The Effectiveness of Malunggay (Moringa Oleifera) Capsule on the Onset of Early Lactation

Given Antepartum

_________________________________________________

A Research Proposal

Presented to the OB-GYN Department

San Pedro Hospital

________________________________________________________________

In Partial Fulfillment of the Requirements in OB-GYN Residency Training

______________________________________________________

By:

Shiely Mae Llaguno-Mundiz, M.D.

Fourth Year Resident

Co-Author:

Dr. Bernadette Yolanda A. Tuason

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Introduction

Background of the Study

Breast milk contains essential nutrients completely suitable for the infant's needs. It is

also nature's first immunization, enabling the infant to fight potential serious infection. It

contains growth factors that enhance the maturation of an infant's organ systems. (1)

Breastfeeding has distinct advantages which benefit the infant and the mother. It is the

first preventive health measure that can be given to the child at birth and also develops mother-

infant relationship. It is promoted by the DOH and WHO to be given exclusively to all

newborns and have made most of the hospitals “Baby Friendly”.

Most mothers after initiating expression of breast milk on the first few days postpartum

complain of insufficient volume of breast milk. According to Nichols F.H., it takes 3-4 days

postpartum for the establishment of adequate milk supply. Given this condition, mothers

prompted to use milk formula, shift to bottle-feeding and discontinue breastfeeding. Earlier

onset of lactation will be of much help in promoting successful exclusive breastfeeding. This

will also significantly decrease infant mortality rate.

Malunggay (Moringa Oleifera) leaves used in chicken and shellfish soups have been

utilized by generations of Filipino mothers to enhance breast milk production. It is one of the

most studied herbs in the Philippines, but usually promoted to be given postpartum to induce

and increase breast milk production.

Malunggay leaves have been in the form of Malunggay capsule. One Malunggay

capsule is equivalent to 250 mg of malunggay leaves. It is given one capsule daily 2 weeks

prior to delivery and one to two capsules daily throughout breastfeeding period.

Studies done on Malunggay capsule determine its effectiveness in enhancing the

volume of breast milk. It is given postpartum and continued throughout breastfeeding.

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However, no studies were done on giving the malunggay capsule antepartum. This pilot study

aims on giving Malunggay capsule as early as 37 weeks age of gestation to induce early onset

of lactation.

Research Question:

Are Malunggay capsules effective in inducing early lactation when given antepartum?

General Objective:

To determine the efficacy of malunggay capsules in inducing early lactation given

antepartum

Specific Objectives:

To describe baseline sociodemographic clinical profile as to age of the patient, age of

gestation, gravidity and parity.

To determine the onset of breast milk production after delivery on patients given

malunggay capsules starting 37 weeks AOG onwards.

A) every hour

B) first 24 hours

C) 48 hours

D) 72 hours

To compare the onset of breast milk production between those given with malunggay

and those who have not given malunggay.

V04, Malunggay 15 March 2017 3

Significance of the Study:

Some babies die after birth because they were not breastfed

immediately. Breastfeeding should be initiated at once – about 30 minutes after normal

delivery and about 3 – 4 hours after delivery by caesarean section. Providing breast milk within

the first hour after delivery can save up to 22% of infants from death and about 16% when they

are breastfed within the first day thus, decreasing the rate of infant mortality

significantly. Infants who were given early breastfeeding will have the opportunity to be more

successful and sustain exclusive breastfeeding.

This study aims on giving a galactogogue in the form of malunggay capsules during the

antenatal period to induce earlier lactation in the first 2 days of life.

Review of Related Literature:

The protection, promotion, and support of breastfeeding rank among the most effective

interventions to improve child’s survival. According to the World Health Organization

(WHO), it is estimated that high coverage of optimal breastfeeding practices could avert 13%

of the 10.6 million yearly deaths of children five years old and below. (5)

Human milk is widely recognized as the optimal source of nutrition for all infants.

Breast milk promotes development of the infant's immune system and meets the nutritional

needs of a full-term infant until approximately six months of age, when complementary foods

and fluids are usually added to the diet.

Lactation or galactopoiesis is the process of continued secretion of copious milk. It

requires regular removal of milk and stimulation of the nipple, which triggers prolactin release

from the anterior pituitary gland and oxytocin from the posterior pituitary gland. In the absence

V04, Malunggay 15 March 2017 4

of milk removal, elevated intramammary pressure and accumulation of a feedback inhibitor of

lactation (FIL) reduce milk production and trigger mammary involution.

Most women begin to produce large volumes of breast milk by two to three days after

delivery, although this can occur as late as seven or more days after delivery. Healthy women

who exclusively breastfeed produce approximately 750 to 800 mL (24 to 26 ounces) of milk

per day after two to four weeks, when lactation is fully established. However, milk volume

varies and can range from 450 to 1200 mL or more (15 to 40 ounces) per day.

Because perceived or actual low milk supply is one of the most common reasons given

for discontinuing breastfeeding, 1–8 both mothers and health professionals have sought

medication(s) to address this concern. Evaluation of evidence-based studies and emerging

information regarding more serious potential side effects of some galactogogues have resulted

in a recent shift in the Academy of Breastfeeding Medicine’s recommendations regarding these

drugs and herbs. In 2004, the previous version of this protocol used existing evidence that

prescription of galactogogues were effective and described when and how to use them. (4)

Malunggay (Moringa oleifera) leaves contain vitamins, minerals, and essential amino

acids as well as a number of glycosides. It is used as a galactogogue in Asia, particularly in the

Philippines where it is called malunggay. Its medicinal parts are the leaves, roots, pod and

flowers. It is planted throughout the country in settled areas at low and medium altitude.

As galactogogues, dried malunggay leaves in encapsulated form are available

commercially. Studies have shown higher prolactin levels after 48 hours in breastfeeding

mothers and significant weight gain among babies and increase in the volume of breast milk.

A large number of reports on the nutritional qualities of Moringa now exist in both the

scientific and the popular literature. Any readers who are familiar with Moringa will recognize

the oft-reproduced characterization made many years ago by the Trees for Life organization,

that “ounce-for-ounce, Moringa leaves contain more Vitamin A than carrots, more calcium

V04, Malunggay 15 March 2017 5

than milk, more iron than spinach, more Vitamin C than oranges, and more potassium than

bananas,” and that the protein quality of Moringa leaves rivals that of milk and eggs. (2)

A double-blind study done by Estrella, M.D., et. Al on the use of moringa for the

augmentation of the volume of breast milk among mothers of pre-term infants, demonstrated

the lactation-enhancing effect of malunggay leaves evidenced by the significantly greater

increase in the volume of milk expressed by mothers on the 3rd to the 5th postpartum day given

Moringa oleifera capsules compared to those given placebo. They found that those who

consumed commercially available capsules with 250mg of moringa leaves twice daily, had a

mean difference of 154-245 ml or a 152-176% increase in breast milk volume in favor of

treatment.

Raguindin, et. Al, conducted a systematic review and meta-analysis of randomized

controlled trial on Moringa oleifera as galactogogue for breastfeeding mothers. They concluded

that moringa can result in a significant increase in breastmilk volume on day 7. It also results

in improvement in the infant’s weight gain. Of the five randomized trials they reviewed, they

concluded that Moringa oleifera is safe with minimal to no adverse effects as reported by all

five studies being reviewed (7) .

There are only a few true contraindications to breastfeeding. These include

galactosemia, in severe maternal conditions such as heart failure, serious kidney, liver or lung

disease and rarely from a few maternal drugs including amethopterin, thiouracil and radioactive

or chemotherapeutic therapy. (3)

Another study done by Yabes-Almirante, M.D, et. Al, determined a causal relationship

of moringa capsule intake with increased milk production by demonstrating increased serum

prolactin levels. They concluded that malunggay capsules do enhance lactation among

breastfeeding mothers and there were no reported adverse effects from the study. (6)

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Definition of Terms:

1. Galactogogues (or lactogogues) = medications or other substances believed to assist

initiation, maintenance, or augmentation of the rate of maternal milk synthesis

2. Breastmilk = is the milk produced by the breasts (or mammary glands) of

a human female for her infant offspring

3. Malunggay capsules = encapsulated in a commercial preparation containing 250 mg of

leaves of Moringa Oleifera

4. Breastfeeding = is feeding of infants or young children with breast milk from human

breasts

5. No-treatment Comparison Condition = outcomes for people randomly assigned to

receive the new treatment are compared to those of people assigned to receive no

treatment at all. The question is whether the new treatment produces any benefit at all,

over and above change due to the passage of time or the effects of participating in a

study.

