臨床研究等提出・公開システム

Japanese

Date of registration	June. 28, 2023
Last modified on	April. 04, 2024
Trial ID	jRCTs031230190

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

Contact for Scientific Queries	Name	Namiki Takao
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba Prefecture
	Telephone	+81-432262984
	E-mail	tnamiki@faculty.chiba-u.jp
Contact for Public Queries	Name	Namiki Takao
	Affiliation	Medical Mycology Research Center, Chiba University
	Address	1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba Prefecture
	Telephone	+81-432262984
	E-mail	tnamiki@faculty.chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 28, 2023
Actual date of first enrollment
Target sample size		40
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	active control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion 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	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.)
	Age Minimum	18age old over
	Age Maximum	40age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Those who are scheduled to receive the new corona vaccine
Intervention(s)		In the study drug treatment group, 3 maoto extract tablets and 6 eppikajutsuto extract tablets will be administered twice.
Health Condition(s) Keyword		new corona vaccination
Intervention(s) Keyword		Oral administration
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		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(s)		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

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Clinical Research Initiation-Fund (of Chiba University Hospital)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba Prefecture, Chiba, Chiba
Telephone	+81-432262616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	June. 26, 2023

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	nate

History of Changes

No	Publication date
3	April. 04, 2024	(this page)	Changes
2	Mar. 27, 2024	Detail	Changes
1	June. 28, 2023	Detail

List of change history