Lactation; Insufficient, PartialNCT04416880
Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency
A study testing Press Tack Needle Acupuncture in people with Lactation; Insufficient, Partial and Hypogalactia, Without Mention of Attachment Difficulty, run by Universitas Indonesia at 3 sites in Indonesia.
Trial summary
This study was meant to see the effectiveness of press tack needle acupuncture in improving lactation insufficiency. The acupuncture points used in this study were CV17 Danzhong and SI1 Shaoze. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Lactation; Insufficient, Partial, Hypogalactia, Without Mention of Attachment Difficulty
- What is being tested?
- Press Tack Needle Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesIndonesia
- Study dates
- 13 Dec 2019to 18 Feb 2020
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Breastfeeding mother who suffers from lactation insufficiency
- Breastfeeding mother from 2 weeks to 5 months post-partum
- Breastfeeding mother with healthy baby
Who cannot join
- Subject consumes drugs that are known to decrease breastmilk production
- Subject with infection or inflammation in the intended acupuncture points
- Subject with bleeding disorder
- Subject consumes anticoagulant
- Subject with known diabetic history
- Subject with body temperature > 38 degree celcius
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Puskesmas Kecamatan Menteng
Jakarta Pusat, DKI Jakarta, 10310
Poliklinik Akupunktur Medik RSCM
Jakarta Pusat, DKI Jakarta, 10430
Puskesmas Kelurahan Pegangsaan
Jakarta Pusat, DKI Jakarta, 13150
About this study
This study was meant to see the effectiveness of press tack needle acupuncture in improving lactation insufficiency. The acupuncture points used in this study were CV17 Danzhong and SI1 Shaoze. Press Tack Needles were placed in these acupuncture points for 7 days in hope that it will give continuous acupuncture stimulation that might help in improving lactation insufficiency with minimal side effect, less time consuming, and more efficient for the patient.
- Being tested
- Press Tack Needle Acupuncture
- Keywords
- acupuncture, exclusive breastfeeding, breastmilk, press tack needle, lactation insufficiency
- Medical subject headings
- Breast Feeding, Lactation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Press Tack Needle AcupunctureDevice
Seirin Pyonex Press Tack Needle 0.20 x 0.60 mm for SI1 Shaoze acupuncture point Seirin Pyonex Press Tack Needle 0.20 x 0.90 mm for CV17 Danzhong acupuncture point
| Study group | Role | What they receive |
|---|---|---|
| Press Tack Needle Acupuncture | Experimental | Patients in this group were given seirin pyonex press tack needle treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days. Receives: Device: Press Tack Needle Acupuncture |
| Sham Control Press Tack Needle Acupuncture | Sham comparator | Patients in this group were given sham treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days. Receives: Device: Press Tack Needle Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastmilk Volume
Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump
Measured: Day 7 of acupuncture or sham treatment
Breastmilk Volume
Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump
Measured: Day 10 of acupuncture or sham treatment (Day 3 after press tack needles were removed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start13 Dec 2019
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactation; Insufficient, PartialStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Diana Oei, Universitas Indonesia
- Investigators
- Diana Oei, MD, Principal investigator, Faculty of Medicine University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416880
- Sponsor's protocol ID
- Medical Acupuncture 2019
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency
- ClinicalTrials.gov ID
- NCT04416880
- Acronym / sponsor ID
- Medical Acupuncture 2019
- Keywords
- acupuncture, exclusive breastfeeding, breastmilk, press tack needle, lactation insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 4 Jun 2020 (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.
This study was meant to see the effectiveness of press tack needle acupuncture in improving lactation insufficiency. The acupuncture points used in this study were CV17 Danzhong and SI1 Shaoze. Press Tack Needles were placed in these acupuncture points for 7 days in hope that it will give continuous acupuncture stimulation that might help in improving lactation insufficiency with minimal side effect, less time consuming, and more efficient for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Press Tack Needle Acupuncture | Experimental | Device: Press Tack Needle AcupuncturePatients in this group were given seirin pyonex press tack needle treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days. |
| Sham Control Press Tack Needle Acupuncture | Sham comparator | Device: Press Tack Needle AcupuncturePatients in this group were given sham treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Breastfeeding mother who suffers from lactation insufficiency
- Breastfeeding mother from 2 weeks to 5 months post-partum
- Breastfeeding mother with healthy baby
Key exclusion criteria (6 listed)
- Subject consumes drugs that are known to decrease breastmilk production
- Subject with infection or inflammation in the intended acupuncture points
- Subject with bleeding disorder
- Subject consumes anticoagulant
- Subject with known diabetic history
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 |
|---|---|---|
| Press Tack Needle AcupunctureSeirin Pyonex Press Tack Needle 0.20 x 0.60 mm for SI1 Shaoze acupuncture point Seirin Pyonex Press Tack Needle 0.20 x 0.90 mm for CV17 Danzhong acupuncture point | Device | Press Tack Needle Acupuncture, Sham Control Press Tack Needle Acupuncture |
Primary outcome
Breastmilk Volume
Time frame: Day 7 of acupuncture or sham treatment
Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump
Breastmilk Volume
Time frame: Day 10 of acupuncture or sham treatment (Day 3 after press tack needles were removed)
Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: Yes
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Recruiting
Sodium Awareness in Lactation Trial
Breastfeeding, Preterm Birth
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.
Diana Oei, MD principal investigator
Faculty of Medicine University of Indonesia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Press Tack Needle Acupuncture in people with Lactation; Insufficient, Partial and Hypogalactia, Without Mention of Attachment Difficulty, run by Universitas Indonesia at 3 sites in Indonesia.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastmilk Volume (time frame: Day 7 of acupuncture or sham treatment). The study lists 2 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 5 Jun 2020.