LactationNCT05880589
Efficacy and Safety of Milk Secretory Supplement in Breast-feeding Volunteers
A study testing Milk secretory supplement group in people with Lactation, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The objective of this study are to evaluate efficacy and safety of milk secretory supplement containing fenugreek, banana flower, and ginger extract in breast-feeding volunteers Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lactation
- What is being tested?
- Milk secretory supplement group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 8 Dec 2022to 10 Nov 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- During lactation
- Using only breast pump
- No taking medicine or dietary that has an effect on milk secretary including domperidone, banana flower, fenugreek, and ginger in 48 hours
- No smoking and alcohol drinking
- Can read and write in Thai language
- Can meet researcher at the date of appointment
- No complication after delivering
Who cannot join
- Have uncontrolled diseases, cancer, or heart disease
- Have immunocompromised disease or use steroid in 2 weeks
- Allergic to fenugreek, banana flower, ginger, docosahexaenoic acid, iron, folate, and iodine
- Cannot follow the protocol
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Pornanong Aramwit
Bangkok, 10330
Pornanong Aramwit, Professor, +66899217255, aramwit@gmail.com
About this study
Official title: Efficacy and Safety of Milk Secretory Supplement Containing Fenugreek, Banana Flower, and Ginger Extract in Breast-feeding Volunteers
The objective of this study are to evaluate efficacy and safety of milk secretory supplement containing fenugreek, banana flower, and ginger extract in breast-feeding volunteers
Read the detailed description
There are 24 volunteers in this study. They are randomly divided into 2 groups which are milk secretory supplement group and placebo group. The volunteers take 2 tablets of the sample 2 times/day for 14 days. Amount of breast milk, calcium, iron, docosahexaenoic acid, quality of life, adverse reaction, and satisfaction before taking and after taking for 14 days.
- Conditions
- Lactation
- Being tested
- Milk secretory supplement group, Placebo group
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk secretory supplement groupDietary supplement
Take 2 tablet 2 times per day for 14 days
Placebo groupDietary supplement
Take 2 tablet 2 times per day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Milk secretory supplement | Experimental | Milk secretory supplement composes of fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine. Receives: Dietary Supplement: Milk secretory supplement group |
| Placebo group | Placebo comparator | Placebo is tablet without fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of breast milk
Measure volume of breast milk (ml) (High volume means high efficacy)
Measured: 14 days
Secondary outcomes (8)
Calcium in milk
Calcium in milk (mg/100ml) (High amount means high efficacy)
Measured: 14 days
Iron in milk
Iron in milk (mg/100ml) (High amount means high efficacy)
Measured: 14 days
Docosahexaenoic acid in milk
Docosahexaenoic acid in milk (g/100ml) (High amount means high efficacy)
Measured: 14 days
Quality of life of volunteers
Use World Health Organization Quality of Life Brief - Thai questionnaire (0 to 4 scale means low to high quality of life)
Measured: 14 days
Skin reaction after taking supplement
Found or not found
Measured: 14 days
Gastrointestinal reaction after taking supplement
Found or not found
Measured: 14 days
Respiratory tract reaction after taking supplement
Found or not found
Measured: 14 days
Satisfaction after taking supplement
Use visual analogue scale (0 to 10 means lowest to highest satisfaction)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start8 Dec 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion10 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
- Investigators
- Pornanong Aramwit, Professor, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880589
- Sponsor's protocol ID
- SIRB710/2565
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Milk Secretory Supplement Containing Fenugreek, Banana Flower, and Ginger Extract in Breast-feeding Volunteers
- ClinicalTrials.gov ID
- NCT05880589
- Acronym / sponsor ID
- SIRB710/2565
- Conditions
- Lactation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 10 Nov 2023 (estimated)
- First posted
- 30 May 2023 (actual)
- 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.
The objective of this study are to evaluate efficacy and safety of milk secretory supplement containing fenugreek, banana flower, and ginger extract in breast-feeding volunteers
Detailed description
There are 24 volunteers in this study. They are randomly divided into 2 groups which are milk secretory supplement group and placebo group. The volunteers take 2 tablets of the sample 2 times/day for 14 days. Amount of breast milk, calcium, iron, docosahexaenoic acid, quality of life, adverse reaction, and satisfaction before taking and after taking for 14 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk secretory supplement | Experimental | Dietary Supplement: Milk secretory supplement groupMilk secretory supplement composes of fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine. |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupPlacebo is tablet without fenugreek, banana flower, ginger extract, docosahexaenoic acid, iron, folate, and iodine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- During lactation
- Using only breast pump
- No taking medicine or dietary that has an effect on milk secretary including domperidone, banana flower, fenugreek, and ginger in 48 hours
- No smoking and alcohol drinking
- Can read and write in Thai language
Key exclusion criteria (4 listed)
- Have uncontrolled diseases, cancer, or heart disease
- Have immunocompromised disease or use steroid in 2 weeks
- Allergic to fenugreek, banana flower, ginger, docosahexaenoic acid, iron, folate, and iodine
- Cannot follow the protocol
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 |
|---|---|---|
| Milk secretory supplement groupTake 2 tablet 2 times per day for 14 days | Dietary supplement | Milk secretory supplement |
| Placebo groupTake 2 tablet 2 times per day for 14 days | Dietary supplement | Placebo group |
Primary outcome
Amount of breast milk
Time frame: 14 days
Measure volume of breast milk (ml) (High volume means high efficacy)
8 secondary outcomes
Calcium in milk
Time frame: 14 days
Iron in milk
Time frame: 14 days
Docosahexaenoic acid in milk
Time frame: 14 days
Quality of life of volunteers
Time frame: 14 days
Skin reaction after taking supplement
Time frame: 14 days
Gastrointestinal reaction after taking supplement
Time frame: 14 days
Respiratory tract reaction after taking supplement
Time frame: 14 days
Satisfaction after taking supplement
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
Related trials for Lactation
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
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.
Pornanong Aramwit, Professor principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk secretory supplement group in people with Lactation, run by Chulalongkorn University at 1 site in Thailand.
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 7 inclusion and 4 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 30 May 2023. 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 Thailand. 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 Pornanong Aramwit, Professor (+66899217255, aramwit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of breast milk (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.