CClinicalTrials.gg
CompletedNCT04416880Updated Jun 5, 2020

Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

An interventional study of Press Tack Needle Acupuncture in Lactation; Insufficient, Partial and Hypogalactia, Without Mention of Attachment Difficulty, sponsored by Indonesia University. Completed at 3 sites in Indonesia. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-06-05.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Dec 2019, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Lactation; Insufficient, Partial
  • Hypogalactia, Without Mention of Attachment Difficulty

Keywords

  • acupuncture
  • exclusive breastfeeding
  • breastmilk
  • press tack needle
  • lactation insufficiency
03

In context

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Breastfeeding mother who suffers from lactation insufficiency
  • Breastfeeding mother from 2 weeks to 5 months post-partum
  • Breastfeeding mother with healthy baby

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Press Tack Needle Acupuncture

    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.

    Device: Press Tack Needle Acupuncture

  • Sham comparator
    Sham Control Press Tack Needle Acupuncture

    Patients in this group were given sham treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days.

    Device: Press Tack Needle Acupuncture

Interventions

  • DevicePress Tack Needle Acupuncture

    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

06

What researchers measure

Primary outcomes

  1. Breastmilk Volume

    Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump

    Time frame: Day 7 of acupuncture or sham treatment

  2. Breastmilk Volume

    Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump

    Time frame: Day 10 of acupuncture or sham treatment (Day 3 after press tack needles were removed)

07

Study locations

3 sites
  • Puskesmas Kecamatan Menteng
    Jakarta Pusat, DKI Jakarta 10310, Indonesia
  • Poliklinik Akupunktur Medik RSCM
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
  • Puskesmas Kelurahan Pegangsaan
    Jakarta Pusat, DKI Jakarta 13150, Indonesia
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr

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 Jun 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04416880
Lead sponsor
Indonesia University
Responsible party
dr. Diana Oei (Principal Investigator, Indonesia University) — Principal investigator
First posted
Jun 4, 2020
Start date
Dec 13, 2019
Primary completion
Feb 18, 2020
Completion
Feb 18, 2020
Last update
Jun 5, 2020

Study contacts

Diana Oei, MD
principal investigator · Faculty of Medicine University of Indonesia

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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