Weight GainGalactogogueNCT02740751
Efficacy of Herbal Galactogogues in Breastfeeding Mothers
A study testing Still-Tee in people with Weight Gain, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- Still-Tee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr Sami Ulus Children Hospital
Ankara, Ankara, 06120
Dilek Dilli, Assoc prof, 00903123056000 ext. 6310, dilekdilli2@yahoo.com
Selcan Yılmaz, MD
About this study
Official title: Efficacy of Herbal Galactogogues on Weight Gain of the Newborns Within the First Month of Life in Breastfeeding Mothers
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.
Read the detailed description
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
- Weight Gain
- Being tested
- Still-Tee
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Still-TeeDietary supplement
The mothers of the babies will receive Still-Tee galactogogue tea
| Study group | Role | What they receive |
|---|---|---|
| Still-Tee | Active comparator | 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 Receives: Dietary Supplement: Still-Tee |
| Placebo | Placebo comparator | The mothers of the babies will receive placebo tea which does not contain galactogogue herbs Receives: Dietary Supplement: Still-Tee |
| Water | No intervention | The mothers of the babies will receive water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: 4 weeks
Secondary outcomes (1)
Breast milk volume
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sami Ulus Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Dilli, Dr. Sami Ulus Children's Hospital
- Investigators
- Dilek Dilli, Assoc Prof, Study director, Dr Sami Ulus Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740751
- Sponsor's protocol ID
- SamiUlusCH-trials-stilltee
- Acronym
- Galactogogue
- Status last verified
- Apr 2016
- First submitted
- 12 Apr 2016
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32421208
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Herbal Galactogogues on Weight Gain of the Newborns Within the First Month of Life in Breastfeeding Mothers
- ClinicalTrials.gov ID
- NCT02740751
- Acronym / sponsor ID
- Galactogogue / SamiUlusCH-trials-stilltee
- Conditions
- Weight Gain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dr. Sami Ulus Children's HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Still-Tee | Active comparator | Dietary Supplement: Still-TeeGeneric 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 |
| Placebo | Placebo comparator | Dietary Supplement: Still-TeeThe mothers of the babies will receive placebo tea which does not contain galactogogue herbs |
| Water | No intervention | –The mothers of the babies will receive water |
Who may qualify
- Ages
- 3 to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Still-TeeThe mothers of the babies will receive Still-Tee galactogogue tea | Dietary supplement | Placebo, Still-Tee |
Primary outcome
Weight gain
Time frame: 4 weeks
1 secondary outcome
Breast milk volume
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Derived from this study: PubMed 32421208Foong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Dilli, Assoc Prof study director
Dr Sami Ulus Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Still-Tee in people with Weight Gain, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek Dilli, Assoc Prof (0903056310 ext. 6310, dilekdilli2@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02740751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.