Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients

July 6, 2022 updated by: Vorapong Phupong, Chulalongkorn University

Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients: A Double Blind Randomized Controlled Trial

The purpose of this study is to assess the effect of Moringa oleifera leaf capsule in increasing breast milk volume

Study Overview

Status

Completed

Conditions

Postpartum Women

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Thailand
- - Bangkok, Thailand, 10330
    - Faculty of Medicine, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Postpartum women

Exclusion Criteria:

Postpartum women with contraindication for breast feeding such as HIV, untreated tuberculosis, on chemotherapeutic drugs, on radioactive drugs, substance abuse.
Postpartum women with unstable conditions such as postpartum hemorrhage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: OTHER
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Moringa oleifera leaf Participants received Moringa oleifera leaf 450 mg capsule orally twice daily for 3 days.	Drug: Moringa oleifera leaf 450 mg capsule
PLACEBO_COMPARATOR: Placebo Participants received placebo capsule orally twice daily for 3 days.	Drug: Placebo placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast milk volume at postpartum day 3 Time Frame: day 3	Breast milk volume measuring by weighting the infant fully clothed before and after each feeding with an electronic weigh scale for the period of 24 hours (at postpartum day 3). The sum of weight difference in gram was then converted to breast milk volume in milliliter (1 g = 1 mL).	day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of good satisfaction Time Frame: 3 days	satisfaction evaluated by 5 scales	3 days
quality of life scores Time Frame: 3 days	Quality of life measuring by Thai version of WHO-QOL questionaire	3 days
side effects Time Frame: 3 days	percentage of side effects such as headache, nausea/vomiting	3 days
Compliance Time Frame: 3 days	percentage of complete drug use	3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2021

Primary Completion (ACTUAL)

May 31, 2022

Study Completion (ACTUAL)

June 30, 2022

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (ACTUAL)

July 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 6, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

704/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients