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

Not Applicable

Recruiting

• Conditions: Lactation
• Interventions: Dietary Supplement: Placebo group; Dietary Supplement: Milk secretory supplement group

• Registration Number: NCT05880589
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Study Start: 2022-12-08
• Status Verified: 2023-05
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study First Posted: 2023-05-30
• Last Update Posted: 2023-05-30
• Primary Completion: 2023-10-31
• Study Completion: 2023-11-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo group	Placebo is tablet without fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine.
Milk secretory supplement	Milk secretory supplement group	Milk secretory supplement composes of fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine.

Primary Outcome Measures

Name	Time	Method
Amount of breast milk	14 days	Measure volume of breast milk (ml) (High volume means high efficacy)

Secondary Outcome Measures

Name	Time	Method
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)
Iron in milk	14 days	Iron in milk (mg/100ml) (High amount means high efficacy)
Calcium in milk	14 days	Calcium 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)
Skin 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)
Respiratory tract reaction after taking supplement	14 days	Found or not found
Gastrointestinal reaction after taking supplement	14 days	Found or not found

Trial Locations

Locations (1)

Pornanong Aramwit; 🇹🇭 Bangkok, Thailand