Moringa Oleifera and Phoenix Dactylifera L. Effects on Cortisol and Breast Milk in Postpartum Depression: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Melania Asi
- 入组人数
- 363
- 试验地点
- 1
- 主要终点
- Changes in Depression Levels of Breastfeeding Mothers (Based on BDI Scores), cortisol levels and breast milk production in each group
概览
简要总结
Postpartum depression affects 10-20% of new mothers globally, potentially disrupting breast milk production. This study aimed to provide valuable insights into effective interventions to improve the health and well-being of Postpartum Mothers with depression. This study used a randomized controlled trial design with three groups: intervention 1 (dates), intervention 2 (Moringa oleifera), and a control group. A total of 363 postpartum mothers participated, and data were collected through salivary cortisol levels (ELISA) and Beck Depression Inventory (BDI) scores to measure depression levels and breast milk production (ACIS AC-15X digital scale and Crown electric breast pump) before and after the intervention for 28 days. Data analysis was performed using paired sample t-test and the independent t-test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Eligibility Criteria:
- •Inclusion Criteria:
- •Individuals aged 18-35 years
- •Mothers with infants aged 2 weeks to 6 months
- •Body Mass Index (BMI) greater than 18.7
- •Scores on the Beck Depression Inventory (BDI) ranging from mild to severe depression
- •Breast milk production of less than 300 g/day
排除标准
- •Mothers with endocrine disorders
- •Acute or chronic diseases
- •Conditions such as hypoplastic breast tissue
- •Use of combined estrogen contraceptives
- •Mothers who smoke or consume alcohol
研究组 & 干预措施
3
This study employed a three-arm design over 28 days comparing two active interventions against placebo control. The Phoenix dactylifera L. group received 120g daily dates (40g portions thrice daily) using food-grade certified products with precise digital scaling (±0.1g accuracy) and controlled storage in airtight containers with humidity regulation. The Moringa oleifera group received pharmaceutical-grade capsules at 1000mg daily (500mg twice daily) with analytical balance verification (±0.1mg) and amber glass storage for light protection. The placebo group maintained regular three-daily meals without additional intervention. Both active groups utilized standardized measurement protocols, quality-certified materials, and comprehensive documentation systems including food diaries and visual monitoring to ensure intervention fidelity and participant compliance throughout the study period.
干预措施: Phoenix dactylifera L (Drug)
3
This study employed a three-arm design over 28 days comparing two active interventions against placebo control. The Phoenix dactylifera L. group received 120g daily dates (40g portions thrice daily) using food-grade certified products with precise digital scaling (±0.1g accuracy) and controlled storage in airtight containers with humidity regulation. The Moringa oleifera group received pharmaceutical-grade capsules at 1000mg daily (500mg twice daily) with analytical balance verification (±0.1mg) and amber glass storage for light protection. The placebo group maintained regular three-daily meals without additional intervention. Both active groups utilized standardized measurement protocols, quality-certified materials, and comprehensive documentation systems including food diaries and visual monitoring to ensure intervention fidelity and participant compliance throughout the study period.
干预措施: Moringa oleifera (Drug)
结局指标
主要结局
Changes in Depression Levels of Breastfeeding Mothers (Based on BDI Scores), cortisol levels and breast milk production in each group
时间窗: before the intervention and after 28 days of intervention. Assessments took place in week 1 (week 0) and week 4 (after 28 days).
This study has more than one outcome measure with different units of measurement, so each variable should be expressed as a separate outcome measure and not combined unless a composite formula is defined. To clarify reporting, the Outcome Measures are revised as follows. Evaluation time points (for all outcomes): Week 0 (pre-intervention) and Week 4 (day 28 post-intervention). Primary/secondary outcomes (reported separately): 1. Depression: Beck Depression Inventory (BDI) score, interval scale (unit: BDI score), measured at Week 0 and Week 4. 2. Salivary cortisol level: Salivary cortisol concentration (unit: μg/dL), measured at Week 0 and Week 4. 3. Breast milk production: Breast milk volume (unit: mL), measured at Week 0 and Week 4.
次要结局
未报告次要终点
研究者
Melania Asi
Director
Health Polytechnic, Ministry of Health, Kendari