Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues

Università degli Studi dell'Insubria

Status: Unknown

Conditions: Breastfeeding

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Herbal galactagogue

Study type: Interventional

Funder types: Other

Identifiers

NCT02233439

IRB 54/2013

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• singleton, term delivery
• >2.5 kg newborn weight
• lactation-deficiency

Exclusion criteria

• Neonatal Intensive Care Unit admission
• use of galactagogue drugs
• allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

a placebo identical in appearance to the galactagogue product

Treatment:

Dietary Supplement: Placebo

No treatment

No Intervention group

Description:

Usual care and breastfeeding support

Herbal galactagogue

Experimental group

Description:

A commercially available product containing a combination of Silybum marianum 400 mg and Galega officinalis 150 mg, once a day for 6 weeks

Treatment:

Dietary Supplement: Herbal galactagogue