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

Phase 3

Recruiting

• Conditions: Lactation Induced
• Interventions: Drug: Galatonol 300 mg/Striatin 30 mg; Drug: Placebo

• Registration Number: NCT06558071
• Lead Sponsor: Dexa Medica Group

Brief 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).

Study Timeline

• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-16
• Study Start: 2024-10-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Group	Galatonol 300 mg/Striatin 30 mg	1 film-coated caplet (Galatonol 300 mg/Striatin 30 mg), twice daily, after morning and evening meals
Control Group	Placebo	1 film-coated caplet of Placebo, twice daily, after morning and evening meals

Primary Outcome Measures

Name	Time	Method
Infant weight	Day 15	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).

Secondary Outcome Measures

Name	Time	Method
Breastfeeding frequency	Day 8, Day 15	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)
Breastmilk production	Day 8, Day 15	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.
Frequency of infant void and stool	Day 8, Day 15	Mean daily frequency of infant void and stool up to Day 8 and 15 of treatment
Infant weight	Day 8	Infant weight at Day 8 of treatment (i.e. 7 days after study treatment initation) relative to Baseline.
Prolactin level	Day 8, Day 15	Maternal prolactin level at Day 8 and 15 of treatment
Oxytocin level	Day 8, Day 15	Maternal oxytocin level at Day 8 and 15 of treatment

Trial Locations

Locations (10)

Klinik Pratama Anugrah Sleman; 🇮🇩 Sleman, Daerah Istimewa Yogyakarta, Indonesia

Private Midwife Practice (Bidan Anisa); 🇮🇩 Sleman, Daerah Istimewa Yogyakarta, Indonesia

Private Midwife Practice (Bidan Catur); 🇮🇩 Sleman, Daerah Istimewa Yogyakarta, Indonesia

Private Midwife Practice (Bidan Istri Utami); 🇮🇩 Sleman, Daerah Istimewa Yogyakarta, Indonesia

Private Midwife Practice (Bidan Istri Yuliani); 🇮🇩 Sleman, Daerah Istimewa Yogyakarta, Indonesia

Private Midwife Practice (Bidan Kisti); 🇮🇩 Sleman, Daerah Istimewa Yogyakarta, Indonesia

Private Midwife Practice (Bidan Mei); 🇮🇩 Sleman, Daerah Istimewa Yogyakarta, Indonesia

Private Midwife Practice (Bidan Tutik); 🇮🇩 Sleman, Daerah Istimewa Yogyakarta, Indonesia

Private Midwife Practice (Bidan Wati); 🇮🇩 Sleman, Daerah Istimewa Yogyakarta, Indonesia

Private Midwife Practice (Bidan Widya); 🇮🇩 Sleman, Daerah Istimewa Yogyakarta, Indonesia