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Effect of Moringa Oleifera Leaf on Hemoglobin Levels in Anemia

Primary Purpose

Anemia of Pregnancy

Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Moringa oleifera capsules
iron and folic acid supplements
Sponsored by
Universitas Padjadjaran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia of Pregnancy

Eligibility Criteria

15 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Pregnant women with 2nd and 3rd trimester of pregnancy Pregnant women with mild to moderate anemia At day 90 after treatment Exclusion Criteria : Hypotensive pregnant women Pregnant women with Gemelli Pregnant women with chronic diseases (hepatitis and HIV)

Sites / Locations

  • University Padjajaran

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moringa oleifera leaf capsule

Iron and folic acid capsule

Arm Description

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

Subjects in this arm only receive iron and folic acid (IFA) tablets

Outcomes

Primary Outcome Measures

Changes in Haemoglobin (Hb) level
Hb will be meassured twice, before treatment and 30 days after treatment

Secondary Outcome Measures

Full Information

First Posted
February 10, 2023
Last Updated
March 6, 2023
Sponsor
Universitas Padjadjaran
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1. Study Identification

Unique Protocol Identification Number
NCT05737862
Brief Title
Effect of Moringa Oleifera Leaf on Hemoglobin Levels in Anemia
Official Title
Effect of Moringa Oleifera Leaf Capsul on Hemoglobin Levels in Anemia: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitas Padjadjaran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moringa oleifera leaf capsule
Arm Type
Experimental
Arm Description
Subjects in this arm receive experimental capsules containing powdered Moringa oleifera leaf capsules along with IFA tablets
Arm Title
Iron and folic acid capsule
Arm Type
Active Comparator
Arm Description
Subjects in this arm only receive iron and folic acid (IFA) tablets
Intervention Type
Dietary Supplement
Intervention Name(s)
Moringa oleifera capsules
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
iron and folic acid supplements
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Haemoglobin (Hb) level
Description
Hb will be meassured twice, before treatment and 30 days after treatment
Time Frame
Day 0 and day 30

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant women with 2nd and 3rd trimester of pregnancy Pregnant women with mild to moderate anemia At day 90 after treatment Exclusion Criteria : Hypotensive pregnant women Pregnant women with Gemelli Pregnant women with chronic diseases (hepatitis and HIV)
Facility Information:
Facility Name
University Padjajaran
City
Bandung
State/Province
West Java
ZIP/Postal Code
40161
Country
Indonesia

12. IPD Sharing Statement

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Effect of Moringa Oleifera Leaf on Hemoglobin Levels in Anemia

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