Efficacy and Safety of Milk Secretory Supplement in Breast-feeding Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Milk Secretory Supplement Containing Fenugreek, Banana Flower, and Ginger Extract in Breast-feeding Volunteers

Conditions
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Lactation

Intervention / Treatment
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* Dietary Supplement: Milk secretory supplement group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milk secretory supplement<br>Milk secretory supplement composes of fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine. | Dietary Supplement: Milk secretory supplement group<br>* Take 2 tablet 2 times per day for 14 days<br>|
| Placebo Comparator: Placebo group<br>Placebo is tablet without fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine. | Dietary Supplement: Placebo group<br>* Take 2 tablet 2 times per day for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of breast milk | Measure volume of breast milk (ml) (High volume means high efficacy) | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium in milk | Calcium in milk (mg/100ml) (High amount means high efficacy) | 14 days | 
| Iron in milk | Iron in milk (mg/100ml) (High amount means high efficacy) | 14 days | 
| Docosahexaenoic acid in milk | Docosahexaenoic acid in milk (g/100ml) (High amount means high efficacy) | 14 days | 
| Quality of life of volunteers | Use World Health Organization Quality of Life Brief - Thai questionnaire (0 to 4 scale means low to high quality of life) | 14 days | 
| Skin reaction after taking supplement | Found or not found | 14 days | 
| Gastrointestinal reaction after taking supplement | Found or not found | 14 days | 
| Respiratory tract reaction after taking supplement | Found or not found | 14 days | 
| Satisfaction after taking supplement | Use visual analogue scale (0 to 10 means lowest to highest satisfaction) | 14 days |