6. Fixed Block Size = participants are first classified into groups (blocks) of a fixed

length (usually 4, 6, or 8), on the basis of a variable that the experimenter wishes to

control. Individuals within each block are then randomly assigned to one of several

treatment groups.

MATERIALS AND METHODS:

Research design: Randomized Controlled Trial

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Study Setting: San Pedro Hospital

Sample Population:

All primigravid patients consulting for prenatal check-ups are the target population of

the study.

Inclusion criteria:

All primigravid patients at 19-35 years of age, at least 37 weeks age of gestation with

at least four prenatal check-ups are included in the study.

Exclusion criteria:

Pregnant women with maternal conditions that would have an effect on breast milk

production and contraindications to breastfeeding. (E.g. Advanced pulmonary tuberculosis,

extra-pulmonary spread of TB, Rubella, renal problems, retracted nipples, anemia, and

pneumonia)

Sampling Design:

Sampling design is a simple comparison using the with and without intervention modality. The

subjects with intervention group refer to the test subjects which will be given 1 malunggay

capsule twice a day starting 37 weeks age of gestation. The subjects without intervention group

refer to control subjects of those who don’t have the above treatment (malunggay capsule).

Sample Size Estimation:

At least 38 research subjects will be identified as experimental or test group while another 38

subjects will be selected as control group. Sample size is based on the average number of

V04, Malunggay 15 March 2017 8

deliveries (see table below). A 3% margin of error is applied on the computation of sample

size.

Total
Monthly Number of Primigravid Multigravid
Deliveries
January 2016 74 25 49
February 2016 64 32 32
March 2016 78 27 51
April 2016 65 33 32
May 2016 67 43 24
June 2016 66 33 33
July 2016 70 37 33
August 2016 69 30 39
September 2016 91 41 50
October 2016 81 42 39
November 2016 64 26 38
December 2016 86 51 35
Total 875 420 455
Average 73 35 38

Slovins formula:

Where:

n = sample size (68) + (8) = 76

N = target cases (73 recorded cases)

e2 = margin of error (3%)

note: an additional 10% (8) on the computed sample size is required to address the non-

cooperating respondents and other non-avoidable circumstances in conducting the research.

Data Collection Procedures:

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Data Collection Process

Subjects will be equally divided into two groups, Subject T (Test) and Subject C

(Control). The subjects will be selected using blocked randomization. The subjects will be

randomized with a fixed block size of 4 by the researcher, then the subjects can be allocated in

any of the orders: TTCC, TCTC, CTCT, TCCT, CTTC, or CCTT. The order is chosen

randomly at the beginning of the block.

The researcher uses a no-treatment comparison condition. Those who are under

Subjects T will be instructed to take Moringa oleifera leaves in a commercial capsule

preparation 250 mg every 12 hours starting 37 weeks age of gestation. Intake of the malunggay

capsules will be discontinued once the mother had the onset of breast milk production. Those

who are under Subjects C, malunggay capsules will not be given and the onset of breast milk

production will be determined and recorded.

After delivery, the newborn baby is allowed to suck from the mother’s breast and must

check if the milk drips from the mother’s breast. Furthermore, the mothers will be instructed

to note and record the onset of breast milk production. Subjects who do not have onset of breast

milk production during admission will continue to note and record the onset of breast milk

production at home. Subjects T will be given compliance diary to ensure compliance on taking

malunggay capsule at home and another record sheet to document the onset of breast milk

production. Subjects C will also be given a record sheet to note and record the onset of breast

milk production at home. The researcher will follow up the subjects daily through a telephone

call. The subjects can choose a time that is most convenient for them to accept the call. The

record sheet will be checked at once after the onset of breast milk production is determined.

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 Co-interventions such as multivitamins and malunggay containing food and soup are

allowed. Subjects with co-interventions can be monitored thru the mother’s food and intake

with the subject’s diet diary.

