UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study of the effects of Ninjin'yoeito on anemia and depressive symptoms in postpartum women
Acronym	Effects of Ninjin'yoeito on anemia and depressive symptoms in postpartum women
Scientific Title	A prospective study of the effects of Ninjin'yoeito on anemia and depressive symptoms in postpartum women
Scientific Title:Acronym	Effects of Ninjin'yoeito on anemia and depressive symptoms in postpartum women
Region	Japan

Condition
Condition	Postpartum anemia
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of Ninjin'yoeito on anemia and depressive symptoms in postpartum women
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of hemoglobin levels, Prevalence of depressive symptoms as determined by the Edinburgh Postnatal Depression Scale(EPDS)
Key secondary outcomes	Change of fatigue(NRS)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Kracie Ninjin'yoeito, 7.5g per day, 4weeks
Interventions/Control_2	Ferrous fumarate, 1cap per day, 4weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	(1)Patients with anemia(hemoglobin level<11g/dl)at 1 to 2 days postpartum. (2)Patients who have provided consent for participation.
Key exclusion criteria	(1) Patients having past history of aldosteronism, myopathy, liver dysfunction, or jaundice. (2)Patients whom investigators consider to be ineligible.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Sho-ichi Middle name Last name Kawakami
Organization	Fukuda Hospital
Division name	Department of Obstetrics and Gynecology
Zip code	8600004
Address	2-2-6 Shinmachi , Kumamoto Chuo - ku , Kumamoto
TEL	096-322-2995
Email	kawakami@fukuda-hp.or.jp

Public contact
Name of contact person	1st name Sho-ichi Middle name Last name Kawakami
Organization	Fukuda Hospital
Division name	Department of Obstetrics and Gynecology
Zip code	8600004
Address	2-2-6 Shinmachi , Kumamoto Chuo - ku , Kumamoto
TEL	096-322-2995
Homepage URL
Email	kawakami@fukuda-hp.or.jp

Sponsor
Institute	Fukuda Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Fukuda Hospital
Address	2-2-6 Shinmachi , Kumamoto Chuo - ku , Kumamoto
Tel	096-322-2995
Email	m-kai@fukuda-hp.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	福田病院（熊本県）

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2019 Year 08 Month 29 Day
Date of IRB	2019 Year 09 Month 05 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 06 Day
Last modified on	2022 Year 05 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050376