Brief Summary

This is a randomized, double-blind, and placebo-controlled study involving mothers as the participant and participant's babies evaluating the effect of a 15-day-supplementation with a product containing extracts derived from a combination of herbal plants (katuk \& torbangun leaves) and snakehead fish in stimulating breast milk production.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

160

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Oct 2024

Shorter than P25 for phase_3

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7 months study duration

First Submitted

Initial submission to the registry

August 14, 2024

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2025

Completed

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

August 14, 2024

Last Update Submit

February 12, 2026

Conditions

Lactation Induced

Keywords

Lactating mothersGalactagoguesGalatonol /Striatin Bioactive Fraction

Outcome Measures

Primary Outcomes (1)

Infant weight
The sufficient breastmilk supply indicated by infant weight at Day 15 of treatment (i.e. 14 days after study treatment initation) relative to Baseline (infant weight at 24 Hour post-partum).
Day 15

Secondary Outcomes (6)

Infant weight
Day 8
Breastmilk production
Day 8, Day 15
Breastfeeding frequency
Day 8, Day 15
Prolactin level
Day 8, Day 15
Oxytocin level
Day 8, Day 15
+1 more secondary outcomes

Other Outcomes (10)

Infant's daily duration of sleeping
Day 8, Day 15
Qualitative self-assessment of breast-milk thicknes
Day 8, Day 15
Body temperature
Day 8, Day 15
+7 more other outcomes

Study Arms (2)

Investigational Group

EXPERIMENTAL

1 film-coated caplet (Galatonol 300 mg/Striatin 30 mg), twice daily, after morning and evening meals

Drug: Galatonol 300 mg/Striatin 30 mg

Control Group

PLACEBO COMPARATOR

1 film-coated caplet of Placebo, twice daily, after morning and evening meals

Drug: Placebo

Interventions

Galatonol 300 mg/Striatin 30 mgDRUG

1 film-coated caplet of Herba Asimor, twice daily

Also known as: Herba Asimor

Investigational Group

PlaceboDRUG

1 film-coated caplet of placebo Herba Asimor, twice daily

Control Group

Eligibility Criteria

Age18 Years - 35 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Signed informed consent prior to participation in the study.
Generally healthy women aged \>= 18-35 years.
Having a full-term gestational age (37- 40 weeks, inclusive).
The infant to breastfed: having normal birth body weight (2500-4000 gr).
Giving consent and commitment to pursue an exclusive breastfeeding
Willing to comply with the study protocol.
Spontaneous delivery.
Healthy newborn baby

You may not qualify if:

Difficult breastfeeding due to organic defect;
Suspected COVID-19 by clinical symptoms.
LATCH Score \< 4;
Choosing not to breastfeed due to other subjective or objective reasons;
Having multiple birth;
Known major medical complications during delivery;
Known to have breast diseases, such as: mastitis, or malignancies
Breastfeeding prohibited due to clindamycin injection within the past week.
History of smoking, alcohol drinking, or any drug abuse
Known to have any relevant chronic infections or illness and gestational diabetes;
Known to have disorders of major organs ;
Taking any medication or supplementation known to have galactagogue properties within the last trimester of pregnancy;
Taking any non-pharmacological complementary treatment within the last trimester of pregnancy aiming to affect breast milk production.
Participation in any other interventional clinical studies within 30 days prior to Screening.

Contact the study team to confirm eligibility.