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| Name | Class |
|---|---|
| Milte Italia SpA | UNKNOWN |
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The purpose of this study is to assess the effectiveness of a commercially available product containing a combination of Silybum marianum and Galega officinalis to support continuation or augmentation of breast milk production.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | a placebo identical in appearance to the galactagogue product |
|
| No treatment | No Intervention | Usual care and breastfeeding support | |
| Herbal galactagogue | Experimental | A commercially available product containing a combination of Silybum marianum 400 mg and Galega officinalis 150 mg, once a day for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herbal galactagogue | Dietary Supplement |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of mothers who exclusively breastfeed their child | At 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of breastfeeding (either exclusively or as a supplement to formula feeding ) | at 6 weeks and 3 months | |
| Volume (mL) and frequency (times a day) of formula | 6 weeks postpartum | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonella Cromi, MD | Contact | antonella.cromi@uninsubria.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Ospedale di Circolo e Fondazione Macchi, Presidio F. Del Ponte | Varese | 21100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32421208 | Derived | Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| Placebo |
| Dietary Supplement |
|
| weight gain experienced by the newborns |
| 6 weeks postpartum |
| serum prolactin level | at baseline and 6 weeks after treatment |
| Rate of maternal allergic reactions and gastrointestinal side effects | 6 weeks postpartum |