Acupuncture for Breast Engorgement During Lactation

NCT ID: NCT03230760

Last Updated: 2017-08-02

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-18

Study Completion Date

2018-06-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Engorgement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

treatment

Group Type EXPERIMENTAL

acupuncture

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

acupuncture

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

PeiJung Chiang

physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

PeiJung Chiang

Role: PRINCIPAL_INVESTIGATOR

Traditional Chinese Medicine department

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status NOT_YET_RECRUITING

TCM

Taichung, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

ShuHuey Chou

Role: CONTACT

886963826707

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

PeiJung Chiang

Role: primary

886963826707

PeiJung Chiang

Role: primary

886963826707

References

Explore related publications, articles, or registry entries linked to this study.

Mangesi L, Zakarija-Grkovic I. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2016 Jun 28;2016(6):CD006946. doi: 10.1002/14651858.CD006946.pub3.

Reference Type RESULT
PMID: 27351423 (View on PubMed)

Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.

Reference Type DERIVED
PMID: 32987448 (View on PubMed)

Zakarija-Grkovic I, Stewart F. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2020 Sep 18;9(9):CD006946. doi: 10.1002/14651858.CD006946.pub4.

Reference Type DERIVED
PMID: 32944940 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CF17141A

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.