Acupuncture for Breast Engorgement During Lactation
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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
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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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
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 |

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. |
- breast engorgement [ Time Frame: 3 days ]Six-point Engorgement Scale
- mastitis [ Time Frame: 3 days ]The incidence of mastitis

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- women with breast engorgement and 20 years old or older
Exclusion Criteria:
-
patients with:
- diabetes mellitus
- psychological disease or mental illness
- Fever > 38 degrees Celsius
- Mastitis
- analgesics or anti - inflammatory agents used
- ultrasound therapy applied

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
Contact: ShuHuey Chou | 886963826707 | lummdo@gmail.com |
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 |
Principal Investigator: | PeiJung Chiang | Traditional Chinese Medicine department |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
acupuncture breast engorgement lactation |
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