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

NCT05596006 | Completed Phase 2

• 1 other identifier: KE/FK/0191/EC/2022
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breastfeeding Mothers

Keywords

breastmilk; domperidone; neonates; ASIMOMMY®; Poly Herbal Formulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of non serious adverse event within 7 days

  Day 0 to day 7

• Proportion of serious adverse event within 7 days

  Day 0 to day 7

Study Arms (3)

ASIMOMMY®

EXPERIMENTAL

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

Drug: ASIMOMMY®

Domperidone

ACTIVE COMPARATOR

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

Drug: Domperidon

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ASIMOMMY® DRUG

ASIMOMMY 500 mg

ASIMOMMY®

Domperidon DRUG

Domperidone capsule 10 mg

Domperidone

Placebo DRUG

Capsules of placebo 500mg.

Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Primary Health Center Jetis and Tegalrejo

Yogyakarta, DI Yogyakarta, 55242, Indonesia

Location

MeSH Terms

Interventions

Domperidone

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: October 27, 2022
• Study Start: December 31, 2022
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)