A Phase 3 interventional study of Galatonol 300 mg/Striatin 30 mg and Placebo in Lactation Induced, sponsored by Dexa Medica Group. Completed at 10 sites in Indonesia. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Dexa Medica Group · Phase 3, Interventional, and Treatment
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.
The study product is a herbal product containing 300 mg Galatonol bioactive fraction, enriched with 30 mg Striatin bioactive fraction. This lactation supplement has been granted the marketing authorization from Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM RI) as traditional medicine with the indication to enhance breast milk production.
A total of 160 subjects (80 subjects in each group) who have just partus, are planned to participate in this study. Eligible subjects will be allocated in a random and blinded fashion to receive one of the two products (study product or placebo) and to come for follow-up visits at Day 4, 8 and 15 (End of Study).
Dexa Medica Group is the lead sponsor of 39 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 film-coated caplet (Galatonol 300 mg/Striatin 30 mg), twice daily, after morning and evening meals
Drug: Galatonol 300 mg/Striatin 30 mg
1 film-coated caplet of Placebo, twice daily, after morning and evening meals
Drug: Placebo
1 film-coated caplet of Herba Asimor, twice daily
Also known as: Herba Asimor
1 film-coated caplet of placebo Herba Asimor, twice daily
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).
Time frame: Day 15
Infant weight
Infant weight at Day 8 of treatment (i.e. 7 days after study treatment initation) relative to Baseline.
Time frame: Day 8
Breastmilk production
Breastmilk production at Day 8 and Day 15 of treatment (i.e. 7, and 14 days after study treatment initiation) as represented by three-hourly breast milk volume.
Time frame: Day 8, Day 15
Breastfeeding frequency
Mean breastfeeding frequency per 24 hours up to Day 8 and Day 15 of treatment (i.e. 7 and 14 days after study treatment initiation, respectively)
Time frame: Day 8, Day 15
Prolactin level
Maternal prolactin level at Day 8 and 15 of treatment
Time frame: Day 8, Day 15
Oxytocin level
Maternal oxytocin level at Day 8 and 15 of treatment
Time frame: Day 8, Day 15
Frequency of infant void and stool
Mean daily frequency of infant void and stool up to Day 8 and 15 of treatment
Time frame: Day 8, Day 15
Infant's daily duration of sleeping
Infant's daily duration of sleeping will be evaluated as exploratory endpoint at Day 8 and 15 of treatment.
Time frame: Day 8, Day 15
Qualitative self-assessment of breast-milk thicknes
Qualitative self-assessment of breast-milk thickness will be evaluated as exploratory endpoint at Day 8 and 15 of treatment.
Time frame: Day 8, Day 15
Body temperature
Body temperature measurement as a vital sign safety parameter.
Time frame: Day 8, Day 15
Blood pressure
Blood pressure will be measured as a vital sign safety parameter.
Time frame: Day 8, Day 15
Heart rate and respiratory rate
Heart rate and respiratory rate will be measured as a vital sign safety parameter.
Time frame: Day 8, Day 15
Random plasma glucose
Random plasma glucose will be measured as a safety parameter.
Time frame: Day 8, Day 15
Liver function
Liver function measurements include: serum alanine aminotransferase \[ALT\] and serum aspartate aminotransferase \[AST\].
Time frame: Day 15
Renal function
Renal function measurements include: serum creatinine
Time frame: Day 15
Complete blood count
Complete blood count measurements include: hemoglobin, hematocrit, red blood cell \[RBC\], white blood cell \[WBC\], differentiation of WBC, erythrocyte sedimentation rate \[ESR\], platelet count
Time frame: Day 15
Adverse events
Tolerability to the study product will be assessed through the evaluation of adverse events along the study period.
Time frame: Day 3, Day 8, Day 15
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Dexa Medica Group