Lactation Induced
Conditions
Keywords
Lactating mothers, Galactagogues, Galatonol /Striatin Bioactive Fraction
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).
Interventions
DRUGGalatonol 300 mg/Striatin 30 mg
1 film-coated caplet of Herba Asimor, twice daily
DRUGPlacebo
1 film-coated caplet of placebo Herba Asimor, twice daily
Sponsors
Dexa Medica Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Oxytocin level | Day 8, Day 15 | Maternal oxytocin level at Day 8 and 15 of treatment |
| Prolactin level | Day 8, Day 15 | Maternal prolactin level at Day 8 and 15 of treatment |
| 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. |
| 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) |
| 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. |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORFenny Yunita, MD, MSi, PhD
Faculty of Medicine, Universitas Tarumanagara
Outcome results
None listed