Moringa Oleifera and Phoenix Dactylifera L. Effects on Cortisol and Breast Milk in Postpartum Depression

Melania Asi

Status: Completed

Conditions: Postpartum Depression (PPD)

Treatments: Drug: Moringa oleifera; Drug: Phoenix dactylifera L; Other: Placebo: consumed food three times a day

Study type: Interventional

Funder types: Other

Identifiers

NCT07337512

DP.04.03/F.XXXVI.15/010/2024

7011.PKPT.001.43321 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 363 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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363 participants in 1 patient group

3

Active Comparator group

Description:

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.

Treatment:

Other: Placebo: consumed food three times a day

Drug: Phoenix dactylifera L

Drug: Moringa oleifera