Data Analysis

The t-test for independent groups will be employed to test the hypothesis that there is a

significant difference in the lactation of the two groups. T-test for independent samples is used

for small samples. The demographic and clinical profile characteristics of patients will be

analyzed using descriptive statistics such as mean and standard deviation and frequency

distribution for categorical data.

Expected Outcomes of the Study

This study aims on giving a galactogogue in the form of malunggay capsules during the

antenatal period to induce earlier lactation. If effectiveness of malunggay capsule in inducing

early onset of lactation is warranted, we could recommend early intake of malunggay capsule

starting at 37 weeks age of gestation.

Ethics Review Process

The research protocol will be submitted to the Department Research Committee and

San Pedro Hospital’s Institutional Review board for technical and ethics review, respectively.

Data collection will commence once approval are secured.

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 Those who will fulfill the inclusion criteria will be the subjects of this study. The

purpose, nature, and procedure of the research will be explained to the patient by the researcher.

After which, informed written consent will be secured. Upon enrollment to the study, the

patient will be interviewed for their sociodemographics and clinical profile. The following data

will be collected: age of the patient, gravidity and parity, age of gestation.

Once eligible, subjects will be asked to sign an informed consent before involving them

in the study.

Disclosure of Study Objectives

To describe baseline sociodemographic clinical profile as to age of the patient, age of

gestation, gravidity and parity.

To determine the onset of breast milk production after delivery on patients given

malunggay capsules starting 37 weeks AOG onwards.

every hour

first 24 hours

48 hours

72 hours

To compare the onset of breast milk production between those given with malunggay

and those who have not given malunggay.

Disclosure of Inclusion criteria:

All primigravid patients at 19-35 years of age, at least 37 weeks age of gestation with

at least four prenatal check-ups are included in the study.

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Disclosure of Exclusion criteria:

Pregnant women with maternal conditions that would have an effect on breast milk

production and contraindications to breastfeeding. (E.g. Advanced pulmonary tuberculosis,

extra-pulmonary spread of TB, Rubella, renal problems, fever, retracted nipples, anemia, and

pneumonia)

Disclosure of Procedures

Subjects will be equally divided into two groups, Subject T (Test) and Subject C

(Control). The subjects will be selected using blocked randomization. The subjects will be

randomized with a fixed block size of 4, then the subjects can be allocated in any of the orders:

TTCC, TCTC, CTCT, TCCT, CTTC, or CCTT. The order is chosen randomly at the beginning

of the block.

The researcher uses a no-treatment comparison condition. Those who are under

Subjects T will be instructed to take 1 malunggay capsule twice a day starting 37 weeks age of

gestation. Intake of the malunggay capsules will be discontinued once the mother had the onset

of breast milk production. Those who are under Subjects C, malunggay capsules will not be

given and the onset of breast milk production will be determined and recorded.

After delivery, the newborn baby is allowed to suck from the mother’s breast and must

tcheck if the milk drips from the breast. Furthermore, the mothers will be instructed to note and

record the onset of breast milk production. Subjects who do not have onset of breast milk

production during admission will continue to note and record the onset of breast milk

production at home. Subjects T will be given compliance diary to ensure compliance on taking

malunggay capsule at home and another record sheet to document the onset of breast milk

production. Subjects C will also be given a record sheet to note and record the onset of breast

milk production at home. The researcher will follow up the subjects daily through a telephone

V04, Malunggay 15 March 2017 13

call. The subjects can choose a time that is most convenient for them to accept the call. The

record sheet will be checked at once after the onset of breast milk production is determined.

Co-interventions such as multivitamins and malunggay containing food and soup are

allowed. Subjects with co-interventions can be monitored thru the mother’s food and intake

with the subject’s diet diary.

Disclosure of study benefits or advantages

Malunggay capsules will be provided by the researcher at no charge to the subject.

There may not be any benefit for the subject but subject’s participation is likely to help us find

the answer to the research question. The future generations are likely to benefit from this study.

Disclosure of harms and risks

Side Effects

As already mentioned, this drug has no known side effects. However, we will follow

the subjects closely and keep track if any unwanted effects or any problems may arise. In case

of adverse effects occur, the researcher will shoulder the cost of the medical treatment.

