UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027159 |
|---|---|
| Receipt number | R000031125 |
| Scientific Title | Effect of chicken extract on breast milk production of primiparous mothers in Japan: A randomized experimental study |
| Date of disclosure of the study information | 2017/04/28 |
| Last modified on | 2018/01/07 12:33:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of chicken extract on breast milk production of primiparous mothers in Japan: A randomized experimental study
Acronym
Effect of chicken extract on breast milk production
Scientific Title
Effect of chicken extract on breast milk production of primiparous mothers in Japan: A randomized experimental study
Scientific Title:Acronym
Effect of chicken extract on breast milk production
Region
| Japan |
Condition
Condition
primiparous lactating mothers
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of chicken extract on breast milk production
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
milk production amount of postpartum 2 days and 4 days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Food |
Interventions/Control_1
Chicken extract
Since 36 gestation of pregnancy, take 70 ml of Brand of Chicken Essence, twice a day, more than two weeks
Interventions/Control_2
Water
Since 36 gestation of pregnancy, take 70 ml of water, twice a day, more than two weeks
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
| 20 | years-old | <= |
Age-upper limit
| 36 | years-old | > |
Gender
Female
Key inclusion criteria
Primiparous women who wanted to breastfeed, were healthy, and whose pregnancies proceeded normally.
Key exclusion criteria
A) Exclusion criteria before commencement of test
1) participants have chicken allergy, 2) participants have morphological abnormalities of nipple, 3) participants have scheduled for caesarean section, 4) participants have hypertension, 5)participants have
diabetes, 6) participants have mental illness,
7) anemia (person with Hb of less than 9.0 mg / dl), 8) medicating medicine, 9) judged by physicians to be inappropriate for participation
B) Cancellation criteria after commencement of test
1) person who has become childbirth before 38 weeks gestation, 2) cases where they wish to stop the examination, 3) special mother's or child's abnormality is recognized after starting the exam, 4) cesarean section during the examination who underwent surgery such as surgery, 5) participants who diagnosed by doctors that unsuitable for continued testing
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayo Awano |
Organization
Kanazawa University
Division name
Department of Health Development Nursing, Kanazawa University Graduate School of Medical Science
Zip code
Address
5-11-80 Kodatsuno, Kanazawa, Ishikawa 920-0942, Japan
TEL
076-265-2500
masayo@po2.nsknet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayo Awano |
Organization
Kanazawa University
Division name
Department of Health Development Nursing, Kanazawa University Graduate School of Medical Science
Zip code
Address
81-1-401 Urokomachi Kanazawa Ishikawa
TEL
076-224-4192
Homepage URL
masayo@po2.nsknet.or.jp
Sponsor or person
Institute
NPO Science Research Center Alternative Medicine
Institute
Department
Personal name
Funding Source
Organization
NPO Science Research Center Alternative Medicine
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 28 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | 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
| 2017 | Year | 04 | Month | 27 | Day |
Last modified on
| 2018 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031125
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
