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

The purpose of this study is assess the efficacy of ASIMOMMY® in increasing breast milk production in postpartum mothers.

Study Overview

• Status: Completed
• Conditions: Breastfeeding Mothers
• Intervention / Treatment: Drug: ASIMOMMY®; Drug: Domperidon; Drug: Placebo

Detailed Description

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shown that ASI MOMMY® is works actively as a galactogogue and is not toxic, therefore it is safe to be given to humans (unpublished),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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Andini Juwan Prabandari, MD; Phone Number: 082220358710; Email: andini.juwan.p@gmail.com

Study Locations

• Indonesia
  • DI Yogyakarta
    • Yogyakarta, DI Yogyakarta, Indonesia, 55242
      • Primary Health Center Jetis and Tegalrejo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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
• Infants and mothers who did not participate in the treatment until completion (day 7 of the intervention).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASIMOMMY®; Experimental: 2 capsules of ASIMOMMY, orally one times daily from days 1 to 7	Drug: ASIMOMMY®; ASIMOMMY 500 mg
Active Comparator: Domperidone; Domperidone capsule, one capsule, orally three times daily from days 1 to 7	Drug: Domperidon; Domperidone capsule 10 mg
Placebo Comparator: Placebo; Identical 2 capsules of placeb, orally one times daily from days 1 to 7	Drug: Placebo; Capsules of placebo 500mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in Neonates Weight	The primary outcome is the difference in the neonates weight after 7 days of treatment with ASIMOMMY® compared to mothers receiving domperidone and placebo (mean day 7 neonates weight minus mean day 0 neonates weight).	Day 0 to day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of non serious adverse event within 7 days	Number of mothers or neonates who had non serious adverse event from day 0 to day 7 with ASIMOMMY® compare to mother receiving Domperidone and Placebo	Day 0 to day 7
Proportion of serious adverse event within 7 days	Number of mothers or neonates who had serious adverse event from day 0 to day 7 with ASIMOMMY® compare to mother receiving Domperidone and Placebo	Day 0 to day 7

Collaborators and Investigators

• Sponsor: Gadjah Mada University

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2022
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): March 24, 2023

Study Registration Dates

• First Submitted: October 23, 2022
• First Submitted That Met QC Criteria: October 23, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: neonates; breastmilk; domperidone; ASIMOMMY®; Poly Herbal Formulation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine Antagonists; Domperidone
• Other Study ID Numbers: KE/FK/0191/EC/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No