臨床研究等提出・公開システム

An exploratory, single-arm, externally controlled comparative study to evaluate the efficacy and safety of adverse reaction of vaccine prophylaxis for combining maoto and eppikajutsuto in subjects planning to receive the new COVID-19 vaccine

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

Namiki Takao

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba Prefecture

tnamiki@faculty.chiba-u.jp

Namiki Takao

Medical Mycology Research Center, Chiba University

1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba Prefecture

+81-432262984

tnamiki@faculty.chiba-u.jp

Recruiting

June. 28, 2023

Interventional

single arm study

open(masking not used)

active control

single assignment

treatment purpose

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

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.)

Both

Those who are scheduled to receive the new corona vaccine

In the study drug treatment group, 3 maoto extract tablets and 6 eppikajutsuto extract tablets will be administered twice.

new corona vaccination

Oral administration

Presence or absence of fever <37.5 degrees or higher> in the morning (7:00 am to 12:00) the day after vaccination

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

+81-432262616

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