UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044116 |
|---|---|
| Receipt number | R000050376 |
| Scientific Title | A prospective study of the effects of Ninjin'yoeito on anemia and depressive symptoms in postpartum women |
| Date of disclosure of the study information | 2021/05/06 |
| Last modified on | 2022/05/10 08:37:06 |
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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
| Obstetrics 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
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
kawakami@fukuda-hp.or.jp
Sponsor or person
Institute
Fukuda Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050376
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
