Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

NCT ID: NCT04416880

Last Updated: 2020-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-13

Study Completion Date

2020-02-18

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Press Tack Needle Acupuncture

Intervention Type DEVICE

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 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.

Group Type SHAM_COMPARATOR

Press Tack Needle Acupuncture

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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dr. Diana Oei

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diana Oei, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine University of Indonesia

Locations

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Puskesmas Kecamatan Menteng

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Poliklinik Akupunktur Medik RSCM

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Puskesmas Kelurahan Pegangsaan

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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Medical Acupuncture 2019

Identifier Type: -

Identifier Source: org_study_id

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