Efficacy and Safety of Milk Secretory Supplement in Breas... | NCT05880589

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

NCT05880589

Sponsor

Chulalongkorn University

Status

Unknown status

Last Update Posted

May 30, 2023Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Lactation

Interventions

Milk secretory supplement group
Placebo group

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 8, 2022Actual

Primary Completion Date

Oct 31, 2023Estimated

Completion Date

Nov 10, 2023Estimated

First Submitted Date

May 19, 2023

First Submission Date that Met QC Criteria

May 19, 2023

First Posted Date

May 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2023

Last Update Posted Date

May 30, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn UniversityPrincipal Investigator

Lead Sponsor

Chulalongkorn UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Milk secretory supplement	Experimental	Milk secretory supplement composes of fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine.	Dietary Supplement: Milk secretory supplement group
Placebo group	Placebo Comparator	Placebo is tablet without fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine.	Dietary Supplement: Placebo group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Milk secretory supplement group	Dietary Supplement	Take 2 tablet 2 times per day for 14 days	Milk secretory supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of breast milk	Measure volume of breast milk (ml) (High volume means high efficacy)	14 days

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pornanong Aramwit, Professor	Contact	+66899217255		aramwit@gmail.com

Overall Officials

Name	Affiliation	Role
Pornanong Aramwit, Professor	Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pornanong Aramwit	Recruiting	Bangkok		10330	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D001942	Breast Feeding

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided