Supplementation of Galatonol 300 mg / Striatin 30 mg in Postpartum Lactating Mothers
NCT Number: NCT06558071
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Lactation Induced
Interventions: DRUG: Galatonol 300 mg/Striatin 30 mg|DRUG: Placebo
Sponsor: Dexa Medica Group
Sex: FEMALE
Age: ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-04
Locations: Klinik Pratama Anugrah Sleman, Sleman, Daerah Istimewa Yogyakarta, Indonesia|Private Midwife Practice (Bidan Anisa), Sleman, Daerah Istimewa Yogyakarta, Indonesia|Private Midwife Practice (Bidan Catur), Sleman, Daerah Istimewa Yogyakarta, Indonesia|Private Midwife Practice (Bidan Istri Utami), Sleman, Daerah Istimewa Yogyakarta, Indonesia|Private Midwife Practice (Bidan Istri Yuliani), Sleman, Daerah Istimewa Yogyakarta, Indonesia|Private Midwife Practice (Bidan Kisti), Sleman, Daerah Istimewa Yogyakarta, Indonesia|Private Midwife Practice (Bidan Mei), Sleman, Daerah Istimewa Yogyakarta, Indonesia|Private Midwife Practice (Bidan Tutik), Sleman, Daerah Istimewa Yogyakarta, Indonesia|Private Midwife Practice (Bidan Wati), Sleman, Daerah Istimewa Yogyakarta, Indonesia|Private Midwife Practice (Bidan Widya), Sleman, Daerah Istimewa Yogyakarta, Indonesia

Summary:
This is a randomized, double-blind and placebo-controlled study involving mothers and their 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.

Primary Outcome Measures: 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 Outcome Measures: Infant weight, Infant weight at Day 8 of treatment (i.e. 7 days after study treatment initation) relative to Baseline., 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., 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), Day 8, Day 15|Prolactin level, Maternal prolactin level at Day 8 and 15 of treatment, Day 8, Day 15|Oxytocin level, Maternal oxytocin level at Day 8 and 15 of treatment, 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, Day 8, Day 15
Other Outcome Measures: 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., 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., Day 8, Day 15|Body temperature, Body temperature measurement as a vital sign safety parameter., Day 8, Day 15|Blood pressure, Blood pressure will be measured as a vital sign safety parameter., Day 8, Day 15|Heart rate and respiratory rate, Heart rate and respiratory rate will be measured as a vital sign safety parameter., Day 8, Day 15|Random plasma glucose, Random plasma glucose will be measured as a safety parameter., Day 8, Day 15|Liver function, Liver function measurements include: serum alanine aminotransferase \[ALT\] and serum aspartate aminotransferase \[AST\]., Day 15|Renal function, Renal function measurements include: serum creatinine, 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, Day 15|Adverse events, Tolerability to the study product will be assessed through the evaluation of adverse events along the study period., Day 3, Day 8, Day 15