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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015151
Receipt No. R000017624
Scientific Title Enhancing breast milk secretion with kyukichoketsuin decoction in early puerperal period.
Date of disclosure of the study information 2014/09/14
Last modified on 2014/09/14

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Basic information
Public title Enhancing breast milk secretion with kyukichoketsuin decoction in early puerperal period.
Acronym Enhancing breast milk secretion with kyukichoketsuin decoction in early puerperal period.
Scientific Title Enhancing breast milk secretion with kyukichoketsuin decoction in early puerperal period.
Scientific Title:Acronym Enhancing breast milk secretion with kyukichoketsuin decoction in early puerperal period.
Region
Japan

Condition
Condition mothers who have newborn babys in NICU
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To promote breastfeeding by a study of enhancing breast milk secretion with kyukichoketsuin decoction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes daily amount of breast milk 1)for 3 days before medication, 2)after 7 days of starting medication, 3)after 14 days, 4)when her child leaves NICU.
Key secondary outcomes 1)Nurses evaluate before the intervention and the end of this study about
(1)shape of the breasts and nipples
(2)number of opening breast ducts
2)Participants fill out a questionnaire about following subjective symptoms
(3)stiff shoulders
(4)insomnia
(5)headache
(6)low back pain
(7)depression
(8)sensitivity to cold
(9)fatigue
(10)SF-8

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 kyukichoketsuin decoction
We prepare following daily amount of crude drugs packed in the paper bag, make a decoction for 30 minutes with 600ml of water, condense it to 300ml.
kyukichoketsuin consists of
1)Angelica 2.5g
2)Cnidium 2.5g
3)Rehmannia 2.5g
4)Atractylodes2.5g
5)Poria 2.5g
6)Citrus Peel 2.5g
7)Lindera 2.5g
8)Cyperus 2.5g
9)Moutan 2.5g
10)Licorice 1.0g
11)Jujube 1.0g
12)Steamed Ginger 1.0g
13)Leonurus 1.0g
Interventions/Control_2 control:no therapy
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)Mothers who delivered her babys on from 24 weeks +0 days to 33weeks +6 days, and her babys are hospitalized in the NICU in Ehime Prefectural Central Hospital Perinatal Medical Center
2)They can participate regardless of past childbirth history or method of delivery.
3)Patint provided informed consent in writing.
4)They can read and fill out a questionnaire in Japanese.
5)If the patient is a minor, her protector can sign the letter of consent.
Key exclusion criteria 1)bleeding over 500ml aroud childbirth.
2)infection
3)pregnancy-induced hypertension
4)active mastitis or untreated breast cancer
5)post mastectomy
6)impossible to record amout of breast milk
7)inpossible to stop taking following drugs 3 days before this study
dopamin agonists, dopamin antagonists, estorogen, kampo(oriental herbal medicine)
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kakuto
Organization Ehime Prefectural Central Hospital
Division name Department of East Asian Traditional Medicine
Zip code
Address 83 Kasugamachi Matsuyama Ehime Japan
TEL 089-947-1111
Email c-hkakutou@eph.pref.ehime.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kakuto
Organization Ehime Prefectural Central Hospital
Division name Department of East Asian Traditional Medicine
Zip code
Address 83 Kasugamachi Matsuyama Ehime Japan
TEL 089-947-1111
Homepage URL
Email c-hkakutou@eph.pref.ehime.jp

Sponsor
Institute Ehime Prefectural Central 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
Address
Tel
Email

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 愛媛県立中央病院(愛媛県)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 14 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 Preinitiation
Date of protocol fixation
2014 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 14 Day
Last modified on
2014 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017624

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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