Supplementation of herbal extracts to enhance breast milk production in postpartum mothers

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

This study is testing if a herbal supplement can help new mothers produce more breast milk after giving birth.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 35 Years
• Sex: Female
• Sponsor: Dexa Medica Group (Industry-sponsored)
• Locations: 10 sites (Sleman, Daerah Istimewa Yogyakarta and 9 other locations)
• Trial ID: NCT06558071 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled study evaluates the effects of a 15-day supplementation with a herbal product containing 300 mg of Galatonol and 30 mg of Striatin on breast milk production in postpartum lactating mothers. A total of 160 healthy women aged 18-35 who have recently given birth will be randomly assigned to receive either the herbal supplement or a placebo. Participants will attend follow-up visits at Days 4, 8, and 15 to monitor the effects on lactation. The product has been authorized as traditional medicine in Indonesia for enhancing breast milk production.

Who should consider this trial

Good fit: Ideal candidates are healthy postpartum women aged 18-35 who are committed to exclusive breastfeeding and have a healthy newborn.

Not a fit: Patients who have difficulties breastfeeding due to organic defects or other medical complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve breast milk production in postpartum mothers, benefiting both mothers and their infants.

How similar studies have performed: Other studies have shown positive outcomes with similar herbal supplementation approaches for enhancing lactation, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Sleman, Daerah Istimewa Yogyakarta and 9 other locations

• Klinik Pratama Anugrah Sleman — Sleman, Daerah Istimewa Yogyakarta, Indonesia (Recruiting)
• Private Midwife Practice (Bidan Anisa) — Sleman, Daerah Istimewa Yogyakarta, Indonesia (Recruiting)
• Private Midwife Practice (Bidan Catur) — Sleman, Daerah Istimewa Yogyakarta, Indonesia (Recruiting)
• Private Midwife Practice (Bidan Istri Utami) — Sleman, Daerah Istimewa Yogyakarta, Indonesia (Recruiting)
• Private Midwife Practice (Bidan Istri Yuliani) — Sleman, Daerah Istimewa Yogyakarta, Indonesia (Recruiting)
• Private Midwife Practice (Bidan Kisti) — Sleman, Daerah Istimewa Yogyakarta, Indonesia (Recruiting)
• Private Midwife Practice (Bidan Mei) — Sleman, Daerah Istimewa Yogyakarta, Indonesia (Recruiting)
• Private Midwife Practice (Bidan Tutik) — Sleman, Daerah Istimewa Yogyakarta, Indonesia (Recruiting)
• Private Midwife Practice (Bidan Wati) — Sleman, Daerah Istimewa Yogyakarta, Indonesia (Recruiting)
• Private Midwife Practice (Bidan Widya) — Sleman, Daerah Istimewa Yogyakarta, Indonesia (Recruiting)

Study contacts

• Principal investigator: Fenny Yunita, MD, MSi, PhD — Faculty of Medicine, Universitas Tarumanagara
• Study coordinator: Fenny Yunita, MD, MSi, PhD

Conditions Lactation Induced; Lactating mothers; Galactagogues; Galatonol /Striatin Bioactive Fraction