Effect of Moringa Oleifera Leaf Capsul on Hemoglobin Levels in Anemia: A Pilot Study

Sponsor

Universitas Padjadjaran (Other)

Overall Status

Completed

CT.gov ID

NCT05737862

Collaborator

(none)

Enrollment

Location

Arms

3.9

Actual Duration (Months)

15.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Anemia of Pregnancy	Dietary Supplement: Moringa oleifera capsules Dietary Supplement: iron and folic acid supplements	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Effect of Moringa Oleifera Leaf Capsul on Hemoglobin Levels in Anemia: A Pilot Study

Actual Study Start Date :

Apr 1, 2022

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arms 1 Research this consist of two groups group treatment is given IFA tablets and Moringa oleifera capsules, The Moringa oleifera capsules contain 500 mg of powdered Moringa oleifera leaves and contain 13.09 mg of iron per100 gram. Mother pregnant given capsule leaf moringa as much as 2 × 2 capsules in a day. Giving a pregnant mother a capsule of Moringa oleifera was done for 30 days. Capsule Moringa oleifera consumed together with added tablet blood taken 2 × 1 tablet. Each IFA tablet distributed contains 400 mcg of folic acid and180 mg of Ferrous Fumarate.	Dietary Supplement: Moringa oleifera capsules The Moringa oleifera capsules contain 500 mg of powdered Moringa oleifera leaves and contain 13.09 mg of iron per100 gram. Mother pregnant given capsule leaf moringa as much as 2 × 2 capsules in a day. Giving a pregnant mother a capsule of Moringa oleifera was done for 30 days Dietary Supplement: iron and folic acid supplements added tablet blood taken 2 × 1 tablet A Day. Each IFA tablet distributed contains 400 mcg of folic acid and180 mg of Ferrous Fumarate.
Placebo Comparator: Arms 2 Research this consist of two groups group treatment is given IFA tablets and Moringa oleifera capsules. Each IFA tablet distributed contains 400 mcg of folic acid and180 mg of Ferrous Fumarate.	Dietary Supplement: iron and folic acid supplements added tablet blood taken 2 × 1 tablet A Day. Each IFA tablet distributed contains 400 mcg of folic acid and180 mg of Ferrous Fumarate.

Arm

Intervention/Treatment

Active Comparator: Arms 1

Research this consist of two groups group treatment is given IFA tablets and Moringa oleifera capsules, The Moringa oleifera capsules contain 500 mg of powdered Moringa oleifera leaves and contain 13.09 mg of iron per100 gram. Mother pregnant given capsule leaf moringa as much as 2 × 2 capsules in a day. Giving a pregnant mother a capsule of Moringa oleifera was done for 30 days. Capsule Moringa oleifera consumed together with added tablet blood taken 2 × 1 tablet. Each IFA tablet distributed contains 400 mcg of folic acid and180 mg of Ferrous Fumarate.

Dietary Supplement: Moringa oleifera capsules

The Moringa oleifera capsules contain 500 mg of powdered Moringa oleifera leaves and contain 13.09 mg of iron per100 gram. Mother pregnant given capsule leaf moringa as much as 2 × 2 capsules in a day. Giving a pregnant mother a capsule of Moringa oleifera was done for 30 days

Dietary Supplement: iron and folic acid supplements

added tablet blood taken 2 × 1 tablet A Day. Each IFA tablet distributed contains 400 mcg of folic acid and180 mg of Ferrous Fumarate.

Placebo Comparator: Arms 2

Research this consist of two groups group treatment is given IFA tablets and Moringa oleifera capsules. Each IFA tablet distributed contains 400 mcg of folic acid and180 mg of Ferrous Fumarate.

Dietary Supplement: iron and folic acid supplements

added tablet blood taken 2 × 1 tablet A Day. Each IFA tablet distributed contains 400 mcg of folic acid and180 mg of Ferrous Fumarate.

Outcome Measures

Primary Outcome Measures

Haemoglobin [30 Days]
Protein present in red blood cells. This protein makes blood red.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Willing to participate in research
Pregnant women with 2nd and 3rd trimester of pregnancy
Pregnant women with mild anemia and moderate anemia

Exclusion Criteria :

Hypotensive pregnant women
Pregnant women with Gemelli
Pregnant women with chronic diseases (hepatitis and HIV)
Pregnant women dont consume any supplements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Padjajaran	Bandung	West Java	Indonesia	40161

Sponsors and Collaborators

Universitas Padjadjaran

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol - Feb 6, 2023

More Information

Publications

None provided.

Responsible Party:

Universitas Padjadjaran

ClinicalTrials.gov Identifier:

NCT05737862

Other Study ID Numbers:

MAGPH-202210.01

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anemia

Folic Acid

Study Results

No Results Posted as of Feb 21, 2023