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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
1 film-coated caplet of Herba Asimor, twice daily
1 film-coated caplet of placebo Herba Asimor, twice daily
Klinik Pratama Anugrah Sleman
Sleman, Special Region of Yogyakarta, Indonesia
Private Midwife Practice (Bidan Anisa)
Sleman, Special Region of Yogyakarta, Indonesia
Private Midwife Practice (Bidan Catur)
Sleman, Special Region of Yogyakarta, Indonesia
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
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Private Midwife Practice (Bidan Istri Utami)
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Private Midwife Practice (Bidan Istri Yuliani)
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Private Midwife Practice (Bidan Kisti)
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