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

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.

Study Overview

• Status: Completed
• Conditions: Lactation Induced
• Intervention / Treatment: Drug: Galatonol 300 mg/Striatin 30 mg; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Special Region of Yogyakarta
    • Sleman, Special Region of Yogyakarta, Indonesia
      • 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)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Signed informed consent prior to participation in the study.
2. Generally healthy women aged >= 18-35 years.
3. Having a full-term gestational age (37- 40 weeks, inclusive).
4. The infant to breastfed: having normal birth body weight (2500-4000 gr).
5. Giving consent and commitment to pursue an exclusive breastfeeding
6. Willing to comply with the study protocol.
7. Spontaneous delivery.
8. Healthy newborn baby

Exclusion Criteria:

1. Difficult breastfeeding due to organic defect;
2. Suspected COVID-19 by clinical symptoms.
3. LATCH Score < 4;
4. Choosing not to breastfeed due to other subjective or objective reasons;
5. Having multiple birth;
6. Known major medical complications during delivery;
7. Known to have breast diseases, such as: mastitis, or malignancies
8. Breastfeeding prohibited due to clindamycin injection within the past week.
9. History of smoking, alcohol drinking, or any drug abuse
10. Known to have any relevant chronic infections or illness and gestational diabetes;
11. Known to have disorders of major organs ;
12. Taking any medication or supplementation known to have galactagogue properties within the last trimester of pregnancy;
13. Taking any non-pharmacological complementary treatment within the last trimester of pregnancy aiming to affect breast milk production.
14. Participation in any other interventional clinical studies within 30 days prior to Screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Group; 1 film-coated caplet (Galatonol 300 mg/Striatin 30 mg), twice daily, after morning and evening meals	Drug: Galatonol 300 mg/Striatin 30 mg; 1 film-coated caplet of Herba Asimor, twice daily; Other Names: Herba Asimor
Placebo Comparator: Control Group; 1 film-coated caplet of Placebo, twice daily, after morning and evening meals	Drug: Placebo; 1 film-coated caplet of placebo Herba Asimor, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Investigators: Principal Investigator: Fenny Yunita, MD, MSi, PhD, Faculty of Medicine, Universitas Tarumanagara

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Actual): May 20, 2025
• Study Completion (Actual): May 27, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Lactating mothers; Galactagogues; Galatonol /Striatin Bioactive Fraction
• Other Study ID Numbers: ASM-0120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No