Anemia of PregnancyPhase 3NCT05737862
Effect of Moringa Oleifera Leaf on Hemoglobin Levels in Anemia
A Phase 3 study testing Moringa oleifera capsules and iron and folic acid supplements in people with Anemia of Pregnancy, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
The main objective of this study was to compare the results of hemoglobin levels between pregnant women in the treatment group and the control group. Participants will be subjected to anthropometric measurements, recall of food intake for 1 x 24 hours, check hemoglobin before and after being given the intervention and… Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia of Pregnancy
- What is being tested?
- Moringa oleifera capsules and iron and folic acid supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2022to 30 Jul 2022
- Phase
- Phase 3
- 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 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women with 2nd and 3rd trimester of pregnancy
- Pregnant women with mild to moderate anemia At day 90 after treatment
Who cannot join
- Hypotensive pregnant women
- Pregnant women with Gemelli
- Pregnant women with chronic diseases (hepatitis and HIV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Moringa Oleifera Leaf Capsul on Hemoglobin Levels in Anemia: A Pilot Study
The main objective of this study was to compare the results of hemoglobin levels between pregnant women in the treatment group and the control group. Participants will be subjected to anthropometric measurements, recall of food intake for 1 x 24 hours, check hemoglobin before and after being given the intervention and participants in the treatment group are given moringa leaf capsules and iron tablets while participants in the control group are only given iron tablets. Researchers will compare the final results of hemoglobin levels between the treatment group and the control group
- Conditions
- Anemia of Pregnancy
- Being tested
- Moringa oleifera capsules, iron and folic acid supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa oleifera capsulesDietary supplement
In this arm, pregnant mothers receive capsules containing 500 mg of powdered Moringa oleifera leaves which contain 13.09 mg of iron per100 gram. Dose: 2 × 2 capsules per day for 30 days
iron and folic acid supplementsDietary supplement
In this arm, pregnant mothers receive IFA tablets 2 × 1 tablet a day for 30 days. Each IFA tablet contains 400 mcg folic acid and 180 mg Ferrous Fumarate.
| Study group | Role | What they receive |
|---|---|---|
| Moringa oleifera leaf capsule | Experimental | Subjects in this arm receive experimental capsules containing powdered Moringa oleifera leaf capsules along with IFA tablets Receives: Dietary Supplement: Moringa oleifera capsules; Dietary Supplement: iron and folic acid supplements |
| Iron and folic acid capsule | Active comparator | Subjects in this arm only receive iron and folic acid (IFA) tablets Receives: Dietary Supplement: iron and folic acid supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Haemoglobin (Hb) level
Hb will be meassured twice, before treatment and 30 days after treatment
Measured: Day 0 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Apr 2022
- Primary completion30 Jun 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of PregnancyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 group receives capsules of powdered Moringa leaves (active comparator), and the other group receives IFA tablets as part of routine clinical care.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737862
- Sponsor's protocol ID
- MAGPH-202210.01
- Status last verified
- Mar 2023
- First submitted
- 10 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moringa Oleifera Leaf Capsul on Hemoglobin Levels in Anemia: A Pilot Study
- ClinicalTrials.gov ID
- NCT05737862
- Acronym / sponsor ID
- MAGPH-202210.01
- Conditions
- Anemia of Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 21 Feb 2023 (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.
The main objective of this study was to compare the results of hemoglobin levels between pregnant women in the treatment group and the control group. Participants will be subjected to anthropometric measurements, recall of food intake for 1 x 24 hours, check hemoglobin before and after being given the intervention and participants in the treatment group are given moringa leaf capsules and iron tablets while participants in the control group are only given iron tablets. Researchers will compare the final results of hemoglobin levels between the treatment group and the control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 1 group receives capsules of powdered Moringa leaves (active comparator), and the other group receives IFA tablets as part of routine clinical care.
| Arm | Type | Receives |
|---|---|---|
| Moringa oleifera leaf capsule | Experimental | Dietary Supplement: Moringa oleifera capsules, Dietary Supplement: iron and folic acid supplementsSubjects in this arm receive experimental capsules containing powdered Moringa oleifera leaf capsules along with IFA tablets |
| Iron and folic acid capsule | Active comparator | Dietary Supplement: iron and folic acid supplementsSubjects in this arm only receive iron and folic acid (IFA) tablets |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pregnant women with 2nd and 3rd trimester of pregnancy
- Pregnant women with mild to moderate anemia At day 90 after treatment
Key exclusion criteria (3 listed)
- Hypotensive pregnant women
- Pregnant women with Gemelli
- Pregnant women with chronic diseases (hepatitis and HIV)
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 |
|---|---|---|
| Moringa oleifera capsulesIn this arm, pregnant mothers receive capsules containing 500 mg of powdered Moringa oleifera leaves which contain 13.09 mg of iron per100 gram. Dose: 2 × 2 capsules per day for 30 days | Dietary supplement | Moringa oleifera leaf capsule |
| iron and folic acid supplementsIn this arm, pregnant mothers receive IFA tablets 2 × 1 tablet a day for 30 days. Each IFA tablet contains 400 mcg folic acid and 180 mg Ferrous Fumarate. | Dietary supplement | Iron and folic acid capsule, Moringa oleifera leaf capsule |
Primary outcome
Changes in Haemoglobin (Hb) level
Time frame: Day 0 and day 30
Hb will be meassured twice, before treatment and 30 days after treatment
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 9 Mar 2023.
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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 Phase 3 study testing Moringa oleifera capsules and iron and folic acid supplements in people with Anemia of Pregnancy, run by Universitas Padjadjaran 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 2 inclusion and 3 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 9 Mar 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Haemoglobin (Hb) level (time frame: Day 0 and day 30). 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 9 Mar 2023.