Effect of Moringa Oleifera Leaf on Hemoglobin Levels in Anemia

NCT05737862 | Completed Phase 3 DMC

• 1 other identifier: MAGPH-202210.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Changes in Haemoglobin (Hb) level

  Hb will be meassured twice, before treatment and 30 days after treatment

  Day 0 and day 30

Study Arms (2)

Moringa oleifera leaf capsule

EXPERIMENTAL

Subjects in this arm receive experimental capsules containing powdered Moringa oleifera leaf capsules along with IFA tablets

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

Dietary Supplement: iron and folic acid supplements

Interventions

Moringa oleifera capsules DIETARY_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

Moringa oleifera leaf capsule

iron and folic acid supplements DIETARY_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.

Iron and folic acid capsule; Moringa oleifera leaf capsule

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women with 2nd and 3rd trimester of pregnancy
• Pregnant women with mild to moderate anemia At day 90 after treatment

You may not qualify if:

• Hypotensive pregnant women
• Pregnant women with Gemelli
• Pregnant women with chronic diseases (hepatitis and HIV)

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

University Padjajaran

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Interventions

Iron

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1 group receives capsules of powdered Moringa leaves (active comparator), and the other group receives IFA tablets as part of routine clinical care.

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: April 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

ID (1)