UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049399 |
|---|---|
| Receipt number | R000056248 |
| Scientific Title | Accupressure and Extract Moringa oleifera on the hormone prolactin and Increased Breast Milk Production |
| Date of disclosure of the study information | 2022/11/25 |
| Last modified on | 2022/11/02 11:00:21 |
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Basic information
Public title
Effect of Combination of Accupressure and Extract Moringa oleifera on the hormone prolactin and Increased Breast Milk Production of Breastfeeding Mothers
Acronym
Increased Breast Milk Production in Breastfeeding Mothers and the Effect of Accupressure and Extract Moringa oleifera on the Hormone Prolactin
Scientific Title
Accupressure and Extract Moringa oleifera on the hormone prolactin and Increased Breast Milk Production
Scientific Title:Acronym
Increased Breast Milk Production and Effects of Acupressure and Extract Moringa oleifera on Prolactin
Region
| Asia(except Japan) |
Condition
Condition
to address breastfeeding mothers' concerns about milk production
Classification by specialty
| Medicine in general | Surgery in general | Rehabilitation medicine |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the community is able to maximize existing natural resources and pass on a culture of accupressure for health
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
acupressure and Moringa leaves can increase milk production
Key secondary outcomes
milk production
prolactin hormone
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
contradictory
Interventions/Control_2
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
| 28 | days-old | <= |
Age-upper limit
| 28 | days-old | >= |
Gender
Female
Key inclusion criteria
breastfeeding mothers with babies aged 0-28 days
Key exclusion criteria
breastfeeding mothers with babies more than 28 days old
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nurul |
| Middle name | |
| Last name | Wahidah |
Organization
Health Polytechnic Ministry of Health Semarang
Division name
research
Zip code
50268
Address
Jl. Tirto Agung, Pedalangan, Kec. Banyumanik, Semarang City, Central Java
TEL
085832589590
wahidahnurul246@gmail.com
Public contact
Name of contact person
| 1st name | Leny |
| Middle name | |
| Last name | latifah |
Organization
Health Polytechnic Ministry of Health Semarang
Division name
research
Zip code
50268
Address
Jl. Tirto Agung, Pedalangan, Kec. Banyumanik, Semarang City, Central Java
TEL
085727180901
Homepage URL
lenylatifah1@gmail.com
Sponsor or person
Institute
Health Polytechnic Ministry of Health Semarang
Institute
Department
Personal name
Funding Source
Organization
Health Polytechnic Ministry of Health Semarang
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
Health Polytechnic Ministry of Health Semarang
Address
Jl. Tirto Agung, Pedalangan, Kec. Banyumanik, Semarang City, Central Java
Tel
08562320225
kepk@poltekkes-smg.ac.id
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
Health Polytechnic Ministry of Health Semarang
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 25 | 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
| 2022 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 25 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2022 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056248
