Efficacy and Safety of Milk Secretory Supplement in Breast-feeding Volunteers
1 other identifier
interventional
24
1 country
1
Brief Summary
The objective of this study are to evaluate efficacy and safety of milk secretory supplement containing fenugreek, banana flower, and ginger extract in breast-feeding volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 8, 2022
CompletedFirst Submitted
Initial submission to the registry
May 19, 2023
CompletedFirst Posted
Study publicly available on registry
May 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2023
CompletedMay 30, 2023
May 1, 2023
11 months
May 19, 2023
May 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of breast milk
Measure volume of breast milk (ml) (High volume means high efficacy)
14 days
Secondary Outcomes (8)
Calcium in milk
14 days
Iron in milk
14 days
Docosahexaenoic acid in milk
14 days
Quality of life of volunteers
14 days
Skin reaction after taking supplement
14 days
- +3 more secondary outcomes
Study Arms (2)
Milk secretory supplement
EXPERIMENTALMilk secretory supplement composes of fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine.
Placebo group
PLACEBO COMPARATORPlacebo is tablet without fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine.
Interventions
Take 2 tablet 2 times per day for 14 days
Eligibility Criteria
You may qualify if:
- During lactation
- Using only breast pump
- No taking medicine or dietary that has an effect on milk secretary including domperidone, banana flower, fenugreek, and ginger in 48 hours
- No smoking and alcohol drinking
- Can read and write in Thai language
- Can meet researcher at the date of appointment
- No complication after delivering
You may not qualify if:
- Have uncontrolled diseases, cancer, or heart disease
- Have immunocompromised disease or use steroid in 2 weeks
- Allergic to fenugreek, banana flower, ginger, docosahexaenoic acid, iron, folate, and iodine
- Cannot follow the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pornanong Aramwit
Bangkok, 10330, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pornanong Aramwit, Professor
Chulalongkorn University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 19, 2023
First Posted
May 30, 2023
Study Start
December 8, 2022
Primary Completion
October 31, 2023
Study Completion
November 10, 2023
Last Updated
May 30, 2023
Record last verified: 2023-05