Supplementation of Galatonol 300 mg / Striatin 30 mg in Postpartum Lactating Mothers (NCT06558071) | Clinical Trial Compass
CompletedPhase 3
Supplementation of Galatonol 300 mg / Striatin 30 mg in Postpartum Lactating Mothers
Indonesia160 participantsStarted 2024-10-21
Plain-language 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.
Who can participate
Age range18 Years – 35 Years
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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