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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-08

Study Completion Date

2023-11-10

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

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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.

Conditions

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Lactation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Milk secretory supplement

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

Group Type EXPERIMENTAL

Milk secretory supplement group

Intervention Type DIETARY_SUPPLEMENT

Take 2 tablet 2 times per day for 14 days

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type DIETARY_SUPPLEMENT

Take 2 tablet 2 times per day for 14 days

Interventions

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Milk secretory supplement group

Take 2 tablet 2 times per day for 14 days

Intervention Type DIETARY_SUPPLEMENT

Placebo group

Take 2 tablet 2 times per day for 14 days

Intervention Type DIETARY_SUPPLEMENT

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes