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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05880589
Other study ID # SIRB710/2565
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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