Postpartum Depression (PPD)NCT07337512
Moringa Oleifera and Phoenix Dactylifera L. Effects on Cortisol and Breast Milk in Postpartum Depression
A study testing Phoenix dactylifera L and Moringa oleifera in people with Postpartum Depression (PPD), run by Melania Asi at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression (PPD)
- What is being tested?
- Phoenix dactylifera L and Moringa oleifera
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 363 participants
- Where
- 1 siteIndonesia
- Study dates
- 19 May 2024to 19 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
Poltekkes Kemenkes Kendari
Kendari, Southeast Sulawesi, 93231
About this study
Official title: Moringa Oleifera and Phoenix Dactylifera L. Effects on Cortisol and Breast Milk in Postpartum Depression: A Randomized Controlled Trial
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)
- Being tested
- Phoenix dactylifera L, Moringa oleifera, Placebo: consumed food three times a day
- Keywords
- Moringa oleifera Leaf, Phoenix dactylifera L, Salivary Cortisol, Breast Milk, Postpartum Mother, Depression
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phoenix dactylifera LDrug
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 oleiferaDrug
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 dayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 | Active comparator | 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. Receives: Drug: Phoenix dactylifera L; Drug: Moringa oleifera; Other: Placebo: consumed food three times a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Depression Levels of Breastfeeding Mothers (Based on BDI Scores), cortisol levels and breast milk production in each group
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):
- Depression: Beck Depression Inventory (BDI) score, interval scale (unit: BDI score), measured at Week 0 and Week 4.
- Salivary cortisol level: Salivary cortisol concentration (unit: μg/dL), measured at Week 0 and Week 4.
- Breast milk production: Breast milk volume (unit: mL), measured at Week 0 and Week 4.
Measured: before the intervention and after 28 days of intervention. Assessments took place in week 1 (week 0) and week 4 (after 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start19 May 2024
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melania Asi
- Sponsor type
- University, hospital or other
- Collaborators
- Indonesia-MoH
- Responsible party
- Sponsor-investigator, Melania Asi, Health Polytechnic, Ministry of Health, Kendari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337512
- Sponsor's protocol ID
- DP.04.03/F.XXXVI.15/010/2024
- Other IDs
- 7011.PKPT.001.43321
- Status last verified
- Jan 2026
- First submitted
- 6 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data was not provided to other researchers or outside this study because it is prohibited to share it according to the ethical approval from Poltekkes Kemenkes Kendari with number No.DP.04.03/F.XXXVI.15/004/2024 on May 6.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moringa Oleifera and Phoenix Dactylifera L. Effects on Cortisol and Breast Milk in Postpartum Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07337512
- Acronym / sponsor ID
- DP.04.03/F.XXXVI.15/010/2024
- Conditions
- Postpartum Depression (PPD)
- Keywords
- Moringa oleifera Leaf, Phoenix dactylifera L, Salivary Cortisol, Breast Milk, Postpartum Mother, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Melania AsiUniversity, hospital or other
- Collaborators
- Indonesia-MoH
- Study start
- 19 May 2024 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 | Active comparator | Drug: Phoenix dactylifera L, Drug: Moringa oleifera, Other: Placebo: consumed food three times a dayThis 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phoenix dactylifera LThe 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. | Drug | 3 |
| Moringa oleiferaMoringa 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 | Drug | 3 |
| Placebo: consumed food three times a dayconsumed 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. | Other | 3 |
Primary outcome
Changes in Depression Levels of Breastfeeding Mothers (Based on BDI Scores), cortisol levels and breast milk production in each group
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No. IPD data was not provided to other researchers or outside this study because it is prohibited to share it according to the ethical approval from Poltekkes Kemenkes Kendari with number No.DP.04.03/F.XXXVI.15/004/2024 on May 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phoenix dactylifera L and Moringa oleifera in people with Postpartum Depression (PPD), run by Melania Asi at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Depression Levels of Breastfeeding Mothers (Based on BDI Scores), cortisol levels and breast milk production in each group (time frame: before the intervention and after 28 days of intervention. Assessments took place in week 1 (week 0) and week 4 (after 28 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.