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

NCT ID: NCT07337512

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 363 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-19
• Study Completion Date: 2024-11-19

Brief Summary

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.

Conditions

Postpartum Depression (PPD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Phoenix dactylifera L

Intervention Type: DRUG

The intervention method in this study used Phoenix dactylifera L. (dates) as the main ingredient with a standardized dose of 120 grams per day per participant, divided into three 40-gram portions over a 28-day period. The dates used were food-grade with a Certificate of Analysis (CoA) certification from a trusted supplier to ensure quality and safety of consumption. Measurement instrumentation included a digital scale with an accuracy of ±0.1 grams for daily portions, an analytical balance for high-precision measurements, and a measuring cup to ensure portion consistency. The storage and distribution system was designed using food-grade airtight containers, individual plastic bags, a cooler box for transportation, and silica gel packets for humidity control, equipped with a waterproof labeling system. Documentation and monitoring were carried out using a food diary form, a 28-day intervention calendar, and a digital camera for visual documentation.

Moringa oleifera

Intervention Type: DRUG

Moringa oleifera: The intervention method in this study used Moringa oleifera capsules as the primary therapeutic agent at a standard dose of 1000 mg per day per participant, administered in two divided doses of 500 mg each (morning and evening) for a 28-day period. The Moringa oleifera capsules used were pharmaceutical-grade capsules with appropriate quality certification from a verified supplier to ensure purity and safety for human consumption. Measurement instruments included a precision analytical balance with an accuracy of ±0.1 mg for capsule weight verification, an automatic capsule counter for dose consistency, and a calibrated measuring device to ensure uniform distribution. The storage and distribution system was implemented using pharmaceutical-grade amber glass containers to protect from light degradation, individual blister packs for daily doses, temperature-controlled storage units, and desiccant packs for humidity control, equipped with a labeling system that indicated

Placebo: consumed food three times a day

Intervention Type: OTHER

consumed food three times a day: Participants received no additional intervention and only consumed food three times a day for 28 days, serving as a baseline to compare the effects of the intervention.

Interventions

Phoenix dactylifera L

The intervention method in this study used Phoenix dactylifera L. (dates) as the main ingredient with a standardized dose of 120 grams per day per participant, divided into three 40-gram portions over a 28-day period. The dates used were food-grade with a Certificate of Analysis (CoA) certification from a trusted supplier to ensure quality and safety of consumption. Measurement instrumentation included a digital scale with an accuracy of ±0.1 grams for daily portions, an analytical balance for high-precision measurements, and a measuring cup to ensure portion consistency. The storage and distribution system was designed using food-grade airtight containers, individual plastic bags, a cooler box for transportation, and silica gel packets for humidity control, equipped with a waterproof labeling system. Documentation and monitoring were carried out using a food diary form, a 28-day intervention calendar, and a digital camera for visual documentation.

Intervention Type: DRUG

Moringa oleifera

Moringa oleifera: The intervention method in this study used Moringa oleifera capsules as the primary therapeutic agent at a standard dose of 1000 mg per day per participant, administered in two divided doses of 500 mg each (morning and evening) for a 28-day period. The Moringa oleifera capsules used were pharmaceutical-grade capsules with appropriate quality certification from a verified supplier to ensure purity and safety for human consumption. Measurement instruments included a precision analytical balance with an accuracy of ±0.1 mg for capsule weight verification, an automatic capsule counter for dose consistency, and a calibrated measuring device to ensure uniform distribution. The storage and distribution system was implemented using pharmaceutical-grade amber glass containers to protect from light degradation, individual blister packs for daily doses, temperature-controlled storage units, and desiccant packs for humidity control, equipped with a labeling system that indicated

Intervention Type: DRUG

Placebo: consumed food three times a day

consumed food three times a day: Participants received no additional intervention and only consumed food three times a day for 28 days, serving as a baseline to compare the effects of the intervention.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia-MoH

OTHER_GOV

Sponsor Role: collaborator

Melania Asi

OTHER

Sponsor Role: lead

Responsible Party

Melania Asi

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Poltekkes Kemenkes Kendari

Kendari, Southeast Sulawesi, Indonesia

Countries

Indonesia

Other Identifiers

7011.PKPT.001.43321

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

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

Identifier Type: -

Identifier Source: org_study_id