Clincosm LogoSign in Get a demo

Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT04416880
Collaborator
(none)
36
Enrollment
3
Locations
2
Arms
2.2
Actual Duration (Months)
12
Patients Per Site
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Press Tack Needle Acupuncture
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency
Actual Study Start Date :
Dec 13, 2019
Actual Primary Completion Date :
Feb 18, 2020
Actual Study Completion Date :
Feb 18, 2020

Arms and Interventions

Arm Intervention/Treatment
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
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
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
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

Outcome Measures

Primary Outcome Measures

  1. Breastmilk Volume [Day 7 of acupuncture or sham treatment]

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

  2. Breastmilk Volume [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Puskesmas Kecamatan Menteng Jakarta Pusat DKI Jakarta Indonesia 10310
2 Poliklinik Akupunktur Medik RSCM Jakarta Pusat DKI Jakarta Indonesia 10430
3 Puskesmas Kelurahan Pegangsaan Jakarta Pusat DKI Jakarta Indonesia 13150

Sponsors and Collaborators

  • Indonesia University

Investigators

  • Principal Investigator: Diana Oei, MD, Faculty of Medicine University of Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
dr. Diana Oei, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier:
NCT04416880
Other Study ID Numbers:
  • Medical Acupuncture 2019
First Posted:
Jun 4, 2020
Last Update Posted:
Jun 5, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by dr. Diana Oei, Principal Investigator, Indonesia University
acupuncture
exclusive breastfeeding
breastmilk
press tack needle
lactation insufficiency
Additional relevant MeSH terms:
Lactation Disorders

Study Results

No Results Posted as of Jun 5, 2020