Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Group | Experimental | 1 film-coated caplet (Galatonol 300 mg/Striatin 30 mg), twice daily, after morning and evening meals |
|
| Control Group | Placebo Comparator | 1 film-coated caplet of Placebo, twice daily, after morning and evening meals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galatonol 300 mg/Striatin 30 mg | Drug | 1 film-coated caplet of Herba Asimor, twice daily |
|
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fenny Yunita, MD, MSi, PhD | Faculty of Medicine, Universitas Tarumanagara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Pratama Anugrah Sleman | Sleman | Special Region of Yogyakarta | Indonesia | |||
| Private Midwife Practice (Bidan Anisa) |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 1 film-coated caplet of placebo Herba Asimor, twice daily |
|
| 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 |
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 |
| 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) | Sleman | Special Region of Yogyakarta | Indonesia |