Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04416880
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
dr. Diana Oei, Indonesia University

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
Lactation; Insufficient, Partial Hypogalactia, Without Mention of Attachment Difficulty Device: Press Tack Needle Acupuncture Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : December 13, 2019
Actual Primary Completion Date : February 18, 2020
Actual Study Completion Date : February 18, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Breastmilk Volume [ Time Frame: Day 7 of acupuncture or sham treatment ]
    Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breastfeeding mothers
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04416880


Locations
Layout table for location information
Indonesia
Puskesmas Kecamatan Menteng
Jakarta Pusat, DKI Jakarta, Indonesia, 10310
Poliklinik Akupunktur Medik RSCM
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Puskesmas Kelurahan Pegangsaan
Jakarta Pusat, DKI Jakarta, Indonesia, 13150
Sponsors and Collaborators
Indonesia University
Investigators
Layout table for investigator information
Principal Investigator: Diana Oei, MD Faculty of Medicine University of Indonesia
Layout table for additonal information
Responsible Party: dr. Diana Oei, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT04416880    
Other Study ID Numbers: Medical Acupuncture 2019
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Layout table for additional information
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, Indonesia University:
acupuncture
exclusive breastfeeding
breastmilk
press tack needle
lactation insufficiency
Additional relevant MeSH terms:
Layout table for MeSH terms
Lactation Disorders
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases