Status:
RECRUITING
Supplementation of Galatonol 300 mg / Striatin 30 mg in Postpartum Lactating Mothers
Lead Sponsor:
Dexa Medica Group
Conditions:
Lactation Induced
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
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 containi...
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 authoriz...
Eligibility Criteria
Inclusion
- Signed informed consent prior to participation in the study.
- Generally healthy women aged \>= 18-35 years.
- Having a full-term gestational age (37- 40 weeks, inclusive).
- The infant to breastfed: having normal birth body weight (2500-4000 gr).
- Giving consent and commitment to pursue an exclusive breastfeeding
- Willing to comply with the study protocol.
- Spontaneous delivery.
- Healthy newborn baby
Exclusion
- Difficult breastfeeding due to organic defect;
- Suspected COVID-19 by clinical symptoms.
- LATCH Score \< 4;
- Choosing not to breastfeed due to other subjective or objective reasons;
- Having multiple birth;
- Known major medical complications during delivery;
- Known to have breast diseases, such as: mastitis, or malignancies
- Breastfeeding prohibited due to clindamycin injection within the past week.
- History of smoking, alcohol drinking, or any drug abuse
- Known to have any relevant chronic infections or illness and gestational diabetes;
- Known to have disorders of major organs ;
- Taking any medication or supplementation known to have galactagogue properties within the last trimester of pregnancy;
- Taking any non-pharmacological complementary treatment within the last trimester of pregnancy aiming to affect breast milk production.
- Participation in any other interventional clinical studies within 30 days prior to Screening.
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06558071
Start Date
October 21 2024
End Date
June 1 2025
Last Update
February 7 2025
Active Locations (10)
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1
Klinik Pratama Anugrah Sleman
Sleman, Special Region of Yogyakarta, Indonesia
2
Private Midwife Practice (Bidan Anisa)
Sleman, Special Region of Yogyakarta, Indonesia
3
Private Midwife Practice (Bidan Catur)
Sleman, Special Region of Yogyakarta, Indonesia
4
Private Midwife Practice (Bidan Istri Utami)
Sleman, Special Region of Yogyakarta, Indonesia