Risks

By participating in this research, it is possible that the subject will be at greater risk

than they would otherwise be. There is, for example, a risk that the subject will have breast

engorgement and breast pain due to expansion and pressure exerted by the synthesis and

storage of breast milk.

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 While the possibility of this event is low, the subject should still be aware of the

possibility. The researcher will try to decrease the chances of this event occurring, but if

something unexpected happens, the researcher will provide pain reliever to the subject and

will apply warm and cold compress on the affected breast.

Appropriate safeguard to protect the subject and baby

The primary concern of the investigator is the safety of the research subjects including

the baby. The primary investigator uses all available information to identify potential risks to

the subject, to establish means of minimizing those risks, and to continually monitor the

ongoing research for adverse events experienced by subjects. The primary investigator is

willing to stop the study if serious unanticipated risks are manifest.

Informed consent is obtained from each research participant. It is obtained in writing

after the participant had the opportunity to carefully consider the risks and benefits and to ask

any pertinent questions. Informed consent should be seen as an ongoing process, not a single

event or a mere formality.

The primary investigator protects the subjects’ privacy and confidentiality. To prevent

the disclosure of, or unauthorized access to, data that can be linked to a subject’s individual

identity, the all demographic profile and informed consent forms will be kept in a locker. Only

the primary investigator will have the access to the key of the said locker.

In cases of adverse events, the primary investigator will provide care for the participant

injured in a study for example; high BP, fever, etc. Adverse events are considered related to

malunggay intake if there is a sudden reaction upon onset of intake. It is important to note the

time from the start of intake to onset of reaction.

V04, Malunggay 15 March 2017 15

Options to withdraw and alternation options

The subject does not have to take part in this research if the subject does not wish to do

so. The subject may also stop participating in the research at any time the subject choose. All

the subject’s rights will still be respected.

Confidentiality

The information that the researcher collect from this research project will be kept

confidential. The information about the subject that will be collected during the research, will

be put away and no-one but the researcher will be able to see it. Any information about the

subject will have a number on it instead of the subject’s name. Only the researcher will know

the number of the subject and will lock that information up with a lock and key. It will not be

shared with or given to anyone.

Disclosure of Sharing the Result

The knowledge that we get from doing this research will be shared with the subjects before it

is made widely available to the public. Confidential information will not be shared.

Compensation, Remuneration, and Reimbursement

Malunggay capsules will be provided by the researcher at no charge to the subject.

Extent of use of the study

The research takes place starting at 37 weeks age of gestation until onset of lactation.

Authorship

Primary author: Dr. Shiely Mae Llaguno-Mundiz

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 Secondary author: Dr. Bernadette Yolanda Tuason

Contributorship

Complete name of the Contributing Author: Mr. Nelson Faustino (statistician)

Declaration of Conflicts of Interest

This study has no conflict of interest.

Source of Funding

This study is an investigator-initiated research project.

Contact Details

Primary Author: Dr. Shiely Mae Llaguno-Mundiz

 San Pedro Hospital, C. de Guzman St., Davao City

 09235388053

 082-227-71-12

Secondary Author: Dr. Bernadette Yolanda Tuason

 San Pedro Hospital, C. de Guzman St., Davao City

 09228701713

IERC Chair: Dr. Chita I. Nazal-Matunog

 San Pedro Hospital, C. de Guzman St., Davao City

 09776743851

V04, Malunggay 15 March 2017 17

 RESULTS AND DISCUSSION

Results and Interpretation

Onset Of Breast Milk Production on Control Subjects

Control Hours Minutes

Subjects
C1 4 7

C2 6 44

C3 41 45

C4 8 10

C5 3 0

C6 29 57

C7 2 25

C8 5 12

C9 4 50

C10 17 28

C11 3 7

C12 21 37

C13 24 46

C14 19 34

C15 3 50

C16 4 22

C17 6 56

C18 14 56

C19 40 41

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 C20 14 32

C21 41 13

C22 23 59

C23 31 0

C24 12 14

C25 10 7

C26 9 18

C27 37 11

C28 38 24

C29 5 49

C30 5 26

C31 21 18

C32 45 0

C33 3 48

C34 9 55

C35 9 24

C36 8 0

C37 9 19

C38 7 9

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 Onset Of Breast Milk Production on Test Subjects

