Efficacy of Herbal Galactogogues in Breastfeeding Mothers

NCT ID: NCT02740751

Last Updated: 2016-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-04-30

Brief Summary

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Herbal teas with galactogoge effects have been used extensively in recent years in order to increase the amount of breast milk in lactating mothers. We also investigated whether a sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these mothers. Plain water was used as placebo.

Detailed Description

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Herbal teas with galactogoge effects have been used extensively in recent years in order to increase the amount of breast milk in lactating mothers. Mothers of premature babies often have problems in breastfeeding and this study was designed to investigate if such herbal teas has any effect on the increasing of breast milk in mothers of premature babies. We also investigated whether a sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these mothers. Plain water was used as placebo.

Conditions

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Weight Gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Still-Tee

Generic name: galactogoe herbal tee, still-tee Dosage: Three cups (each 200 ml) of tea of Still-Tee galactogogue tea will be used Frequency: Three times in a day Duration: for 4 weeks after birth

Group Type ACTIVE_COMPARATOR

Still-Tee

Intervention Type DIETARY_SUPPLEMENT

The mothers of the babies will receive Still-Tee galactogogue tea

Placebo

The mothers of the babies will receive placebo tea which does not contain galactogogue herbs

Group Type PLACEBO_COMPARATOR

Still-Tee

Intervention Type DIETARY_SUPPLEMENT

The mothers of the babies will receive Still-Tee galactogogue tea

Water

The mothers of the babies will receive water

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Still-Tee

The mothers of the babies will receive Still-Tee galactogogue tea

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Babies with gestational age of 35-42 weeks
* Breasfed babies
* Lactating mothers
* Babies admitted to outpatient clinics of neonatology within the the first week of life

Exclusion Criteria

* Babies with gestational age of \<35 weeks
* Not breast feeding mothers
* Babies admitted to outpatient clinics of neonatology within the the first week of life
Minimum Eligible Age

3 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Sami Ulus Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dilek Dilli

MD, Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek Dilli, Assoc Prof

Role: STUDY_DIRECTOR

Dr Sami Ulus Research and Training Hospital

Locations

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Dr Sami Ulus Children Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Dilek Dilli, Assoc Prof

Role: CONTACT

0903056310 ext. 6310

Facility Contacts

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Dilek Dilli, Assoc prof

Role: primary

00903123056000 ext. 6310

References

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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.

Reference Type DERIVED
PMID: 32421208 (View on PubMed)

Other Identifiers

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SamiUlusCH-trials-stilltee

Identifier Type: -

Identifier Source: org_study_id

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