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

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

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

Study Overview

• Status: Recruiting
• Conditions: Lactation
• Intervention / Treatment: Dietary supplement: Milk secretory supplement group; Dietary supplement: Placebo group

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pornanong Aramwit, Professor; Phone Number: +66899217255; Email: aramwit@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • Pornanong Aramwit
    • Contact: Pornanong Aramwit, Professor; Phone Number: +66899217255; Email: aramwit@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Pornanong Aramwit, Professor, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): November 10, 2023

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SIRB710/2565

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No