Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture for Breast Engorgement During Lactation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03230760
Recruitment Status : Unknown
Verified August 2017 by PeiJung Chiang, Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
First Posted : July 26, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
PeiJung Chiang, Taichung Veterans General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Breast engorgement which may manifest swell, throb, and cause mild to extreme pain is the common difficulty for breast feeding woman. It occurs in the mammary glands due to expansion and pressure exerted by the synthesis and storage of breast milk and it usually happens when the breasts switch from colostrums to mature milk. However, engorgement can also happen if lactating women miss several nursing and not enough milk is expressed from the breasts. It can be exacerbated by insufficient breastfeeding and/or blocked milk ducts. Engorgement may lead to mastitis and untreated engorgement puts pressure on the milk ducts, often causing a plugged duct.

According the meridian theory, the investigators propose the acupuncture treatment for patients of breast engorgement.

The investigators will include 60 patients and measure the acupuncture effect. The inclusion criteria are women with breast engorgement and 20 years old or older. Exclusion standards are patients with: 1. diabetes mellitus 2. Psychological disease or mental illness 3. Fever > 38 degrees Celsius 4. Mastitis 5.analgetics or anti - inflammatory agents used 6. ultrasound therapy applied


Condition or disease Intervention/treatment Phase
Breast Engorgement Device: acupuncture Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture for Breast Engorgement During Lactation: a Pilot Study.
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : June 26, 2018
Estimated Study Completion Date : June 26, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: treatment Device: acupuncture
Device: acupuncture Acupuncture is the treatment which balances qi and blood by inserting needles into the acupoints of the meridians in human body.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. breast engorgement [ Time Frame: 3 days ]
    Six-point Engorgement Scale


Secondary Outcome Measures :
  1. mastitis [ Time Frame: 3 days ]
    The incidence of mastitis


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women with breast engorgement and 20 years old or older

Exclusion Criteria:

  • patients with:

    1. diabetes mellitus
    2. psychological disease or mental illness
    3. Fever > 38 degrees Celsius
    4. Mastitis
    5. analgesics or anti - inflammatory agents used
    6. ultrasound therapy applied
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230760


Contacts
Layout table for location contacts
Contact: ShuHuey Chou 886963826707 lummdo@gmail.com

Locations
Layout table for location information
Taiwan
Taichung Veterans General Hospital Not yet recruiting
Taichung, Taiwan, 407
Contact: PeiJung Chiang    886963826707    aerin.chiang@gmail.com   
TCM Recruiting
Taichung, Taiwan, 407
Contact: PeiJung Chiang    886963826707      
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Layout table for investigator information
Principal Investigator: PeiJung Chiang Traditional Chinese Medicine department
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Layout table for additonal information
Responsible Party: PeiJung Chiang, physician, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT03230760    
Other Study ID Numbers: CF17141A
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PeiJung Chiang, Taichung Veterans General Hospital:
acupuncture
breast engorgement
lactation
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperemia
Vascular Diseases
Cardiovascular Diseases