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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031230190

Enrollment

Registered

2023-06-28

Start date

2023-06-28

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Those who are scheduled to receive the new corona vaccine new corona vaccination

Interventions

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

Oral administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.)

Design outcomes

Primary

Measure	Time frame
Presence or absence of fever in the morning (7:00 am to 12:00) the day after vaccination	—

Secondary

Measure	Time frame
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	—

Countries

Japan, nate

Contacts

Public ContactTakao Namiki

Medical Mycology Research Center, Chiba University

tnamiki@faculty.chiba-u.jp+81-432262984

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026