Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: February 18, 2020

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Breastfeeding mothers

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indonesia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: dr. Diana Oei, Principal Investigator – Indonesia University
  • Overall Official(s)
    • Diana Oei, MD, Principal Investigator, Faculty of Medicine University of Indonesia

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