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RecruitingNCT06590805Updated Sep 19, 2024

Electroacupoint for Diminutive Milk Production

An interventional study of Electrotherapy using Chattanooga stimulation unit and Balanced Diet using domperidone drug, iron, and folic acid supplementation. in Physical Therapy, Electrotherapy and Dietary Modification, sponsored by Haytham Ibrahim Morsi. Recruiting at 1 site in Egypt. Open to female participants aged 25 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Haytham Ibrahim Morsi · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
25 Years to 30 Years
Sex
Female
01

Study summary

The purpose of this study was to reveal the effect of electroacupoint on scanty milk production in lactating women.

Read the detailed description

Postnatal scanty milk secretion is a common complaint. Some physical and medicinal therapies have been proposed to enhance milk production. These therapies must be both successful and safe for both the mother and the child. In many cases, milk supply can be increased by frequent, regular milk removal, Medication to increase milk supply (galactogogues) such as domperidone.

Domperidone has been linked to maternal adverse effects in galactogogue trials and cases reported to the Food and Drug Administration include dry mouth, headache, dizziness, nausea, abdominal cramping, diarrhea, palpitations malaise, and shortness of breath. Some of these were more frequent with dosages greater than with 30 mg daily. Drug withdrawal symptoms consisting of insomnia, anxiety, and tachycardia were reported in a woman taking 80 mg of domperidone daily for 8 months as a galactogogue who abruptly tapered the dose over 3 days.

02

Conditions studied

  • Physical Therapy
  • Electrotherapy
  • Dietary Modification

Keywords

  • Electroacupoint
  • Postnatal care
  • Diminutive milk production
  • Lactating woman
03

In context

Lead sponsor

This is the only study on the registry with Haytham Ibrahim Morsi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • They were complaining of insufficiency of lactation within the first month after cesarean section.
  • They are using mixed feeding; both breast and bottle feeding, between three and six bottles per day.
  • Their age ranged from 25-30 years old.
  • Their body mass index didn't exceeded 30 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • Postpartum haemorrhage.
  • Cardiorespiratory disease.
  • Diabetes mellitus.
  • Breast cancer.
  • Previous surgeries in the chest, breast, or the surrounding area.
  • Anemia.
  • Any causes that hindered their normal breastfeeding (retraced, cracked, inflamed, or inverted nipples).
  • Receiving contraceptive pills.
  • Having infants with conditions that may affect the lactation process such as congenital abnormalities of the mouth (tongue tie, cleft palate).
  • Congenital heart disease.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Electroacupoint combined with postnatal care

    Electroacupoint stimulation using the Electroacupoint device and postnatal care diet in form of balanced diet and drinking sufficient clean water and routine postnatal care.

    Procedure: Electrotherapy using Chattanooga stimulation unit · Dietary Supplement: Balanced Diet using domperidone drug, iron, and folic acid supplementation.

  • Active comparator
    postnatal care only

    Postnatal care diet in form of balanced diet and drinking sufficient clean water and routine postnatal care.

    Dietary Supplement: Balanced Diet using domperidone drug, iron, and folic acid supplementation.

Interventions

  • ProcedureElectrotherapy using Chattanooga stimulation unit

    Electroacupoint stimulation using the Chattanooga intellect transport 2-channel electrotherapy stimulation unit 2783. It uses the influences energy flows by needling the acupuncture points which lie along the body meridians to achieve a harmonious balance between physical, emotional, and spiritual states. The same effect can be achieved without the use of needles. These needleless stimulations are noninvasive and nontraumatic and are useful for individuals who are scared of needles. They are also associated with decreased risk of infection or bruise.

  • Dietary supplementBalanced Diet using domperidone drug, iron, and folic acid supplementation.

    Postnatal care diet in form of balanced diet using domperidone drug, iron, and folic acid supplementation. Additionally, drinking sufficient clean water and routine postnatal care. It was performed by asking the participant to take ten mg domperidone three times a day after meals. Iron and folic acid supplementation were also continue for three months after birth.

06

What researchers measure

Primary outcomes

  1. Change in Baby Weight.

    Measurement of Baby Weight using the Baby Weight Scale.

    Time frame: Change from Baseline Baby Weight at three months.

  2. Change in Serum Prolactin Level.

    Measurement of Serum Prolactin Level using the Serum Blood Test.

    Time frame: Change from Baseline Serum Prolactin Level at three months.

  3. Change in Flow of Milk.

    Measurement of Flow of Milk using the Visual Analogue Scale.

    Time frame: Change from Baseline Flow of Milk at three months.

07

Study locations

1 of 1 sites recruiting
  • Kafrelsheikh University
    Kafrelsheikh, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06590805
Lead sponsor
Haytham Ibrahim Morsi
Responsible party
Haytham Ibrahim Morsi (Lecturer, Kafrelsheikh University) — Sponsor-investigator
First posted
Sep 19, 2024
Start date
Sep 1, 2024
Primary completion
Jan 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Sara E Seyam, B.Sc.
Contact
saraseyam2024@gmail.com
+201554552868
Haytham I Morsi, M.Sc.
Contact
haytham_morsi@kfs.edu.eg
+201013657738
Haytham I Morsi, M.Sc.
study director · Kafrelsheikh University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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