Test Hours Minutes

Subjects
T1 5 38

T2 30 32

T3 9 48

T4 5 35

T5 48 0

T6 24 0

T7 57 35

T8 0 0

T9 40 17

T10 22 24

T11 23 46

T12 3 52

T13 75 38

T14 8 4

T15 29 30

T16 5 38

T17 12 0

T18 7 40

T19 56 59

T20 41 5

T21 36 29

T22 68 40

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 T23 0 0

T24 45 38

T25 20 22

T26 48 0

T27 11 58

T28 60 11

T29 3 30

T30 11 57

T31 92 22

T32 11 2

T33 25 21

T34 21 0

T35 26 51

T36 13 31

T37 7 0

T38 16 0

SUMMARY, CONCLUSIONS, AND RECOMMENDATIONS

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References:

1. Jed W. Fahey, Sc.D. Johns Hopkins School of Medicine, Department of

Pharmacology and Molecular Sciences, Lewis B. and Dorothy Cullman Cancer

Chemoprotection Center, 725 N. Wolfe Street, 406 WBSB, Baltimore, Maryland,

USA 21205-2185)

2. "Expanded Breastfeeding Promotion Act of 2009"

V04, Malunggay 15 March 2017 22

 3. Department of Health. Unang Yakap Flyer. Available

at: http://www.wpro.who.int/NR/rdonlyres/2931B641-DD16-487B-A979-

77A9C561BAA9/0/UnangYakapFlyer.pdf (accessed on 30 March 2011

4. Academy of Breastfeeding Medicine. Use of Galactogogues in Initiating or

Augmenting Maternal Milk Supply 2004. www.bfmed.org/Resources/Protocols.aspx

(accessed December 3, 2010

5. WHO. Newborns: Reducing Mortality. August 2009. Available

at: http://www.who.int/mediacentre/factsheets/fs333/en/(accessed on 30 March 2011)

6. Effectiveness of Natalac as Galactogogue, Corazon Yabes-Almirante, M.D., et. Al.

JPMA Vol. 71 No. 3, January-March 1996.

7. King J, Raguindin P, et. Al, Moringa oleifera as galactogogue for breastfeeding

mothers: A systematic review and meta-analysis of randomized controlled trial. Phil J

Pediatric 201361 (2):34-42

DEMOGRAPHIC PROFILE

DATE:

CONTROL NUMBER:

V04, Malunggay 15 March 2017 23

AGE:

OBSTETRICAL SCORE:

AGE OF GESTATION:

CONTACT NUMBER:

SIGNATURE:

RECORD SHEET ON THE ONSET OF BREAST MILK PRODUCTION

CONTROL NUMBER: _____________________________________________________

DATE AND TIME OF DELIVERY: _________________________________________

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 ONSET OF BREAST
HOURS
MILK
AFTER FOOD INTAKE SIGNATURE
PRODUCTION
DELIVERY
(YES OR NO)
1

10

11

12

13

14

15

16

17

18

19

20

21

22

V04, Malunggay 15 March 2017 25

 23

24

48

72

Checked and Verified by:

______________________________

SIGNATURE ABOVE PRINTED NAME

_____________________________

SIGNATURE ABOVE PRINTED NAME

COMPLIANCE DIARY ON MALUNGGAY CAPSULE INTAKE

CONTROL NUMBER: ____________________________________________________

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AGE OF GESTATION: _____________________________________________________
DATE AND TIME OF DELIVERY: ___________________________________________

INTAKE OF
MALUNGGAY
DATE FOOD INTAKE SIGNATURE
CAPSULE
(YES OR NO)

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Checked and Verified by:

______________________________

SIGNATURE ABOVE PRINTED NAME

_____________________________

SIGNATURE ABOVE PRINTED NAME

STUDY BUDGET

Item Quantity Unit Price Total Unit

Malunggay capsule 1, 596 8.00 12, 768.00

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 Professional Service 1 6,000.00 6,000.00
Statistician
Binding 3 80.00 240.00

Total 19,008.00

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