Lactation InducedPhase 3NCT06558071
Supplementation of Galatonol 300 mg / Striatin 30 mg in Postpartum Lactating Mothers
A Phase 3 study testing Galatonol 300 mg/Striatin 30 mg in people with Lactation Induced, run by Dexa Medica Group at 10 sites in Indonesia.
Trial summary
This is a randomized, double-blind, and placebo-controlled study involving mothers as the participant and participant's babies evaluating the effect of a 15-day-supplementation with a product containing extracts derived from a combination of herbal plants (katuk \& torbangun leaves) and snakehead fish in stimulating… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation Induced
- What is being tested?
- Galatonol 300 mg/Striatin 30 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 10 sitesIndonesia
- Study dates
- 21 Oct 2024to 27 May 2025
- Phase
- Phase 3
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent prior to participation in the study.
- Generally healthy women aged >= 18-35 years.
- Having a full-term gestational age (37- 40 weeks, inclusive).
- The infant to breastfed: having normal birth body weight (2500-4000 gr).
- Giving consent and commitment to pursue an exclusive breastfeeding
- Willing to comply with the study protocol.
- Spontaneous delivery.
- Healthy newborn baby
Who cannot join
- Difficult breastfeeding due to organic defect;
- Suspected COVID-19 by clinical symptoms.
- LATCH Score < 4;
- Choosing not to breastfeed due to other subjective or objective reasons;
- Having multiple birth;
- Known major medical complications during delivery;
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- Known to have breast diseases, such as: mastitis, or malignancies
- Breastfeeding prohibited due to clindamycin injection within the past week.
- History of smoking, alcohol drinking, or any drug abuse
- Known to have any relevant chronic infections or illness and gestational diabetes;
- Known to have disorders of major organs ;
- Taking any medication or supplementation known to have galactagogue properties within the last trimester of pregnancy;
- Taking any non-pharmacological complementary treatment within the last trimester of pregnancy aiming to affect breast milk production.
- Participation in any other interventional clinical studies within 30 days prior to Screening.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Indonesia10 sites
Klinik Pratama Anugrah Sleman
Sleman, Special Region of Yogyakarta
Private Midwife Practice (Bidan Anisa)
Sleman, Special Region of Yogyakarta
Private Midwife Practice (Bidan Catur)
Sleman, Special Region of Yogyakarta
Private Midwife Practice (Bidan Istri Utami)
Sleman, Special Region of Yogyakarta
Private Midwife Practice (Bidan Istri Yuliani)
Sleman, Special Region of Yogyakarta
Private Midwife Practice (Bidan Kisti)
Sleman, Special Region of Yogyakarta
Private Midwife Practice (Bidan Mei)
Sleman, Special Region of Yogyakarta
Private Midwife Practice (Bidan Tutik)
Sleman, Special Region of Yogyakarta
Private Midwife Practice (Bidan Wati)
Sleman, Special Region of Yogyakarta
Private Midwife Practice (Bidan Widya)
Sleman, Special Region of Yogyakarta
About this study
Official title: Supplementation of Galatonol 300 mg / Striatin 30 mg Combined Bioactive Fraction in Postpartum Lactating Mothers
This is a randomized, double-blind, and placebo-controlled study involving mothers as the participant and participant's babies evaluating the effect of a 15-day-supplementation with a product containing extracts derived from a combination of herbal plants (katuk \& torbangun leaves) and snakehead fish in stimulating breast milk production.
Read the detailed description
The study product is a herbal product containing 300 mg Galatonol bioactive fraction, enriched with 30 mg Striatin bioactive fraction. This lactation supplement has been granted the marketing authorization from Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM RI) as traditional medicine with the indication to enhance breast milk production.
A total of 160 subjects (80 subjects in each group) who have just partus, are planned to participate in this study. Eligible subjects will be allocated in a random and blinded fashion to receive one of the two products (study product or placebo) and to come for follow-up visits at Day 4, 8 and 15 (End of Study).
- Conditions
- Lactation Induced
- Being tested
- Galatonol 300 mg/Striatin 30 mg, Placebo
- Keywords
- Lactating mothers, Galactagogues, Galatonol /Striatin Bioactive Fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galatonol 300 mg/Striatin 30 mgDrug
Also called Herba Asimor
1 film-coated caplet of Herba Asimor, twice daily
PlaceboDrug
1 film-coated caplet of placebo Herba Asimor, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Investigational Group | Experimental | 1 film-coated caplet (Galatonol 300 mg/Striatin 30 mg), twice daily, after morning and evening meals Receives: Drug: Galatonol 300 mg/Striatin 30 mg |
| Control Group | Placebo comparator | 1 film-coated caplet of Placebo, twice daily, after morning and evening meals Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant weight
The sufficient breastmilk supply indicated by infant weight at Day 15 of treatment (i.e. 14 days after study treatment initation) relative to Baseline (infant weight at 24 Hour post-partum).
