UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of chicken extract on breast milk production of primiparous mothers in Japan: A randomized experimental study
Title of the study (Brief title)	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	Masayo Awano
Organization	Kanazawa University
Division name	Department of Health Development Nursing, Kanazawa University Graduate School of Medical Science
Address	5-11-80 Kodatsuno, Kanazawa, Ishikawa 920-0942, Japan
TEL	076-265-2500
Email	masayo@po2.nsknet.or.jp

Public contact
Name of contact person	Masayo Awano
Organization	Kanazawa University
Division name	Department of Health Development Nursing, Kanazawa University Graduate School of Medical Science
Address	81-1-401 Urokomachi Kanazawa Ishikawa
TEL	076-224-4192
Homepage URL
Email	masayo@po2.nsknet.or.jp

Sponsor
Institute	NPO Science Research Center Alternative Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031125