UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015151 |
|---|---|
| Receipt number | 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 10:41:43 |
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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
| Obstetrics 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
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
c-hkakutou@eph.pref.ehime.jp
Sponsor or person
Institute
Ehime Prefectural Central 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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017624
| Research Plan | |
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| 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 |
