Lactation
Conditions
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
Detailed description
There are 24 volunteers in this study. They are randomly divided into 2 groups which are milk secretory supplement group and placebo group. The volunteers take 2 tablets of the sample 2 times/day for 14 days. Amount of breast milk, calcium, iron, docosahexaenoic acid, quality of life, adverse reaction, and satisfaction before taking and after taking for 14 days.
Interventions
DIETARY_SUPPLEMENTMilk secretory supplement group
Take 2 tablet 2 times per day for 14 days
DIETARY_SUPPLEMENTPlacebo group
Take 2 tablet 2 times per day for 14 days
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of breast milk | 14 days | Measure volume of breast milk (ml) (High volume means high efficacy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iron in milk | 14 days | Iron in milk (mg/100ml) (High amount means high efficacy) |
| Docosahexaenoic acid in milk | 14 days | Docosahexaenoic acid in milk (g/100ml) (High amount means high efficacy) |
| Quality of life of volunteers | 14 days | Use World Health Organization Quality of Life Brief - Thai questionnaire (0 to 4 scale means low to high quality of life) |
| Calcium in milk | 14 days | Calcium in milk (mg/100ml) (High amount means high efficacy) |
| Gastrointestinal reaction after taking supplement | 14 days | Found or not found |
| Respiratory tract reaction after taking supplement | 14 days | Found or not found |
| Satisfaction after taking supplement | 14 days | Use visual analogue scale (0 to 10 means lowest to highest satisfaction) |
| Skin reaction after taking supplement | 14 days | Found or not found |
Countries
Thailand
Contacts
Primary ContactPornanong Aramwit, Professor
Outcome results
None listed