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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2023-03-24

Brief Summary

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

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Detailed Description

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that ASI MOMMY® is works actively as a galactogogue and is not toxic, therefore it is safe to be given to humans (unpublished),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

Conditions

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Breastfeeding Mothers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ASIMOMMY®

Experimental:

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

Group Type EXPERIMENTAL

ASIMOMMY®

Intervention Type DRUG

ASIMOMMY 500 mg

Domperidone

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

Group Type ACTIVE_COMPARATOR

Domperidon

Intervention Type DRUG

Domperidone capsule 10 mg

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules of placebo 500mg.

Interventions

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ASIMOMMY®

ASIMOMMY 500 mg

Intervention Type DRUG

Domperidon

Domperidone capsule 10 mg

Intervention Type DRUG

Placebo

Capsules of placebo 500mg.

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes