Clinical trial NCT06558071: Supplementation of Galatonol 300 mg / Striatin 30 mg in Postpartum Lactating Mothers
Official title: Supplementation of Galatonol 300 mg / Striatin 30 mg Combined Bioactive Fraction in Postpartum Lactating Mothers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lactation Induced
Keywords: Lactating mothers
Galactagogues
Galatonol /Striatin Bioactive Fraction
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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).

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent prior to participation in the study.
2. Generally healthy women aged \>= 18-35 years.
3. Having a full-term gestational age (37- 40 weeks, inclusive).
4. The infant to breastfed: having normal birth body weight (2500-4000 gr).
5. Giving consent and commitment to pursue an exclusive breastfeeding
6. Willing to comply with the study protocol.
7. Spontaneous delivery.
8. Healthy newborn baby

Exclusion Criteria:

1. Difficult breastfeeding due to organic defect;
2. Suspected COVID-19 by clinical symptoms.
3. LATCH Score \< 4;
4. Choosing not to breastfeed due to other subjective or objective reasons;
5. Having multiple birth;
6. Known major medical complications during delivery;
7. Known to have breast diseases, such as: mastitis, or malignancies
8. Breastfeeding prohibited due to clindamycin injection within the past week.
9. History of smoking, alcohol drinking, or any drug abuse
10. Known to have any relevant chronic infections or illness and gestational diabetes;
11. Known to have disorders of major organs ;
12. Taking any medication or supplementation known to have galactagogue properties within the last trimester of pregnancy;
13. Taking any non-pharmacological complementary treatment within the last trimester of pregnancy aiming to affect breast milk production.
14. Participation in any other interventional clinical studies within 30 days prior to Screening.

Primary outcomes:
measure: Infant weight
timeFrame: Day 15
Secondary outcomes:
measure: Infant weight
timeFrame: Day 8
measure: Breastmilk production
timeFrame: Day 8, Day 15
measure: Breastfeeding frequency
timeFrame: Day 8, Day 15
measure: Prolactin level
timeFrame: Day 8, Day 15
measure: Oxytocin level
timeFrame: Day 8, Day 15
measure: Frequency of infant void and stool
timeFrame: Day 8, Day 15
Other outcomes:
measure: Infant's daily duration of sleeping
timeFrame: Day 8, Day 15
measure: Qualitative self-assessment of breast-milk thicknes
timeFrame: Day 8, Day 15
measure: Body temperature
timeFrame: Day 8, Day 15
measure: Blood pressure
timeFrame: Day 8, Day 15
measure: Heart rate and respiratory rate
timeFrame: Day 8, Day 15
measure: Random plasma glucose
timeFrame: Day 8, Day 15
measure: Liver function
timeFrame: Day 15
measure: Renal function
timeFrame: Day 15
measure: Complete blood count
timeFrame: Day 15
measure: Adverse events
timeFrame: Day 3, Day 8, Day 15
Locations:
city: Sleman
country: Indonesia
facility: Klinik Pratama Anugrah Sleman
state: Daerah Istimewa Yogyakarta
city: Sleman
country: Indonesia
facility: Private Midwife Practice (Bidan Anisa)
state: Daerah Istimewa Yogyakarta
city: Sleman
country: Indonesia
facility: Private Midwife Practice (Bidan Catur)
state: Daerah Istimewa Yogyakarta
city: Sleman
country: Indonesia
facility: Private Midwife Practice (Bidan Istri Utami)
state: Daerah Istimewa Yogyakarta
city: Sleman
country: Indonesia
facility: Private Midwife Practice (Bidan Istri Yuliani)
state: Daerah Istimewa Yogyakarta
city: Sleman
country: Indonesia
facility: Private Midwife Practice (Bidan Kisti)
state: Daerah Istimewa Yogyakarta
city: Sleman
country: Indonesia
facility: Private Midwife Practice (Bidan Mei)
state: Daerah Istimewa Yogyakarta
city: Sleman
country: Indonesia
facility: Private Midwife Practice (Bidan Tutik)
state: Daerah Istimewa Yogyakarta
city: Sleman
country: Indonesia
facility: Private Midwife Practice (Bidan Wati)
state: Daerah Istimewa Yogyakarta
city: Sleman
country: Indonesia
facility: Private Midwife Practice (Bidan Widya)
state: Daerah Istimewa Yogyakarta
Study officials:
affiliation: Faculty of Medicine, Universitas Tarumanagara
name: Fenny Yunita, MD, MSi, PhD
role: PRINCIPAL_INVESTIGATOR
References: