Efficacy of ASIMOMMY® Compared to Domperidone and Placebo in Increasing Breastfeeding: Randomized Single-Blind Controlled Trial in Indonesia
Phase: PHASE2
Conditions: Breastfeeding Mothers
Sponsor: Gadjah Mada University

PROTOCOL ASIMOMMY® 2022 
Efficacy of ASIMOMMY® Compared to Domperidone and Placebo in 
Increasing Breastfeeding: Randomized Single-Blind Controlled Trial 
in Indonesia 
 
 
 
 
Lead Investigator (LI):  dr. Andini Juwan Prabandari 
Project Manager 1: Ummi Noor Hasanah, S.Kep., Ns 
Project Manager 1: Ika Primantari, S.Tr.Keb 
Sponsor: UGM & PT Swayasa Prakarsa 
Trial Advisor: Prof. Dr. Mustofa, MKes., Apt. 
dr. Jonathan Hasian Haposan, MPH 
Trial Coordinator: Dr. dr. Setyo Purwono, M.Kes, Sp.PD 
Data Safety Monitoring Board: Dr. dr. Diah Rumekti H, Sp.O.G. Subsp. K.Fm., MSc 
Coordinator Site 1: dr. Naufal 
Coordinator Site 2: dr. Kristi 
Biostatistician: Pak Zulaela 
 
Center: Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada 
Tlp: 082220358710 
 
Site 1: Primary Health Care Jetis 
Address: Jl. Pangeran Diponegoro No.91, Bumijo, Kec. Jetis, Kota Yogyakarta, Daerah Istimewa 
Yogyakarta 55231 
 
Site 2: Primary Health Care Tegalrejo 
Address: Jl. Magelang No.180, Karangwaru, Kec. Tegalrejo, Kota Yogyakarta, Daerah Istimewa 
Yogyakarta 55242 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The information contained in this document is the property of Universitas Gadjah Mada (UGM) 
and is confidential. It may be submitted to a Regulatory Authority, an Institutional Review 
Board/Ethics Committee, or an Investigator or a Pharmacist for the purpose of assessment in 
relation to registration of the product or initiation of a clinical trial. Reproduction or disclosure 
of the information in whole or in part is forbidden without the written consent of UGM. This 
document must be returned to UGM upon request. 

PROTOCOL ASIMOMMY® 2022 
TABLE OF CONTENTS 
1. LIST OF ABBREVIATIONS 
2. STUDY SYNOPSIS AND SCHEMA 
3. STUDY FLOW CHART OR TIME AND EVENT TABLE 
4. INTRODUCTION 
4.1 BACKGROUND 
5. PURPOSE 
6. BENEFIT 
7. INFORMATIONAL RELATED TO THE THERAPHY 
8. STUDY DESIGN 
8.1 OVERVIEW OF THE STUDY DESIGN 
8.2 DURATION OF THE STUDY AND VISIT SCHEDULE 
9. STUDY POPULATION  
9.1 Subject Recruitment 
9.2 Study Populations 
9.3 Inclusion Criteria 
9.4 Exclusion Criteria 
9.5 Number of CTP Sites 
9.6 CTP Characteristics 
9.7 Rationale for CTP Selection 
10. CLINICAL TRIAL PROCEDURES 
10.1 Recruitment and Enrollment 
10.2 Recruitment Plan 
10.3 Initial Subject Screening 
10.4 Informed Consent Prosedure 
10.5 Baseline Assessment 
10.6 Randomization 
10.7 Treatment 
10.7.1 Subject Discontinuation Criteria 
10.7.2 Treatment Discontinuation 
10.7.3 Replacement of Subject 
10.7.4 Follow-up of Withdrawn Subject 
10.8 Follow Up 
10.9 Blinding 
10.9.1 Type(s) of Blinding 
10.9.2 Maintenance of Blinding 
10.9.3 Breaking the Blinding 
10.10 Preventions of the Subject Dropout 
11. STUDY TREATMENT 
11.1 Study Intervention 
11.2 Dispencing of Study Medications 
11.3 Drug Packaging/handling/Storage/Accountability 
11.4 Training procedure 

