Supplementation of Galatonol 300 mg / Striatin 30 mg in Postpartum Lactating Mothers

Dexa Medica

Status and phase: Enrolling; Phase 3

Conditions: Lactation Induced

Treatments: Drug: Galatonol 300 mg/Striatin 30 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06558071

ASM-0120

Details and patient eligibility

About

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.

Full 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).

Enrollment: 160 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Investigational Group

Experimental group

Description:

1 film-coated caplet (Galatonol 300 mg/Striatin 30 mg), twice daily, after morning and evening meals

Treatment:

Drug: Galatonol 300 mg/Striatin 30 mg

Control Group

Placebo Comparator group

Description:

1 film-coated caplet of Placebo, twice daily, after morning and evening meals

Treatment:

Drug: Placebo