Breastfeeding MothersPhase 2NCT05596006
Efficacy of ASIMOMMY® Compared to Domperidone and Placebo in Increasing Breastfeeding: Randomized Single-Blind Controlled Trial in Indonesia
A Phase 2 study testing ASIMOMMY® and Domperidon in people with Breastfeeding Mothers, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
The purpose of this study is assess the efficacy of ASIMOMMY® in increasing breast milk production in postpartum mothers. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Mothers
- What is being tested?
- ASIMOMMY® and Domperidon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIndonesia
- Study dates
- 31 Dec 2022to 24 Mar 2023
- Phase
- Phase 2
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mothers 20-35 years old.
- Gestational age at delivery 37-40 weeks.
- Vaginal delivery.
- Normal body mass index (BMI 18.5-24.9 kg/m2).
- Not taking drugs or breast milk enhancement supplements.
- Healthy mother's condition with normal nipples (protruding).
- Healthy baby condition with good suction reflex.
- The baby consumes only breast milk.
Who cannot join
- Allergy to ASI MOMMY® and Domperidon.
- The mother is taking medications that affect the effects of domperidone (such as antacids, cimetidine, ranitidine, famotidine and nizatidine) or medications that interact with domperidone (such as haloperidol, lithium).
- The mother is in a state of illness requiring hospitalization.
- Mother has HIV AIDS, heart problems, mastitis, and had undergone breast surgery.
- Underweight, overweight and obese mothers.
- Giving birth to twins.
- The baby has a congenital defect that affects the suctioning process of breast milk
- Infants and mothers who did not participate in the treatment until completion (day 7 of the intervention).
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Primary Health Center Jetis and Tegalrejo
Yogyakarta, DI Yogyakarta, 55242
About this study
The purpose of this study is assess the efficacy of ASIMOMMY® in increasing breast milk production in postpartum mothers.
Read the detailed description
Several traditional herbs have been used and is well known since a long time ago by Indonesian people to increase the production of breastmilk, such as Katuk leaves (Sauropus androgynous Folium), Fenugreek (Trigonella foenum-graceum), and Moringa leaves (Moringa oleifera Folium). These plants have been scientifically proven through preclinical and even clinical research. However, not many have been further developed as phytopharmaceuticals that can be used in formal health services.
In previous research, ASI MOMMY® capsules have been successfully produced in accordance to the traditional method of making good herbal drugs, with each capsule containing extracts of Katuk leaf (300 mg), Fenugreek (150 mg), and Moringa leaf (50 mg). This formulation has gone through pharmacodynamic activity test, and acute and subactute toxicity test. Research has shown that ASI MOMMY® is works actively as a galactogogue and is not toxic, therefore it is safe to be given to humans (unpublished),
No research has been done to test the benefits of ASI MOMMY® in increasinng breastmilk production. Therefore, this research is a clinical trial that intends to see the benefits of ASI MOMMY® for increasing breastmilk production in postpartum women. This research is a part of the previous main research that is still ongoing to this day which aims to develop the formulation of ASI MOMMY® as a phytopharmaceutical
- Conditions
- Breastfeeding Mothers
- Being tested
- ASIMOMMY®, Domperidon, Placebo
- Keywords
- breastmilk, domperidone, neonates, ASIMOMMY®, Poly Herbal Formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASIMOMMY®Drug
ASIMOMMY 500 mg
DomperidonDrug
Domperidone capsule 10 mg
PlaceboDrug
Capsules of placebo 500mg.
| Study group | Role | What they receive |
|---|---|---|
| ASIMOMMY® | Experimental | Experimental:
2 capsules of ASIMOMMY, orally one times daily from days 1 to 7 Receives: Drug: ASIMOMMY® |
| Domperidone | Active comparator | Domperidone capsule, one capsule, orally three times daily from days 1 to 7 Receives: Drug: Domperidon |
| Placebo | Placebo comparator | Identical 2 capsules of placeb, orally one times daily from days 1 to 7 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Neonates Weight
The primary outcome is the difference in the neonates weight after 7 days of treatment with ASIMOMMY® compared to mothers receiving domperidone and placebo (mean day 7 neonates weight minus mean day 0 neonates weight).
