Completed

Efficacy of ASIMOMMY® Compared to Domperidone and Placebo in Increasing Breastfeeding: Randomized Single-Blind Controlled Trial in Indonesia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

ASIMOMMY®

+ Domperidon

+ Placebo

Drug
Who is being recruted

From 20 to 35 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: December 2022
See protocol details

Summary

Principal SponsorGadjah Mada University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 31, 2022

Actual date on which the first participant was enrolled.

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 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shown that ASI MOMMY® is works actively as a galactogogue and is not toxic, therefore it is safe to be given to humans (unpublished), No research has been done to test the benefits of ASI MOMMY® in increasinng breastmilk production.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

Official TitleEfficacy of ASIMOMMY® Compared to Domperidone and Placebo in Increasing Breastfeeding: Randomized Single-Blind Controlled Trial in Indonesia
NCT05596006
Principal SponsorGadjah Mada University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 20 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate
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).

Show More Criteria

8 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Experimental: 2 capsules of ASIMOMMY, orally one times daily from days 1 to 7

Group II

Active Comparator
Domperidone capsule, one capsule, orally three times daily from days 1 to 7

Group III

Placebo
Identical 2 capsules of placeb, orally one times daily from days 1 to 7

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Primary Health Center Jetis and Tegalrejo

Yogyakarta, IndonesiaOpen Primary Health Center Jetis and Tegalrejo in Google Maps
CompletedOne Study Center