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

Lactation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880589
• Other study ID #: SIRB710/2565
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2022
• Est. completion date: November 10, 2023

Study information

• Verified date: May 2023
• Source: Chulalongkorn University
• Contact: Pornanong Aramwit, Professor
• Phone: +66899217255
• Email: aramwit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: November 10, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lactation

Intervention

Dietary Supplement:
• Milk secretory supplement group
Take 2 tablet 2 times per day for 14 days
• Placebo group
Take 2 tablet 2 times per day for 14 days

Locations

Country	Name	City	State
Thailand	Pornanong Aramwit	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of breast milk	Measure volume of breast milk (ml) (High volume means high efficacy)	14 days
Secondary	Calcium in milk	Calcium in milk (mg/100ml) (High amount means high efficacy)	14 days
Secondary	Iron in milk	Iron in milk (mg/100ml) (High amount means high efficacy)	14 days
Secondary	Docosahexaenoic acid in milk	Docosahexaenoic acid in milk (g/100ml) (High amount means high efficacy)	14 days
Secondary	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
Secondary	Skin reaction after taking supplement	Found or not found	14 days
Secondary	Gastrointestinal reaction after taking supplement	Found or not found	14 days
Secondary	Respiratory tract reaction after taking supplement	Found or not found	14 days
Secondary	Satisfaction after taking supplement	Use visual analogue scale (0 to 10 means lowest to highest satisfaction)	14 days