Measured: Day 0 to day 7
Secondary outcomes (2)
Proportion of non serious adverse event within 7 days
Number of mothers or neonates who had non serious adverse event from day 0 to day 7 with ASIMOMMY® compare to mother receiving Domperidone and Placebo
Measured: Day 0 to day 7
Proportion of serious adverse event within 7 days
Number of mothers or neonates who had serious adverse event from day 0 to day 7 with ASIMOMMY® compare to mother receiving Domperidone and Placebo
Measured: Day 0 to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start31 Dec 2022
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding MothersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andini Juwan Prabandari, MD, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596006
- Sponsor's protocol ID
- KE/FK/0191/EC/2022
- Status last verified
- Mar 2023
- First submitted
- 23 Oct 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ASIMOMMY® Compared to Domperidone and Placebo in Increasing Breastfeeding: Randomized Single-Blind Controlled Trial in Indonesia
- ClinicalTrials.gov ID
- NCT05596006
- Acronym / sponsor ID
- KE/FK/0191/EC/2022
- Conditions
- Breastfeeding Mothers
- Keywords
- breastmilk, domperidone, neonates, ASIMOMMY®, Poly Herbal Formulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 31 Dec 2022 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 27 Oct 2022 (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 purpose of this study is assess the efficacy of ASIMOMMY® in increasing breast milk production in postpartum mothers.
Detailed description
Several traditional herbs have been used and is well known since a long time ago by Indonesian people to increase the production of breastmilk, such as Katuk leaves (Sauropus androgynous Folium), Fenugreek (Trigonella foenum-graceum), and Moringa leaves (Moringa oleifera Folium). These plants have been scientifically proven through preclinical and even clinical research. However, not many have been further developed as phytopharmaceuticals that can be used in formal health services.
In previous research, ASI MOMMY® capsules have been successfully produced in accordance to the traditional method of making good herbal drugs, with each capsule containing extracts of Katuk leaf (300 mg), Fenugreek (150 mg), and Moringa leaf (50 mg). This formulation has gone through pharmacodynamic activity test, and acute and subactute toxicity test. Research has shown that ASI MOMMY® is works actively as a galactogogue and is not toxic, therefore it is safe to be given to humans (unpublished),
No research has been done to test the benefits of ASI MOMMY® in increasinng breastmilk production. Therefore, this research is a clinical trial that intends to see the benefits of ASI MOMMY® for increasing breastmilk production in postpartum women. This research is a part of the previous main research that is still ongoing to this day which aims to develop the formulation of ASI MOMMY® as a phytopharmaceutical
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASIMOMMY® | Experimental | Drug: ASIMOMMY®Experimental: 2 capsules of ASIMOMMY, orally one times daily from days 1 to 7 |
| Domperidone | Active comparator | Drug: DomperidonDomperidone capsule, one capsule, orally three times daily from days 1 to 7 |
| Placebo | Placebo comparator | Drug: PlaceboIdentical 2 capsules of placeb, orally one times daily from days 1 to 7 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Mothers 20-35 years old.
- Gestational age at delivery 37-40 weeks.
- Vaginal delivery.
- Normal body mass index (BMI 18.5-24.9 kg/m2).
- Not taking drugs or breast milk enhancement supplements.
Key exclusion criteria (8 listed)
- Allergy to ASI MOMMY® and Domperidon.
- The mother is taking medications that affect the effects of domperidone (such as antacids, cimetidine, ranitidine, famotidine and nizatidine) or medications that interact with domperidone (such as haloperidol, lithium).
- The mother is in a state of illness requiring hospitalization.
- Mother has HIV AIDS, heart problems, mastitis, and had undergone breast surgery.
- Underweight, overweight and obese mothers.
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 |
|---|---|---|
| ASIMOMMY®ASIMOMMY 500 mg | Drug | ASIMOMMY® |
| DomperidonDomperidone capsule 10 mg | Drug | Domperidone |
| PlaceboCapsules of placebo 500mg. | Drug | Placebo |
Primary outcome
Increase in Neonates Weight
Time frame: Day 0 to day 7
The primary outcome is the difference in the neonates weight after 7 days of treatment with ASIMOMMY® compared to mothers receiving domperidone and placebo (mean day 7 neonates weight minus mean day 0 neonates weight).
2 secondary outcomes
Proportion of non serious adverse event within 7 days
Time frame: Day 0 to day 7
Proportion of serious adverse event within 7 days
Time frame: Day 0 to day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASIMOMMY® and Domperidon in people with Breastfeeding Mothers, run by Gadjah Mada University at 1 site in Indonesia.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 29 Mar 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 Indonesia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Neonates Weight (time frame: Day 0 to day 7). 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 29 Mar 2023.