Supplementation of Galatonol 300 mg / Striatin 30 mg Combined Bioactive Fraction in Postpartum Lactating Mothers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 10
- 主要终点
- Infant weight
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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;
- •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.
研究组 & 干预措施
Investigational Group
1 film-coated caplet (Galatonol 300 mg/Striatin 30 mg), twice daily, after morning and evening meals
干预措施: Galatonol 300 mg/Striatin 30 mg (Drug)
Control Group
1 film-coated caplet of Placebo, twice daily, after morning and evening meals
干预措施: Placebo (Drug)
结局指标
主要结局
Infant weight
时间窗: 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).
次要结局
- Breastfeeding frequency(Day 8, Day 15)
- Breastmilk production(Day 8, Day 15)
- Frequency of infant void and stool(Day 8, Day 15)
- Infant weight(Day 8)
- Prolactin level(Day 8, Day 15)
- Oxytocin level(Day 8, Day 15)