NCT05880589招募中不适用
Efficacy and Safety of Milk Secretory Supplement Containing Fenugreek, Banana Flower, and Ginger Extract in Breast-feeding Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Amount of breast milk
研究概览
简要总结
The objective of this study are to evaluate efficacy and safety of milk secretory supplement containing fenugreek, banana flower, and ginger extract in breast-feeding volunteers
详细描述
There are 24 volunteers in this study. They are randomly divided into 2 groups which are milk secretory supplement group and placebo group. The volunteers take 2 tablets of the sample 2 times/day for 14 days. Amount of breast milk, calcium, iron, docosahexaenoic acid, quality of life, adverse reaction, and satisfaction before taking and after taking for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •During lactation
- •Using only breast pump
- •No taking medicine or dietary that has an effect on milk secretary including domperidone, banana flower, fenugreek, and ginger in 48 hours
- •No smoking and alcohol drinking
- •Can read and write in Thai language
- •Can meet researcher at the date of appointment
- •No complication after delivering
排除标准
- •Have uncontrolled diseases, cancer, or heart disease
- •Have immunocompromised disease or use steroid in 2 weeks
- •Allergic to fenugreek, banana flower, ginger, docosahexaenoic acid, iron, folate, and iodine
- •Cannot follow the protocol
结局指标
主要结局
Amount of breast milk
时间窗: 14 days
Measure volume of breast milk (ml) (High volume means high efficacy)
次要结局
- Quality of life of volunteers(14 days)
- Iron in milk(14 days)
- Calcium in milk(14 days)
- Docosahexaenoic acid in milk(14 days)
- Skin reaction after taking supplement(14 days)
- Satisfaction after taking supplement(14 days)
- Respiratory tract reaction after taking supplement(14 days)
- Gastrointestinal reaction after taking supplement(14 days)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose ResponseHealthyAdultAsianPreDiabetesNCT05570435Société des Produits Nestlé (SPN)31
已完成
不适用
Fortified Skimmed Mother's Milk in the Management of ChylothoraxChylous Pleural Effusion Following Cardiothoracic SurgeryNCT01673165Oregon Health and Science University17
已完成
不适用
Effect of Sublimated Mare Milk Supplement on Gut Microbiome in Psoriasis PatientsPsoriasisNCT03594877Nazarbayev University Medical Center40
已完成
不适用
Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel SyndromeIrritable Bowel SyndromeIrritable Bowel Syndrome With ConstipationIrritable Bowel Syndrome MixedIrritable Bowel Syndrome With DiarrheaNCT04484467Federal Stare Budgetary Scientific Institution, Mental Health Research Center56
已完成
1 期
Clinical Safety of a Novel Milk Protein PeptideDrug SafetyNCT01412658Ambryx Biotechnology73