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

Chulalongkorn University

Status: Enrolling

Conditions: Lactation

Treatments: Dietary Supplement: Milk secretory supplement group; Dietary Supplement: Placebo group

Study type: Interventional

Funder types: Other

Identifiers

NCT05880589

SIRB710/2565

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Milk secretory supplement

Experimental group

Description:

Milk secretory supplement composes of fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine.

Treatment:

Dietary Supplement: Milk secretory supplement group

Placebo group

Placebo Comparator group

Description:

Placebo is tablet without fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine.

Treatment:

Dietary Supplement: Placebo group