Back to resultsEffectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency
Primary Purpose
Lactation; Insufficient, Partial, Hypogalactia, Without Mention of Attachment Difficulty
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Press Tack Needle Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Lactation; Insufficient, Partial focused on measuring acupuncture, exclusive breastfeeding, breastmilk, press tack needle, lactation insufficiency
Eligibility 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
Sites / Locations
- Puskesmas Kecamatan Menteng
- Poliklinik Akupunktur Medik RSCM
- Puskesmas Kelurahan Pegangsaan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Press Tack Needle Acupuncture
Sham Control Press Tack Needle Acupuncture
Arm Description
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.
Patients in this group were given sham treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days.
Outcomes
Primary Outcome Measures
Breastmilk Volume
Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump
Breastmilk Volume
Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04416880
Brief Title
Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency
Official Title
Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
February 18, 2020 (Actual)
Study Completion Date
February 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactation; Insufficient, Partial, Hypogalactia, Without Mention of Attachment Difficulty
Keywords
acupuncture, exclusive breastfeeding, breastmilk, press tack needle, lactation insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Press Tack Needle Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Control Press Tack Needle Acupuncture
Arm Type
Sham Comparator
Arm Description
Patients in this group were given sham treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days.
Intervention Type
Device
Intervention Name(s)
Press Tack Needle Acupuncture
Intervention Description
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 Measure Information:
Title
Breastmilk Volume
Description
Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump
Time Frame
Day 7 of acupuncture or sham treatment
Title
Breastmilk Volume
Description
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)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Breastfeeding mothers
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Oei, MD
Organizational Affiliation
Faculty of Medicine University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Puskesmas Kecamatan Menteng
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10310
Country
Indonesia
Facility Name
Poliklinik Akupunktur Medik RSCM
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Facility Name
Puskesmas Kelurahan Pegangsaan
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
13150
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency
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