Vaccine Adverse ReactionNCT05387252
Glucoside- and Rutinoside-rich Crude Material for Relieving Side Effects of COVID-19 Vaccines
A study testing Mulberry juice in people with Vaccine Adverse Reaction and Side-Effect, run by Taipei Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Adverse Reaction, Side-Effect
- What is being tested?
- Mulberry juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Concious
- Mentally capable
- Can comunicate using Mendalin or Taiwanese dialet
- Agree to join the current trial
Who cannot join
- Unable to read the google sheets
- dysphagia
- > 65 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Dose-response Study a Glucoside- and Rutinoside-rich Crude Material in Relieving Side Effects of COVID-19 Vaccines
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.
Read the 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.
- Conditions
- Vaccine Adverse Reaction, Side-Effect
- Being tested
- Mulberry juice
- Keywords
- COVID-19, Vaccine Adverse Reaction, Side Effect, Inflammation, Pain, Mulberry, IL-17
- Medical subject headings
- COVID-19, Inflammation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulberry juiceDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Low volume mulberry juice | Experimental | 10 ml mulberry juice containing about 48 mg polyphenols Receives: Dietary Supplement: Mulberry juice |
| Middle volume mulberry juice | Experimental | 50 ml mulberry juice containing about 240 mg polyphenols Receives: Dietary Supplement: Mulberry juice |
| High volume mulberry juice | Experimental | 100 ml mulberry juice containing about 480 mg polyphenols Receives: Dietary Supplement: Mulberry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to four days
Number of participants with fever
Event of 38 degrees celsius or above
Measured: Up to four days
Secondary outcomes (2)
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
Measured: Up to three days
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
Measured: Up to three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start31 May 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Wui Loh, Taipei Medical University
- Investigators
- El-Wui Loh, PhD, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387252
- Sponsor's protocol ID
- N202202030
- Status last verified
- May 2022
- First submitted
- 19 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Study a Glucoside- and Rutinoside-rich Crude Material in Relieving Side Effects of COVID-19 Vaccines
- ClinicalTrials.gov ID
- NCT05387252
- Acronym / sponsor ID
- N202202030
- Conditions
- Vaccine Adverse Reaction, Side-Effect
- Keywords
- COVID-19, Vaccine Adverse Reaction, Side Effect, Inflammation, Pain, Mulberry, IL-17
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 31 May 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Low volume mulberry juice | Experimental | Dietary Supplement: Mulberry juice10 ml mulberry juice containing about 48 mg polyphenols |
| Middle volume mulberry juice | Experimental | Dietary Supplement: Mulberry juice50 ml mulberry juice containing about 240 mg polyphenols |
| High volume mulberry juice | Experimental | Dietary Supplement: Mulberry juice100 ml mulberry juice containing about 480 mg polyphenols |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Concious
- Mentally capable
- Can comunicate using Mendalin or Taiwanese dialet
- Agree to join the current trial
Key exclusion criteria (3 listed)
- Unable to read the google sheets
- dysphagia
- > 65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulberry juiceMulberry 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. | Dietary supplement | High volume mulberry juice, Low volume mulberry juice, Middle volume mulberry juice |
Primary outcome
Change of body temperature
Time frame: 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
Time frame: Up to four days
Event of 38 degrees celsius or above
2 secondary outcomes
Number of participants with sign cluster 1 (multiple choices)
Time frame: Up to three days
Number of participants with sign cluster 2 (multiple choices)
Time frame: Up to three days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
El-Wui Loh, PhD principal investigator
Taipei Medical University Shuang Ho Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Mulberry juice in people with Vaccine Adverse Reaction and Side-Effect, run by Taipei Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact El-Wui Loh, PhD (0903136037, lohew@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of body temperature (time frame: Up to four days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.