Unique ID issued by UMIN | UMIN000010306 |
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Receipt number | R000012060 |
Scientific Title | Efficacy and safety of a galactagogue containing Sylimarin and Galega in mothers of preterm infants |
Date of disclosure of the study information | 2013/03/25 |
Last modified on | 2016/10/19 01:12:16 |
Efficacy and safety of a galactagogue containing Sylimarin and Galega in mothers of preterm infants
Galactagogue usefulness in mothers of preterm infants
Efficacy and safety of a galactagogue containing Sylimarin and Galega in mothers of preterm infants
Galactagogue usefulness in mothers of preterm infants
Europe |
prematurity
Pediatrics | Nursing | Child |
Others
NO
To verify efficacy and safety of a galactagogue containing Sylimarin and Galega in mothers of preterm infants during the first month of lactation.
Safety,Efficacy
Exploratory
Not applicable
To increase breast milk production by 25% in the treated arm compared with the placebo
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
YES
Numbered container method
2
Treatment
Medicine | Food | Other |
Galactagogue administration from the 3rd to the 28th day of life
Placebo administration from the 3rd to the 28th day of life
Not applicable |
Not applicable |
Male and Female
gestational age between 27+0 and 32+6 weeks
breast milk contraindication, lactose intolerance
100
1st name | |
Middle name | |
Last name | Enrico Zecca |
Catholic University of the Sacred Heart
Neonatology
Largo Gemelli 8, 00168 Rome, Italy
+39630154169
enrizecca@rm.unicatt.it
1st name | |
Middle name | |
Last name | Enrico Zecca |
Catholic University of the Sacred Heart
Neonatology
Largo Gemelli 8, 00168 Rome, Italy
+39630154169
enrizecca@rm.unicatt.it
Division of Neonatology, Catholic University of the Sacred Heart
Division of Neonatology, Catholic University of the Sacred Heart
Outside Japan
NO
2013 | Year | 03 | Month | 25 | Day |
Published
http://www.nature.com/ejcn/journal/v70/n10/full/ejcn201686a.html
50 mothers were included in each group. Milk production was significantly greater in the GG both at the 7th day of life and at the 30th day of life. The total production of milk during the study period was greater in the GG. No adverse reactions were noted in both the study groups. PiuLatte Plus increases milk production in mothers of preterm infants from the first days of treatment and throughout the first month of life without any significant side effects.
Completed
2013 | Year | 03 | Month | 25 | Day |
2013 | Year | 11 | Month | 15 | Day |
2015 | Year | 05 | Month | 31 | Day |
2015 | Year | 05 | Month | 31 | Day |
2015 | Year | 05 | Month | 31 | Day |
2015 | Year | 07 | Month | 15 | Day |
2013 | Year | 03 | Month | 22 | Day |
2016 | Year | 10 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012060
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