臨床研究等提出・公開システム

Date of registration	June. 02, 2025
Last modified on	June. 02, 2025
Trial ID	jRCT1051250038

Scientific Title	Investigation of Kamikihito on anxiety in postpartum mental status.
Public Title	Retrospective study of Kamikihito.

Contact for Scientific Queries	Name	Tachibana Daisuke
	Affiliation	Osaka Metropolitan Univeresity Graduate Shoool of Medicine
	Address	1-4-3 Asahimachi, Abeno-ku, Osaka-city
	Telephone	+81-6-6645-3862
	E-mail	dtachibana@omu.ac.jp
Contact for Public Queries	Name	Misugi Takuya
	Affiliation	Osaka Metropolitan Univeresity Graduate Shoool of Medicine
	Address	1-4-3 Asahimachi, Abeno-ku, Osaka-city
	Telephone	+81-6-6645-3862
	E-mail	t-misugi@omu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 05, 2025
Actual date of first enrollment		Mar. 05, 2025
Target sample size		450
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	factorial assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who delivered at the Department of Obstetrics and Gynecology, Osaka Metropolitan University Hospital between March 1, 2022 and December 31, 2027 Patients with EPDS score between 5 and 8 on the third postpartum day or at the 2 week checkup Patients who were judged to have anxiety symptoms by a physician's interview in the Kamikihito exposure group
	Exclusion Criteria	Patients with a history of taking psychotropic drugs within the past year from the date of delivery
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Patients with anxiety in mental during postpartum period
Health Condition(s) Keyword		Anxiety in the puerperium
Health Condition(s) Code		F530
Primary Outcome(s)		Odds of 9 or more EPDS points at 1 month postpartum
Secondary Outcome(s)		1. EPDS positive conversion rate (percentage of patients with an EPDS score of 9 or higher) in patients treated with or without Kamikihito 2. EPDS total score or its change at 1 month postpartum 3. EPDS subscale (depression, anxiety) at 1 month postpartum 4. score of each EPDS item at 1 month postpartum

Primary Sponsor	TSUMURA & CO.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Ethical Committee of Osaka Metropolitan University Graduate School of Medicine
Address	6F, Abeno Medix, 1-2-7 Asahi-machi, Abeno-ku, Osaka City, Osaka
Telephone	+81-6-6645-3456
E-Mail	gr-a-knky-crb@omu.ac.jp
Approval Status	Approval
Date of approval	Mar. 05, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none