PROTOCOL ASIMOMMY® 2022 
12. CONCOMITANT THERAPHY 
12.1 General Consideration 
12.2 Medications Prohibited Before or During the Trial 
13. STUDY ASSESSMENT 
14. STATISTICAL ANALYSIS 
14.1 General Design 
14.2 Ratinale for Sample Size and Statistical Power 
14.3 Statistical Methods for Primary and Secondary Outcomes 
14.4 Significance Testing 
14.5 Demographic and Baseline Characteristics 
14.6 Safety analysis  
15. DATA AND SAFETY MONITORING PLAN 
15.1 Data and Safety Monitoring Board 
15.2 Safety Monitoring 
16. DATA MANAGEMENT AND PROCEDURES 
17. HUMAN SUBJECTS PROTECTION 
17.1 Informed Consent/ Assent 
17.2 Subject Confidentiality/ Privacy 
17.3 Compensation for Treatments 
18. REGULATORY AND ADMINISTRATIVE COSIDERATION 
18.1 IRB Approval 
18.2 Law and Regulation 
18.3 Publication and Data Sharing Policy 
18.4 Conflict of Interest 
18.5 BPOM Registration 
18.6 Reporting to Sponsor 
19. SIGNATURE 
20. APPENDICES 
20.1 Serious Adverse Event Report 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL ASIMOMMY® 2022 
1. LIST OF ABBREVIATIONS 
GCP: Good Clinical Practice 
DSMB: Data Subject Monitoring Board 
ASI: Air Susu Ibu 
RCT: Randomized Control Trial 
CTP: Computed Tomography Perfusion 
 
2. STUDY SYNOPSIS AND SCHEMA 
Study Synopsis 
Title 
Efficacy of ASIMOMMY® Compared to Domperidone and Placebo 
in Increasing Breastfeeding: Randomized Single-Blind Controlled 
Trial in Indonesia. 
Purpose 
Assessing the efficacy of ASIMOMMY® in increasing breast milk 
production in postpartum mothers. 
Hypothesis 
ASI MOMMY® increases milk production in postpartum mothers. 
Methodology 
 Study Design 
Randomized Controll Trial (RCT). 
 Study Time 
October 2022 until March 2022. 
 Study Location 
Tegalrejo and Jetis Primary Health Care, Yogyakarta. 
Study Product 
     Treatment group 
ASI MOMMY®. 
     Control group: 
Domperidone and placebo. 
Subject Criteria: 
     Inclusion Criteria: 
• 
Mothers 20-35 years old. 
• 
Gestational age at delivery 37-40 weeks. 
• 
Vaginal delivery. 
• 
Normal body mass index (BMI 18.5-24.9 kg/m2). 
• 
Not taking drugs or breast milk enhancement supplements. 
• 
Healthy mother's condition with normal nipples (protruding). 
• 
Healthy baby condition with good suction reflex. 
• 
The baby consumes only breast milk. 
     Exclusion criteria: 
• 
Allergy to ASI MOMMY® and Domperidon.  
• 
The mother is taking medications that affect the effects of 
domperidone (such as antacids, cimetidine, ranitidine, famotidine 
and nizatidine) or medications that interact with domperidone 
(such as haloperidol, lithium). 
• 
The mother is in a state of illness requiring hospitalization. 
• 
Mother has HIV AIDS, heart problems, mastitis, and had 
undergone breast surgery. 
• 
Underweight, overweight and obese mothers. 
• 
Giving birth to twins. 
• 
The baby has a congenital defect that affects the suctioning 
process of breast milk 

PROTOCOL ASIMOMMY® 2022 
• 
Infants and mothers who did not participate in the treatment until 
completion (day 7 of the intervention). 
Sampel size 
The sample size was 15 subjects per group. The total sample size 
was 45 subjects. 
Subject 
Allocation 
Method 
Randomization with a randomization list. 
Intervention 
• 
Beginning of the study is on day 3 postpartum, the initial baby 
weight was weighed before the start of the intervention. 
• 
The weighing was conducted at Tegalrejo and Jetis Primary 
Health Center, at 08.00-10.00 WIB using Onemed OD-231 
digital baby scales with an accuracy of 0.01 kg. When weighing 
the baby did not wear clothes or pampers. 
• 
Body weight weighing was carried out at Tegalrejo and Jetis 
Primary Health Center, at 08.00-10.00 WIB using Onemed OD-
231 digital baby scales with an accuracy of 0.01 kg. When 
weighing babies do not wear clothes or pampers.  
• 
Intervention starts on the 3rd day postpartum until the next 7 days 
(10th day postpartum) with drug administration. 
• 
The intervention provided will be single-blind, the packaging 
will be similar, and neither the research assistant nor the subject 
will know the type of intervention provided. Administration of 
domperidone in capsule preparation at a dose of 10 mg orally 
taken every 8 hours, 3 times a day, for 7 days, at 06.00, 14.00, 
and 22.00 WIB. ASIMOMMY® and placebo in capsule 
preparation were taken once a day, at night, as much as 2 
capsules, for 7 days. Each subject will get all capsules on the first 
day to be taken for 7 days. 
• 
Evaluation of the baby's weight was done by re-weighing the 
baby's weight on the 7th day of the intervention. Then the baby's 
weight gain was assessed, which was obtained from the 
difference between the baby's weight on day 7 of the intervention 
and the baby's weight on day 0 (before the intervention). 
Duration of intervention 
7 days. 
Study Outcomes 
Breast milk production was measured by assessing the infant's 
weight gain, which was obtained from the difference between the 
infant's weight on day 7 of the intervention and the infant's weight 
on day 0 (before the intervention). 
Statistical Analysis 
Statistical data analysis in this study used the SPSS version 24.0 
program. Data were tested for normality first to determine the 
statistical analysis test used next. Research results with categorical 
data (nominal and ordinal) are displayed in the form of 
number/frequency and percentage of each group. Numerical data 
that is normally distributed (parametric) will be displayed in the 
mean and standard deviation, while if the data is not normally 
distributed (non-parametric) it is displayed with the median, 
minimum and maximum values. 

PROTOCOL ASIMOMMY® 2022 
Chi Square test was used for variables with categorical data (nominal 
and ordinal). The bivariate analysis test used for variables with 
numerical data (parametric) is One Way Anova with Post Hoc 
Bonferroni, while for non-parametric is Kruskall Walis with Post 
Hoc Mann Whitney. 
 
The analysis test for external variables with parametric data 
and dependent variables was carried out with the Pearson correlation 
test, while for non-parametric data it was carried out with the 
Spearman correlation test. 
 
 
 
Synopsis or Schema: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. STUDY FLOW CHART OR TIME AND EVENT TABLE 
Visit 
Screening/ 
Baseline 
Treatment/ 
Day 0 
 
Day 7 
Unscheduled 
Visit 
Visit Window 
-14 days 
- 
+0 –14 days 
- 
Informed Consent 
 
 
 
 
Pre-Screened 
Consent to be Screened
Screened 
Eligble 
Consent to be study participant (N=45) 
Randomization 
Treated (Visit 1) 
Treatment A 
(N=15) 
Treatment B 
(N=15) 
Treatment C 
(N=15) 
Follow-up after 7 days (Visit 2) 
Finished 

PROTOCOL ASIMOMMY® 2022 
Assign subject ID 
 
 
 
 
Medical History 
 
 
 
 
Inclusion/ 
Exclusion Criteria 
 
 
 
 
Physical 
Exam 
(incl. temp, BP, 
BW) 
 
 
 
 
Randomization 
 
 
 
 
Treatment 
 
 
 
 
Adverse event 
 
 
 
 
 
4. INTRODUCTION 
a. BACKGROUND 
Breast milk is the first and best source of nutrition for babies that is natural. Breast 
milk contains a variety of nutrients needed in the growth and development process of the 
baby. Breast milk also plays a role in enhancing sensory and cognitive development, and 
protects infants against infectious diseases. 
The World Health Organization (WHO) recommends exclusive breastfeeding for the 
first six months of infancy to achieve optimal growth and development (Kramer and 
Kakuma, 2012). Exclusive breastfeeding has been shown to reduce infant mortality from 
common diseases such as diarrhea and pneumonia. In addition, exclusive breastfeeding can 
help accelerate healing in sick infants (Kramer et al., 2001). Breastfeeding also affects 
maternal health and well-being, such as reducing the risk of ovarian cancer and breast 
cancer, and increasing family and national resources.  
Various attempts have been done since ancient times to deal with the problem of low 
breastmilk 
production 
in 
breastfeeding 
mothers. 
Pharmacological 
and 
non-
pharmacological interventions is given to increase breastmilk production.  Prescribing 
drugs that increase breastmilk supply, otherwise known as galactagogues, needs to be 
considered since breastmilk is important for a baby’s health. A modern drug that is 
indicated as a galactogogue among others is domperidone and metoclopramide. 
Domperidone is a dopamine D2 receptor antagonist. Metoclopramide falls under the same 
drug class as domperidone that works as a dopamine D2 receptor antagonist. However, in 
terms of its traits, domperidone is less permeable than metoclopramide, less soluble in 
water, and has a higher molecular weight, which in turn causes less extrapyramidal effects 
in comparison to metoclopramide. By looking at the traits and characteristics, domperidone 
is more recommended thatn metoclopramide3. 
Several traditional herbs have been used and is well known since a long time ago by 
Indonesian people to increase the production of breastmilk, such as Katuk leaves (Sauropus 

PROTOCOL ASIMOMMY® 2022 
androgynous Folium), Fenugreek (Trigonella foenum-graceum), and Moringa leaves 
(Moringa oleifera Folium). These plants have been scientifically proven through 
preclinical and even clinical research. However, not many have been further developed as 
phytopharmaceuticals that can be used in formal health services. 
In previous research, ASI MOMMY® capsules have been successfully produced in 
accordance to the traditional method of making good herbal drugs, with each capsule 
containing extracts of Katuk leaf (300 mg), Fenugreek (150 mg), and Moringa leaf (50 
mg). This formulation has gone through pharmacodynamic activity test, and acute and 
subactute toxicity test. Research has shown that ASI MOMMY® is works actively as a 
galactogogue and is not toxic, therefore it is safe to be given to humans (unpublished)4, 
No research has been done to test the benefits of ASI MOMMY® in increasinng 
breastmilk production. Therefore, this research is a clinical trial that intends to see the 
benefits of ASI MOMMY® for increasing breastmilk production in postpartum women. 
This research is a part of the previous main research that is still ongoing to this day which 
aims to develop the formulation of ASI MOMMY® as a phytopharmaceutical. 
 
5. PURPOSE 
The aim of this research is to study the benefits of ASI MOMMY® for increasing 
production of breastmilk in postpartum women. 
 
6. BENEFIT 
Benefits of conducting this research are as follows:  
a. Theoretical Benefit 
This research is hoped to be beneficial for becoming the basis of research and 
development in knowledge regarding breastmilk enhancing drugs for postpartum 
women. 
b. Academic Benefit (Scientific)  
This research is hoped to give contribution to the field of Pharmacology and 
Medicine, for studying the benefits of ASI MOMMY® traditional medicine formulation 
in increasing the priduction of breastmilk in postpartum women by looking at the 
increase in babies’ body weight. The data obtained is hoped to provide the basic data for 
developing future research studies, because there is still a lack of research about 
phytopharmaceuticals concerning breastmilk in Indonesia. 
c. Health Services 
Data collected from this research will help citizens in obtaining herbal preparations 
that is safe and effective, and backed up by scientific evidence. Aside from that, it will 
also help the government in improving programs concerning exclusively breastfeeding 
women.

PROTOCOL ASIMOMMY® 2022 
 
7.  INFORMATIONAL RELATED TO THE THERAPHY  
ASIMOMMY® is one product produced by PT Swayasa Perkasa Yogyakarta 
Indonesia which traditionally can increase the production of breastmilk. Instructions for 
product storage, ingredients and benefits of ASIMOMMY® are enclosed in the leaflet. 
ASIMOMMY® contains several different natural components such as Sauropi 
folium extract (Katuk leaf), Foenigraeci semen extract (Fenugreek), and Moringae folium 
extract (Moringa leaf). Components in ASIMOMMY® ingredients is beneficial in 
enhancing breastmilk because it is rich in nutrition that is useful in the growth and 
development of babies. 
The recommended direction for storage is to keep it in a place with temperature 
below 30 degrees Celsius, in a dry place away from sunlight exposure.  
 
8. STUDY DESIGN 
a. Overview of The Study Design 
This research is a pilot study, single blind, randomized controlled trial. 
Subjects are allocated to three groups with a randomized list. The three treatment 
groups are the intervention group, positive control group, and negative control 
group. The intervention group is the group of patients that receive ASI MOMMY®, 
the positive control group are patients that receive domperidone, and the negative 
control group is the placebo group. 
 
b. Duration of The Study and Visit Schedule 
In the beginning of this reasearch, on the third day postpartum, the babies’ 
weights are measured before starting the intervention. There are 3 treatment groups, 
a group that is given domperidone, ASI MOMMY®, and placebo. The information 
about which drug intervention given is hidden, where both the researcher and 
subjects do not know which type of treatment they are receiving. Domperidone is 
given in the form of tablet with a dosage of 10 mg orally, taken every 8 hours, three 
times a day at 06.00, 14.00, and 22.00 West Indonesia time for a duration of 7 days. 
ASI MOMMY® and placebo capsules is taken once a day at nighttime, as much as 
2 capsules for a duration of 7 days. The capsule is given to the subjects that have 
been randomised. All subjects will receive all the drugs in the first day to be taken 
for the next 7 days. The drug given is not known to the researcher nor the subject. 
Aside from that, the research asistant and family of the subjects helps monitor the 
subjects regarding the regularity and adherence of taking the drugs.  
 
9. STUDY POPULATION 
a. Subject Recruitment 
Data collection is done by healthcare providers on duty. Data collection is 
conducted starting from July 2022 until December 2022 by finding information 
about mothers in labor from Jestis and Tegalrejo public health centers. Women in 

PROTOCOL ASIMOMMY® 2022 
puerperium who meet the inclusion and exclusion criteria are gathered in the 
research until the number of samples needed is fulfilled. 
The researcher explains the research intent, method, and procedure that will 
be done to the mother. Then the mother is allowed to sign the informed consent form 
if they agree to become a research subject. The research subjects are given lactation 
counseling. Next, the research subjects are randomized by the researcher using the 
random number table with each group containing 15 subjects. The researcher will 
allocate each group with one type of treatment, that is drug A, drug B, and drug C, 
then randomization is conducted. The list of randomizations is kept by the 
researcher. 
b. Populasi  
The subject population in this research are postpartum women from 
Tegalrejo Public Health Center and Jetis Public Health Center in Yogyakarta who 
plan to breastfeed their baby.  
c. Inclusion Criteria 
a. Gestational age 37-40 weeks at labor 
b. Giving birth vaginally 
c. Normal body mass index (BMI 18.5-24.9 kg/m2) 
d. Does not consume drugs or supplements to enhance breastmilk 
e. Healthy women with normal nipple condition (protrudes) 
f. Condition of baby is health with good suction reflex 
g. Baby currently only consumes breastmilk 
d. Exclusion Criteria 
a. Allergy towards ASI MOMMY® and Domperidone 
b. Women who consumes drugs that influences the effects of domperidone (such 
as antacids, cimetidine, ranitidine, famotidine, and nizatidine) or drugs that 
interacts with domperidone (such as haloperidol, lithium). 
c. Women who are in sick condition and needs in-hospital treatment 
d. Women with HIV AIDS, heart problems, mastitis, and a history of breast surgery 
e. Underweight, overweight, and obese women 
f. Twin pregnancies 
g. Babies born with a congenital disease that affects the breastfeeding process 
h. Babies and mothers who do not follow the regimen from start to finish (seventh 
day of intervention) 
 
e. Number of CTP Sites 
Site 1 in this research is Jetis Public Health Center Yogyakarta with its 
address in Pengeran Diponegoro street number 91, Bunijo, Jetis district, Special 
Region of Yogyakarta 55231. The telephone number that can be contacted is (0274) 
554801. 

PROTOCOL ASIMOMMY® 2022 
Site 2 in this research is Tegalrejo Public Health Center Yogyakarta with its 
address in Magelang street number 180, Karangwaru, Tegalrejo district, Yogyakarta 
city 55242. The telephone number that can be contacted is (0274) 554801. 
f. CTP Characteristics 
Public Health Centers serves many aspects of basic health in the community, 
one of which is maternal and child health services. 
g. Rationale for CTP Selection 
Jetis and Tegalrejo are public health centers that provides this service and 
have a delivery room with adequate human resource and equipment. 
 
10. CLINICAL TRIAL PROCEDURE 
a. Recruitment and Enrollment 
The research team will fill the recuiter information log sheet. All subject 
candidates will receive starting information and disclose their willingness to 
participate in the clinical trial and consent to give information about their phone 
number and home address. 
b. Recruitment Plan 
Research subject candidates are recruited untul the amount of subjects fullfill 
the minimal sample amount that has been determined by the research team. 
c. Initial Subject Screening 
During initial screening the screening form will be filled, the researcher will 
fill the screening log, and if the subject candidate fullfills the inclusion and exclusion 
criteria of the research, they will be given a subject ID number by the research team. 
d. Informed Consent Prosedure 
Research subjects will be given starting information and be given the 
opportunity to ask questions if they still have questions regarding the research. After 
it is made sure that the research subjects have understood and recerived information 
about the research, the doctor or midwife on site will ask for the subject’s signature 
for willingness to participate in every step of the research. 
e. Baseline Assessment  
This study includes interviews related to the demographic data of the 
subjects. 
f. Randomization 
Randomization using random numbers that is obtained from the random 
numbers table. The randomized list is placed inside a non-transparent, sealed 
envelope and is given serial numbers according to the number of subjects. The 
envelopes are held by one of the researchers and kept in the Center. Every subject 
that fullfills the criteria to participate in the research will be reported to the Center 
and Research Site, and an envelope is taken according to the serial numbers. 
g. Treatment 
i. Subject Discontinuation Criteria 
In this research, the criteria for sample drop out includes subjects/babies who 
are sick and cannot continue participating in the research, babies who drink baby 
formula during the intervention, and subjects who consecutively skips 
consuming the capsules. 

PROTOCOL ASIMOMMY® 2022 
Termination of the intervention is done if the subject experiences side effects 
or serious adverse effects and will be examined by the research doctor for further 
observation and will receive treatment according to the research flow and placed 
in the intervention termination form. 
ii. Treatment Discontinuation 
Drug administration will end when the patient has completed the research 
process or the subject is placed under the drop out criteria. 
iii. Replacement of Subject  
Replacement of research subject is done if the number of subjects that is 
needed in the research does not fulfill the minimum amount due to drop out or 
termination of intervention. 
iv. Follow-up of Withdrawn Subject 
Subjects who withdraw due to heavy allergic reactions will receive 
monitoring by the research doctor and if the subject withdraws due to other 
dropout factors then the subject is required to give the product back to the 
research team.  
h. Follow Up 
Follow up of research subjects will be done by research assistants by giving 
periodical reminders of when to take the drug through WhatsApp broadcasting that 
is given to the research assistants by the subjects. 
i. Blinding 
i. Type(s) of Blinding 
The type of blinding done is single blind, where the researcher knows the 
type of capsule product given to each respondent, however, the respondent and 
research assistants or operator who administers the product does not know which 
type or product is given to the respondent 
ii. Maintenance of Blinding 
To maintain the blinding, the list of randomization is only kept and known 
by the researcher. 
iii. Breaking the Blinding 
The list of randomization will be opened at the end of the research when all 
the research process is finished.  
j.  Preventions of the Subject Dropout 
To prevent dropout of subjects, the research asistants will periodically 
remind the subjects when to take the capsules and schedule for next visit. 
 
11. STUDY TREATMENT 
a. Study Intervention 
i. Active Group 
The intervention group is the group of patients who receive ASI MOMMY® 
preparation. 

PROTOCOL ASIMOMMY® 2022 
1. Dose, Formulation, Rute, Duration, Hours, etc 
ASIMOMMY® formula contains extracts of Katuk leaf (Sauropus 
androgynous)  300 mg, Fenugreek (Trigonella foenum-graceum)  50 mg, and 
Moringae oleifera extract (Moringa leaf) 50 mg. The formulation is taken 
once a day at nightime, as much as 2 capsules for a duration of 7 days 
(Mustofa et al., 2020). The capsule is taken once a day at nighttime at 20.00 
as much as two capsules. 
 
ii.  Control group  
The positive control group consists of patients who receive domperidone 
1. Dose, Formulation, Route, Duration, Hours, etc 
Domperidone that is used is 10 mg dosage, taken every 8 hours for 7 
days (Paul et al., 2015). The drug is taken three times a day at 06.00, 14.00, 
and 22.00 West Indonesia Time. 
iii. Placebo group 
The negative control group consists of patients who receive placebo. 
1. Dose, Formulation, Route, Duration, Hours, etc 
Sugar inside the capsule does not give any therapeutic effect, is taken once 
a day, as much as 2 capsules, for duration of 7 days. 
b. Dispense of Study Medications 
At the first visit, research subjects are given all the drugs equivalent to the 
number of capsules that will be consumed for a week. 
c. Drug Packaging/handling/Storage/Accountability 
ASI MOMMY® is a polyherbal formula that is made in a capsule form by the herbal 
drug industry (PT Swayasa Prakarsa, Yogyakarta, Indonesia). This drug preparation is kept 
under 30 degrees celsius in a dry place away from sunlight. 
Each capsule contains extracts of Katuk leaf 300 mg, Fenugreek 150 mg, and 
Moringa leaf 50 mg. ASI MOMMY® has undergone activity testing and acute and 
subchronic toxicity testing. Research has shown that ASI MOMMY® formula works 
actively as an herbal galactogogue drug and does not have give any toxic effects, therefore 
it is safe to be given to humans (unpublished data). 
d. Training procedure  
Training will be given by experts provided by the research team to the 
research members in two sites which includes materials about the SOP, protocols, 
and entire research flow. 
 
12. CONCOMITANT THERAPHY 
a. General Considerations 
The subjects are prohibited from consuming drugs other than what is 
provided by the researchers, because it may affect the mechanism or interaction of 
the intervention drug. 

PROTOCOL ASIMOMMY® 2022 
b. Medications Prohibited Before or During the Trial 
The types of drugs prohibited during the research among others are antacids, 
cimetidine, ranitidine, famotidine and nizatidine, or drugs that interact with 
domperidone such as haloperidol and lithium. 
 
13. STUDY ASSESSMENT 
In this research, the assessments done are regarding physical examination, 
measurement of blood pressure, along with the baby’s body weight prior to and after 
the intervention. 
 
14. STATISTICAL ANALYSIS 
a. General Design 
The method used in this research is a single blind, Randomized Control Trial 
(RCT). The benchmark of this study is the measurement of the babies’ weight before 
and after the intervention therapy that is given (the research product). 
i. Hypothesis 
H0: The traditional drug preparation ASIMOMMY® does not increase 
breastmilk production in postpartum women.  
H1: The traditional drug preparation ASIMOMMY® increases breastmilk 
production in postpartum women.  
ii. Output (Endpoint) 
The output expected is that ASI MOMMY® is able to increase the production 
of breastmilk which in turn increases the weight of the baby after the mother 
receives the intervention. 
 
b. Rationale for Sample Size and Statistical Power 
Sample size is calculated using sample size formula for hypothesis testing 
on the average of more than two groups, unpaired numeric comparative in one 
measurement, are as follows (Dahlan, 2016):  
 zβ = √v2(2[v1+δ2]2−[v1+2δ2]) −√v1(v1 + δ2) (2v2 −1)F
√v1(v1 + δ2)F + v2(v1 + δ2)
 
 
Information: 
n = number of subjects in one group 
Zβ = beta standard value 20 % which is 0,84 
V1 = degree of freedom from the number of = k-1. V1 = 3-1 = 2 
V2 = degree of freedom from the number of groups k (n-1). V2 = 3(n-1) 
K = number of groups = 3 
 
𝛿2 = 𝑛∑
2
(𝑥𝑖−𝑥)
𝑠2
 

PROTOCOL ASIMOMMY® 2022 
 Xi = average of baby body weight in a group 
X1 = average of baby body weight in the domperidone and placebo group 
which is 3426,6 (Amri et al., 2020) 
X2 = average of baby body weight in the placebo group which is 3221,1 
(Amri et al., 2020) 
X3 = average of three groups is 3000 
X = overall average (3 group)  
S = combined standard deviationn 
F = Anova table value as function of type 1, V1, V2 
Alpha = type 1 error 0,05. 
i. Projected Number of Site 
Locations used in this study are two sites which are Jetis and Tegalrejo Public 
Health Centers in Yogyakarta. 
ii. Projected Number of Participant per site 
 
Total number of subjects in one place is around 22 or 23 subjects. 
 
c. Statistical Methods for primary and Secondary Outcomes 
Statisical data anlysis in this study is done using SPSS 24.0 program. The 
data undergoes normality testing first to determine which statistical analysis test will 
be used. The result of research with categoric data will be presented in the form of 
quantity/frequency and percentage from each group. Numeric data with normal 
distribution (parametric) will be presented in the form of average and standard 
deviation, whereas if the data is not distributed normally (non-parametric) then it 
will be presented using median, minimal value and maximum value. 
 
d. Significance Testing 
Chi-squared test is used for variabels with categoric data (nominal and 
ordinal). Bivariate analysis test that is used for variables with numeric data 
(parametric) is the One Way Anova test with Post Hoc Bonferroni, meanwhile for 
non parametric data is Kruskall Walis with Post Hoc Mann Whitney. 
Analytical test for variables aside from parametric data and dependent 
variables is using Pearson correlation, while non-parametric data is analysed using 
Spearman correlation 
e. Demographic and baseline Characteristics 
Research data with categoric data (nominal and ordinal) is presented in the 
form of quantity/frequency and percentage from each group. 
f. Safety Analysis 
The entire data analysis process will be done by a biostatistics expert 
appointed by the research team. 

