Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

Hypogalactia, Without Mention of Attachment Difficulty Clinical Trial

Official title:

Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416880
• Other study ID #: Medical Acupuncture 2019
• Status: Completed
• Phase: N/A
• Start date: December 13, 2019
• Est. completion date: February 18, 2020

Study information

• Verified date: June 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 18, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogalactia, Without Mention of Attachment Difficulty
• Lactation Disorders
• Lactation; Insufficient, Partial

Intervention

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

Locations

Country	Name	City	State
Indonesia	Poliklinik Akupunktur Medik RSCM	Jakarta Pusat	DKI Jakarta
Indonesia	Puskesmas Kecamatan Menteng	Jakarta Pusat	DKI Jakarta
Indonesia	Puskesmas Kelurahan Pegangsaan	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastmilk Volume	Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump	Day 7 of acupuncture or sham treatment
Primary	Breastmilk Volume	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)