators propose a randomized control trial to explore the dose-response effects of three different volumes of mulberry juice on the incidence and severity of COVID-19 induced side effects. The findings should be helpful for nutrition supplementation in COVID-19 vaccinations and may improve public coordination of COVID-19 vaccinations.

详细描述

Since the outbreak of Coronavirus Disease-2019 (COVID-19), the size of the infected population continues to expand, and the number of deaths due to the infection continues to climb. Massive vaccination has become the most critical measure to control the pandemic. Vaccination may cause side effects. Urgent vaccine development plus the characteristics of the coronavirus have caused the relatively more safety problems in COVID-19 vaccines than other classic vaccines and unavoidably raises more concerns among those who accept or consider to be vaccinated. Mulberry juice consists of a large amount of anthocyanin. The abnormally high interleukin-17A level is frequently seen in patients with inflammation status or diseases with inflammation features. Previous cell and animal studies have shown that some specific anthocyanins can reduce cyclooxygenase and nitrogen oxide, and the pharmacological effect of the major anthocyanin in mulberry juice imitates that of interleukin-17A antagonists. These features make mulberry juice a potential crude material for reducing inflammation and pain induced by COVID-19 vaccinations. The investigators propose a randomized control trial investigating the dose-response effects of three different volumes of mulberry juice on the incidence and severity of COVID-19 induced side effects and build up initial dose-response models for future reference in nutrition supplementation in COVID-19 vaccinations and improve public coordination of COVID-19 vaccinations.

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
Double (Participant, Outcomes Assessor)

盲法说明

The participants are told that they would receive a cup of mulberry juice in which the volume is randomized, without knowing the exact dose range.

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mentally capable
  • Can comunicate using Mendalin or Taiwanese dialet
  • Agree to join the current trial

排除标准

  • Unable to read the google sheets
  • dysphagia
  • > 65 years

结局指标

主要结局

Change of body temperature

时间窗: Up to four days

Daily body temperature of each participant is recorded to obtain serial temperatures including body temperature before vaccination (first day) and body temperatures after vaccination (second, third, and fourth day).

Number of participants with fever

时间窗: Up to four days

Event of 38 degrees celsius or above

次要结局

  • Number of participants with sign cluster 1 (multiple choices)(Up to three days)
  • Number of participants with sign cluster 2 (multiple choices)(Up to three days)

研究者

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

El-Wui Loh

Associate Professor

Taipei Medical University

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