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Supplementation of Galatonol 300 mg / Striatin 30 mg Combined Bioactive Fraction in Postpartum Lactating Mothers
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).
Age
18 - 35 years
Sex
FEMALE
Healthy Volunteers
Yes
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
Private Midwife Practice (Bidan Istri Utami)
Sleman, Special Region of Yogyakarta, Indonesia
Private Midwife Practice (Bidan Istri Yuliani)
Sleman, Special Region of Yogyakarta, Indonesia
Private Midwife Practice (Bidan Kisti)
Sleman, Special Region of Yogyakarta, Indonesia
Private Midwife Practice (Bidan Mei)
Sleman, Special Region of Yogyakarta, Indonesia
Private Midwife Practice (Bidan Tutik)
Sleman, Special Region of Yogyakarta, Indonesia
Private Midwife Practice (Bidan Wati)
Sleman, Special Region of Yogyakarta, Indonesia
Private Midwife Practice (Bidan Widya)
Sleman, Special Region of Yogyakarta, Indonesia
Start Date
October 21, 2024
Primary Completion Date
May 20, 2025
Completion Date
May 27, 2025
Last Updated
February 17, 2026
160
ACTUAL participants
Galatonol 300 mg/Striatin 30 mg
DRUG
Placebo
DRUG
Lead Sponsor
Dexa Medica Group
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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