PROTOCOL ASIMOMMY® 2022 
 
15. DATA AND SAFETY MONITORING PLAN 
a. Data and Safety Monitoring Board 
The researchers have appointed an expert if any unwanted occurrence were 
to happen, in order to conduct further assessment and interventions. 
b. Safety Monitoring 
Side effects will be noted by the research team starting from when the 
research subject signs the informed consent until three days after the last day that 
the subject consumed the research product. All data regarding side effect that arise 
is collected from the subjects and their daily cards. All side effects is noted in the 
Case Report Form (CRF). 
 
16. DATA MANAGEMENT AND PROCEDURES 
The Principal Investigator is responsible for making sure the research is conducted 
according to the protocols of Good Clinical Practice (GCP), applicable regulatory 
requirements, and that the data collected is valid. To reach this goal, this study will be 
continuously monitored and reviewed each month by the research team. 
Monitoring of clinical site is done to make sure that the rights and well-being of human 
subjects are protected, that the clinical trial data reported is accurate, complete, and able to 
be verified, and that the trial run is in accordance with the protocols/amendments currently 
approved, with GCP, and with applicable regulatory requirements. 
Clinical Monitoring Plan will be made by the sponsor and will explain in detail who will 
conduct monitoring, the frequency of monitoring done, at what level detailed monitoring 
will be done, and distribution of monitoring reports. 
Collection of private patient information will be limited by the amount needed to achieve 
the aim of this study, so that no sensitive information is unecessarily collected. 
 
17. HUMAN SUBJECTS PROTECTION 
a. Informed Consent/Assent 
Every participant must give written consent with full knowledge regarding 
the procedures involved in the research. Informed consent, approved by the IRB and 
in accordance with regulatory guidelines, must be explained thoroughly by the 
investigator or research team member including the aim of the research, method, 
benefits and risks, and signed by the subject involved in the researhc, The subjects 
are informed that participation in this study is voluntary and that they are able to 
withdraw at any time. 
b. Subject Confidentiality/Privacy 
Subjects will be informed that chosing to not participate in the research will 
not affect the treatment that they receive for therapy. Subjects will be informed that 
they consent to giving staff access to investigate confidential medical records. 

PROTOCOL ASIMOMMY® 2022 
Subjects are given enough time to read the consent form and opportunity to ask any 
questions. After the informed consent form is signed, subjects are given a copy of 
the document. 
c. Compensation for Treatment 
Participating mothers in this research will receive transportation replacement 
cost of 200.000 Rupiah from the researchers. If the subject experiences serious side 
effects, all cost of treatment for the side effects will be compensated by the research 
team. 
 
18. REGULATORY AND ADMINISTRATIVE CONSIDERATION 
a. IRB Approval 
This research has been approved by the ethical committee of the Faculty of 
Medicine, Public Health, and Nursing UGM with reference number: 
KE/FK/0191/EC/2022 per 22 February 2022. 
Deviation from protocol is non-compliance towards clinical trial protocol or 
GCP requirements. Non-compliance may come from the participants, investigator, 
or staff from study location. As a result from deviations, corrective actions must 
quickly be developed and implemented by the location site. 
All deviations/violations of protocol must be documented using CRF 
Protocol Deviation/Violation and handed over to IRB according to their guidelines 
for reporting. 
b. Law and Regulation 
This clinical study will be conducted in accordance to all national laws and 
regulations where the study is done, along with the applicable guidelines. This study 
will be registered in www.clinicaltrials.gov 
c. Publication and Data Sharing Policy 
Preparation and submission of publication manuscript which contains results 
of research must be according to the process established by the agreement between 
the participating research sponsor and institution. Publication or presentation of any 
study results must follow all applicable privacy laws. 
d. Conflict of Interest 
No conflict of interest to be reported  
e. BPOM Registration 
Results of this clinical trial will be reported and submitted to BPOM 
f. Reporting to Sponsor 
Monitoring and results of this clinical trial will be periodically reported to 
the sponsor.  
 
 
 

PROTOCOL ASIMOMMY® 2022 
 
19. SIGNATURE 
I agree to ensure that all staff members involved in this research are informed of 
their obligation in fulfilling the commitments above. 
Signature of Principal Investigator (PI)  
Date 
 
19 October 2022 
Name 
Andini Juwan Prabandari, MD. 
 
Name of Institution 
Center for Herbal Medicine, Faculty Of Medicine, Public Health, and Nursing, 
Universitas Gadjah Mada, Yogyakarta, Indonesia 
 
 
 
 
 
 
 
 
 
 

PROTOCOL ASIMOMMY® 2022 
20. APPENDICES 
19.1.  SERIOUS ADVERsE EVENT REPORT