Clinical trial NCT05387252: Glucoside- and Rutinoside-rich Crude Material for Relieving Side Effects of COVID-19 Vaccines
Official title: Dose-response Study a Glucoside- and Rutinoside-rich Crude Material in Relieving Side Effects of COVID-19 Vaccines
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaccine Adverse Reaction
Side-Effect
Keywords: COVID-19
Vaccine Adverse Reaction
Side Effect
Inflammation
Pain
Mulberry
IL-17
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 93
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are divided into three groups, namely, the low dose group (10 ml), middle dose group (50 ml), and high dose group (100 ml).
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unable to read the google sheets
* dysphagia
* \> 65 years

Primary outcomes:
measure: Change of body temperature
timeFrame: Up to four days
measure: Number of participants with fever
timeFrame: Up to four days
Secondary outcomes:
measure: Number of participants with sign cluster 1 (multiple choices)
timeFrame: Up to three days
measure: Number of participants with sign cluster 2 (multiple choices)
timeFrame: Up to three days
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: El-Wui Loh, PhD
role: PRINCIPAL_INVESTIGATOR
References: