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NCT Number: NCT07017894

Applying Breast Mask Containing Cabbage Leaves Extract to Relieve Breast Discomfort in Breastfeeding Women

In this article, women were randomly assigned to the Breast Mask Containing Cabbage Leaves Extract group and Breast Mask without Cabbage Leaves Extract group, and the breast engorgement, pain, hardness, before and after each treatment were measured. At the end of the study breast mask user experience and continued breastfeeding were measured.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veterans General Hospital

Taipei, Beitou Dist, 112304, Taiwan

Location contact

Taipei Veterans General Hospital

CONTACT

About this study

Breast engorgement as the swelling and distention of breast, which is one of the most common problems often occurs 2-4 days after delivery, resulting in pain and fever, which reduces the intention of mothers to continue breastfeeding and causes to stop breastfeeding in the early postpartum period.

There are many conservative treatments for relieving breast engorgement. At present, there have been published studies on the application of medications, cold compresses, warm compresses, massages, gua sha and cabbage leaves compression to breast problems during lactation. Previous studies have shown that cabbage leaves compression can relieve the breast engorgement, pain, and hardness of postpartum women. However, safety concerns related to freshness, preservation, and residual pesticides must be considered when using cabbage leaves in a clinical setting. The purpose of this study was to examine whether breast mask containing cabbage leaves extract can improve breast engorgement, pain, and hardness.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years old.
  • Breastfeeding.
  • Physiological breast swelling, breast heaviness, lumps, milk plugging, breast pain after childbirth.
  • Able to read and understand Chinese.

Exclusion criteria

  • Stillbirth
  • Allergy to cabbage or sulfa.
  • lactation inhibitors agents used.
  • Fever symptoms (> 38 degrees Celsius), including: wound infection, upper respiratory tract infection, urinary tract infection.
  • Breast symptoms, including: nipple cracks, skin damage, breast abscesses, mastitis, Malignant tumors.
  • Postpartum complications, including: postpartum hemorrhage, amniotic fluid embolism or other diseases requiring close care.

Treatment and study plan

Experimental: breast mask containing cabbage leaves extract group

Combination Product

apply breast mask to the breasts, avoiding the nipples, for 20 minutes, 2 times a day, for 3 days

Sham Comparator

Combination Product

Apply a breast mask without cabbage leaves extract to the breasts, avoiding the nipples, for 20 minutes, 2 times a day, for 3 days.

Primary outcomes

  1. Breast engorgement_self-rating scale

    Time frame: Day1, 2, 3

    Total four items of breast engorgement, pain, hardness, and heat. There are eleven grades, a score of 0 represents no problem at all, and a score of 10 represents the most severe degree.

  2. Breast hardness_Physiological measurements

    Time frame: Day1,2,3.

    NEUTONE TDM-Z2 durometer pressure gauge

Secondary outcomes

  1. Breast mask user experience

    Time frame: Day 3

    Does Pleura fit your needs? Pleural comfort level? Purchase intention? Recommend others to buy? How much would you consider buying it at?

  2. Continued breastfeeding

    Time frame: Day 30

    Total five items. There are five items of Exclusive breastfeeding/breastfeeding, Exclusive breastfeeding/bottle feeding, Exclusive breastfeeding/breastfeeding and bottle feeding, Mixed feeding, Feeding formula.

Study contacts

Contact information is provided by the study sponsor or research team.

Shu Chen Liao

CONTACT

[email protected]

+886228712121 ext. 82003

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Collaborators

  • National Yang Ming Chiao Tung University

Registry information

Official study title

Applying Breast Mask Containing Cabbage Leaves Extract to Relieve Breast Discomfort in Breastfeeding Women:A Double-blind Randomized Controlled Trial

Acronym: BMCCLE

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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