Effect of Kampo medicine on those who plan to receive the new COVID-19 vaccine

JRCT ID: jRCTs031230190

Registered date:28/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Those who are scheduled to receive the new corona vaccine
• Date of first enrollment: 28/06/2023
• Target sample size: 40
• Countries of recruitment: nate,Japan
• Study type: Interventional
• Intervention(s): In the study drug treatment group, 3 maoto extract tablets and 6 eppikajutsuto extract tablets will be administered twice.

Outcome(s)

• Primary Outcome: Presence or absence of fever <37.5 degrees or higher> in the morning (7:00 am to 12:00) the day after vaccination
• Secondary Outcome: Presence or absence of malaise, headache, arthralgia, and pain at the injection site, which are considered to be side effects of the vaccine, and the duration of each symptom, Presence or absence of adverse events after oral administration of Kampo medicine, frequency of occurrence of each symptom

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 40age old
• Gender: Both

Include criteria

1.Adults aged between 18 and 40 at the time of obtaining consent
2.Those who are eligible for the new corona vaccine and can be vaccinated

Exclude criteria

1.Those who are taking other Kampo medicines on the day of vaccination
2.Those who have a history of adverse events such as allergies to Kampo medicines in the past
3.Those who are pregnant, may be pregnant, have given birth within 28 days, or are breastfeeding
4.Those who have been diagnosed with arrhythmia, coronary artery disease, heart disease such as heart failure, renal failure, thyroid dysfunction, or prostatic hyperplasia
5.Those with symptoms of swelling, dysuria, and palpitations
6.Those who have uncontrolled hypertension (systolic blood pressure of 150 mmHg or more or diastolic blood pressure of 90 mmHg or more)
7.Extremely thin (BMI less than 18.5)
8.KPS 70 or less (KPS 70 = able to take care of themselves but unable to perform normal activities/work)
9.Others judged by the principal investigator or co-investigator to be inappropriate for the safe conduct of this study (physical weakness, etc.)

Related Information

• Primary Sponsor: Namiki Takao
• Source(s) of Monetary Support: Clinical Research Initiation-Fund (of Chiba University Hospital)