NCT06558071

Supplementation of Galatonol 300 mg / Striatin 30 mg in Postpartum Lactating Mothers

Supplementation of Galatonol 300 mg / Striatin 30 mg Combined Bioactive Fraction in Postpartum Lactating Mothers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

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).

Conditions

• Lactation Induced

Interventions

Type	Name	Description
DRUG	Galatonol 300 mg/Striatin 30 mg	1 film-coated caplet of Herba Asimor, twice daily
DRUG	Placebo	1 film-coated caplet of placebo Herba Asimor, twice daily

Timeline

• Start date: 2024-10-21
• Primary completion: 2025-05-20
• Completion: 2025-05-27
• First posted: 2024-08-16
• Last updated: 2026-02-17

Locations

10 sites across 1 country: Indonesia