Efficacy of ASIMOMMY® Compared to Domperidone and Placebo in Increasing Breastfeeding: Randomized Single-Blind Controlled Trial in Indonesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Increase in Neonates Weight
研究概览
简要总结
The purpose of this study is assess the efficacy of ASIMOMMY® in increasing breast milk production in postpartum mothers.
详细描述
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shown that ASI MOMMY® is works actively as a galactogogue and is not toxic, therefore it is safe to be given to humans (unpublished),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
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
ASIMOMMY®
Experimental:
2 capsules of ASIMOMMY, orally one times daily from days 1 to 7
干预措施: ASIMOMMY® (Drug)
Domperidone
Domperidone capsule, one capsule, orally three times daily from days 1 to 7
干预措施: Domperidon (Drug)
Placebo
Identical 2 capsules of placeb, orally one times daily from days 1 to 7
干预措施: Placebo (Drug)
结局指标
主要结局
Increase in Neonates Weight
时间窗: 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).
次要结局
- Proportion of non serious adverse event within 7 days(Day 0 to day 7)
- Proportion of serious adverse event within 7 days(Day 0 to day 7)
研究者
Andini Juwan Prabandari, MD
MD
Gadjah Mada University