Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

June 3, 2020 updated by: dr. Diana Oei, Indonesia University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastmilk Volume
Time Frame: Day 7 of acupuncture or sham treatment
Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump
Day 7 of acupuncture or sham treatment
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
Day 10 of acupuncture or sham treatment (Day 3 after press tack needles were removed)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2019

Primary Completion (Actual)

February 18, 2020

Study Completion (Actual)

February 18, 2020

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medical Acupuncture 2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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