Measured: Day 15
Secondary outcomes (6)
Infant weight
Infant weight at Day 8 of treatment (i.e. 7 days after study treatment initation) relative to Baseline.
Measured: Day 8
Breastmilk production
Breastmilk production at Day 8 and Day 15 of treatment (i.e. 7, and 14 days after study treatment initiation) as represented by three-hourly breast milk volume.
Measured: Day 8, Day 15
Breastfeeding frequency
Mean breastfeeding frequency per 24 hours up to Day 8 and Day 15 of treatment (i.e. 7 and 14 days after study treatment initiation, respectively)
Measured: Day 8, Day 15
Prolactin level
Maternal prolactin level at Day 8 and 15 of treatment
Measured: Day 8, Day 15
Oxytocin level
Maternal oxytocin level at Day 8 and 15 of treatment
Measured: Day 8, Day 15
Frequency of infant void and stool
Mean daily frequency of infant void and stool up to Day 8 and 15 of treatment
Measured: Day 8, Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start21 Oct 2024
- Primary completion20 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactation InducedStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fenny Yunita, MD, MSi, PhD, Principal investigator, Faculty of Medicine, Universitas Tarumanagara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558071
- Sponsor's protocol ID
- ASM-0120
- Status last verified
- Feb 2026
- First submitted
- 14 Aug 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Galatonol 300 mg / Striatin 30 mg Combined Bioactive Fraction in Postpartum Lactating Mothers
- ClinicalTrials.gov ID
- NCT06558071
- Acronym / sponsor ID
- ASM-0120
- Conditions
- Lactation Induced
- Keywords
- Lactating mothers, Galactagogues, Galatonol /Striatin Bioactive Fraction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 16 Aug 2024 (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.
This is a randomized, double-blind, and placebo-controlled study involving mothers as the participant and participant's babies evaluating the effect of a 15-day-supplementation with a product containing extracts derived from a combination of herbal plants (katuk \& torbangun leaves) and snakehead fish in stimulating breast milk production.
Detailed description
The study product is a herbal product containing 300 mg Galatonol bioactive fraction, enriched with 30 mg Striatin bioactive fraction. This lactation supplement has been granted the marketing authorization from Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM RI) as traditional medicine with the indication to enhance breast milk production.
A total of 160 subjects (80 subjects in each group) who have just partus, are planned to participate in this study. Eligible subjects will be allocated in a random and blinded fashion to receive one of the two products (study product or placebo) and to come for follow-up visits at Day 4, 8 and 15 (End of Study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Group | Experimental | Drug: Galatonol 300 mg/Striatin 30 mg1 film-coated caplet (Galatonol 300 mg/Striatin 30 mg), twice daily, after morning and evening meals |
| Control Group | Placebo comparator | Drug: Placebo1 film-coated caplet of Placebo, twice daily, after morning and evening meals |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent prior to participation in the study.
- Generally healthy women aged >= 18-35 years.
- Having a full-term gestational age (37- 40 weeks, inclusive).
- The infant to breastfed: having normal birth body weight (2500-4000 gr).
- Giving consent and commitment to pursue an exclusive breastfeeding
Key exclusion criteria (14 listed)
- Difficult breastfeeding due to organic defect;
- Suspected COVID-19 by clinical symptoms.
- LATCH Score < 4;
- Choosing not to breastfeed due to other subjective or objective reasons;
- Having multiple birth;
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 |
|---|---|---|
| Galatonol 300 mg/Striatin 30 mgAlso: Herba Asimor1 film-coated caplet of Herba Asimor, twice daily | Drug | Investigational Group |
| Placebo1 film-coated caplet of placebo Herba Asimor, twice daily | Drug | Control Group |
Primary outcome
Infant weight
Time frame: Day 15
The sufficient breastmilk supply indicated by infant weight at Day 15 of treatment (i.e. 14 days after study treatment initation) relative to Baseline (infant weight at 24 Hour post-partum).
6 secondary outcomes
Infant weight
Time frame: Day 8
Breastmilk production
Time frame: Day 8, Day 15
Breastfeeding frequency
Time frame: Day 8, Day 15
Prolactin level
Time frame: Day 8, Day 15
Oxytocin level
Time frame: Day 8, Day 15
Frequency of infant void and stool
Time frame: Day 8, Day 15
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 17 Feb 2026.
Related trials for Lactation Induced
RecruitingObservational study
Birth & Breastfeeding Support Study
Breastfeeding, Breastfeeding Initiation
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.
Fenny Yunita, MD, MSi, PhD principal investigator
Faculty of Medicine, Universitas Tarumanagara
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Galatonol 300 mg/Striatin 30 mg in people with Lactation Induced, run by Dexa Medica Group at 10 sites 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 14 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Infant weight (time frame: Day 15). 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 17 Feb 2026.