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The purpose of this study is assess the efficacy of ASIMOMMY® in increasing breast milk production in postpartum mothers.
Several traditional herbs have been used and is well known since a long time ago by Indonesian people to increase the production of breastmilk, such as Katuk leaves (Sauropus androgynous Folium), Fenugreek (Trigonella foenum-graceum), and Moringa leaves (Moringa oleifera Folium). These plants have been scientifically proven through preclinical and even clinical research. However, not many have been further developed as phytopharmaceuticals that can be used in formal health services.
In previous research, ASI MOMMY® capsules have been successfully produced in accordance to the traditional method of making good herbal drugs, with each capsule containing extracts of Katuk leaf (300 mg), Fenugreek (150 mg), and Moringa leaf (50 mg). This formulation has gone through pharmacodynamic activity test, and acute and subactute toxicity test. Research has shown that ASI MOMMY® is works actively as a galactogogue and is not toxic, therefore it is safe to be given to humans (unpublished),
No research has been done to test the benefits of ASI MOMMY® in increasinng breastmilk production. Therefore, this research is a clinical trial that intends to see the benefits of ASI MOMMY® for increasing breastmilk production in postpartum women. This research is a part of the previous main research that is still ongoing to this day which aims to develop the formulation of ASI MOMMY® as a phytopharmaceutical
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASIMOMMY® | Experimental | Experimental: 2 capsules of ASIMOMMY, orally one times daily from days 1 to 7 |
|
| Domperidone | Active Comparator | Domperidone capsule, one capsule, orally three times daily from days 1 to 7 |
|
| Placebo | Placebo Comparator | Identical 2 capsules of placeb, orally one times daily from days 1 to 7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASIMOMMY® | Drug | ASIMOMMY 500 mg |
| |
| Domperidon |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Neonates Weight | The primary outcome is the difference in the neonates weight after 7 days of treatment with ASIMOMMY® compared to mothers receiving domperidone and placebo (mean day 7 neonates weight minus mean day 0 neonates weight). | Day 0 to day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of non serious adverse event within 7 days | Number of mothers or neonates who had non serious adverse event from day 0 to day 7 with ASIMOMMY® compare to mother receiving Domperidone and Placebo | Day 0 to day 7 |
| Proportion of serious adverse event within 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Health Center Jetis and Tegalrejo | Yogyakarta | DI Yogyakarta | 55242 | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 18, 2022 | Oct 19, 2022 |
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| Drug |
Domperidone capsule 10 mg |
|
| Placebo | Drug | Capsules of placebo 500mg. |
|
Number of mothers or neonates who had serious adverse event from day 0 to day 7 with ASIMOMMY® compare to mother receiving Domperidone and Placebo |
| Day 0 to day 7 |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2022 | Oct 19, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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