Glucoside- and Rutinoside-rich Crude Material for Relieving Side Effects of COVID-19 Vaccines
Primary Purpose
Vaccine Adverse Reaction, Side-Effect
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mulberry juice
Sponsored by
About this trial
This is an interventional prevention trial for Vaccine Adverse Reaction focused on measuring COVID-19, Vaccine Adverse Reaction, Side Effect, Inflammation, Pain, Mulberry, IL-17
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low volume mulberry juice
Middle volume mulberry juice
High volume mulberry juice
Arm Description
10 ml mulberry juice containing about 48 mg polyphenols
50 ml mulberry juice containing about 240 mg polyphenols
100 ml mulberry juice containing about 480 mg polyphenols
Outcomes
Primary Outcome Measures
Change of body temperature
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
Event of 38 degrees celsius or above
Secondary Outcome Measures
Number of participants with sign cluster 1 (multiple choices)
Redness, swelling, pain, lump or mass, or rash and itching at the injection site; axillary swelling and tenderness at the injection arm; axillary swelling and tenderness at the non-injection arm; none
Number of participants with sign cluster 2 (multiple choices)
Chills, headache, muscle pain, joint pain, fatigue, rash on the body, asthma or breathing difficulty, loss of appetite, nausea or vomiting, diarrhea, stomach ache, insomnia, or drownsiness; none
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05387252
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 31, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccine Adverse Reaction, Side-Effect
Keywords
COVID-19, Vaccine Adverse Reaction, Side Effect, Inflammation, Pain, Mulberry, IL-17
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
93 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low volume mulberry juice
Arm Type
Experimental
Arm Description
10 ml mulberry juice containing about 48 mg polyphenols
Arm Title
Middle volume mulberry juice
Arm Type
Experimental
Arm Description
50 ml mulberry juice containing about 240 mg polyphenols
Arm Title
High volume mulberry juice
Arm Type
Experimental
Arm Description
100 ml mulberry juice containing about 480 mg polyphenols
Intervention Type
Dietary Supplement
Intervention Name(s)
Mulberry juice
Intervention Description
Mulberry is a common macrophanerophyte that can be found in fields or farms. Mulberry fruits contain a large amount of anthocyanins and a relatively small amount of pro-anthocyanins. The plant is easy to grow and the fruit price is low compared with other types of plants producing anthocyanins, and thus a reliable source for anthocyanin supplements. Current laboratory evidence has shown that specific anthocyanins can reduce inflammation status, and potentially thrombosis. One of the enzymes inhibited by specific anthocyanins is cyclooxygenase which catalyzes the synthesis of prostanoids, including thromboxane and prostaglandins. Moreover, a critical study has shown that cyanidin 3-O-glucoside, the main anthocyanin in mulberry fruit, is an allosteric regulator of interleukin-17A.
Primary Outcome Measure Information:
Title
Change of body temperature
Description
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).
Time Frame
Up to four days
Title
Number of participants with fever
Description
Event of 38 degrees celsius or above
Time Frame
Up to four days
Secondary Outcome Measure Information:
Title
Number of participants with sign cluster 1 (multiple choices)
Description
Redness, swelling, pain, lump or mass, or rash and itching at the injection site; axillary swelling and tenderness at the injection arm; axillary swelling and tenderness at the non-injection arm; none
Time Frame
Up to three days
Title
Number of participants with sign cluster 2 (multiple choices)
Description
Chills, headache, muscle pain, joint pain, fatigue, rash on the body, asthma or breathing difficulty, loss of appetite, nausea or vomiting, diarrhea, stomach ache, insomnia, or drownsiness; none
Time Frame
Up to three days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
El-Wui Loh, PhD
Phone
0903136037
Email
lohew@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yun-Yun Chou, Msc
Phone
0974515039
Email
daliner@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
El-Wui Loh, PhD
Organizational Affiliation
Taipei Medical University Shuang Ho Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Glucoside- and Rutinoside-rich Crude Material for Relieving Side Effects of COVID-19 Vaccines
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