Physical TherapyNCT06590805
Electroacupoint for Diminutive Milk Production
A study testing Electrotherapy using Chattanooga stimulation unit and Balanced Diet using domperidone drug, iron, and folic acid supplementation. in people with Physical Therapy and Electrotherapy, run by Haytham Ibrahim Morsi at 1 site in Egypt.
Trial summary
The purpose of this study was to reveal the effect of electroacupoint on scanty milk production in lactating women. Read more about this study
- Who is it for?
- Ages 25 to 30 years, women only
- Conditions the study is for
- Physical Therapy, Electrotherapy, Dietary Modification
- What is being tested?
- Electrotherapy using Chattanooga stimulation unit and Balanced Diet using domperidone drug, iron, and folic acid supplementation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Postpartum haemorrhage.
- Cardiorespiratory disease.
- Diabetes mellitus.
- Breast cancer.
- Previous surgeries in the chest, breast, or the surrounding area.
- Anemia.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ameliorative Potential of Electroacupoint for Diminutive Milk Production in Lactating Woman
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.
- Conditions
- Physical Therapy, Electrotherapy, Dietary Modification
- Being tested
- Electrotherapy using Chattanooga stimulation unit, Balanced Diet using domperidone drug, iron, and folic acid supplementation.
- Keywords
- Electroacupoint, Postnatal care, Diminutive milk production, Lactating woman
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrotherapy using Chattanooga stimulation unitProcedure or surgery
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.
Balanced Diet using domperidone drug, iron, and folic acid supplementation.Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupoint combined with postnatal care | Experimental | Electroacupoint stimulation using the Electroacupoint device and postnatal care diet in form of balanced diet and drinking sufficient clean water and routine postnatal care. Receives: Procedure: Electrotherapy using Chattanooga stimulation unit; Dietary Supplement: Balanced Diet using domperidone drug, iron, and folic acid supplementation. |
| postnatal care only | Active comparator | Postnatal care diet in form of balanced diet and drinking sufficient clean water and routine postnatal care. Receives: Dietary Supplement: Balanced Diet using domperidone drug, iron, and folic acid supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baby Weight.
Measurement of Baby Weight using the Baby Weight Scale.
Measured: Change from Baseline Baby Weight at three months.
Change in Serum Prolactin Level.
Measurement of Serum Prolactin Level using the Serum Blood Test.
Measured: Change from Baseline Serum Prolactin Level at three months.
Change in Flow of Milk.
Measurement of Flow of Milk using the Visual Analogue Scale.
Measured: Change from Baseline Flow of Milk at three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two Parallel Groups for Comparison.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haytham Ibrahim Morsi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haytham Ibrahim Morsi, Kafrelsheikh University
- Investigators
- Haytham I Morsi, M.Sc., Study director, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590805
- Sponsor's protocol ID
- P.T.1 993
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ameliorative Potential of Electroacupoint for Diminutive Milk Production in Lactating Woman
- ClinicalTrials.gov ID
- NCT06590805
- Acronym / sponsor ID
- P.T.1 993
- Conditions
- Physical Therapy, Electrotherapy, Dietary Modification
- Keywords
- Electroacupoint, Postnatal care, Diminutive milk production, Lactating woman
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Haytham Ibrahim MorsiUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to reveal the effect of electroacupoint on scanty milk production in lactating women.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two Parallel Groups for Comparison.
| Arm | Type | Receives |
|---|---|---|
| Electroacupoint combined with postnatal care | Experimental | Procedure: Electrotherapy using Chattanooga stimulation unit, Dietary Supplement: Balanced Diet using domperidone drug, iron, and folic acid supplementation.Electroacupoint stimulation using the Electroacupoint device and postnatal care diet in form of balanced diet and drinking sufficient clean water and routine postnatal care. |
| postnatal care only | Active comparator | Dietary Supplement: Balanced Diet using domperidone drug, iron, and folic acid supplementation.Postnatal care diet in form of balanced diet and drinking sufficient clean water and routine postnatal care. |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Postpartum haemorrhage.
- Cardiorespiratory disease.
- Diabetes mellitus.
- Breast cancer.
- Previous surgeries in the chest, breast, or the surrounding area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrotherapy using Chattanooga stimulation unitElectroacupoint 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. | Procedure or surgery | Electroacupoint combined with postnatal care |
| Balanced 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. | Dietary supplement | Electroacupoint combined with postnatal care, postnatal care only |
Primary outcome
Change in Baby Weight.
Time frame: Change from Baseline Baby Weight at three months.
Measurement of Baby Weight using the Baby Weight Scale.
Change in Serum Prolactin Level.
Time frame: Change from Baseline Serum Prolactin Level at three months.
Measurement of Serum Prolactin Level using the Serum Blood Test.
Change in Flow of Milk.
Time frame: Change from Baseline Flow of Milk at three months.
Measurement of Flow of Milk using the Visual Analogue Scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haytham I Morsi, M.Sc. study director
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrotherapy using Chattanooga stimulation unit and Balanced Diet using domperidone drug, iron, and folic acid supplementation. in people with Physical Therapy and Electrotherapy, run by Haytham Ibrahim Morsi at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara E Seyam, B.Sc. (+201554552868, saraseyam2024@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Baby Weight. (time frame: Change from Baseline Baby Weight at three months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.