Status:
UNKNOWN
The Effect of Chinese Herbal Medicine for Reducing the Application of Antibiotics in the Treatment of Acute Mastitis
Lead Sponsor:
Beijing University of Chinese Medicine
Collaborating Sponsors:
Beijing Hospital of Traditional Chinese Medicine
Conditions:
Mastitis Acute Female
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The object of the study is to evaluate the effect of Pugongying (Herba Taraxaci) Granules to reduce the application of antibiotics for women with acute mastitis.
Detailed Description
Acute mastitis affects the health and quality of life of the infants and mothers during the lactation. Increasing studies indicate that bacterial infections and/or dysbacteriosis are essential to the ...
Eligibility Criteria
Inclusion
- Women in lactation who have strong willing to breastfeeding;
- The course of acute mastitis should be within 3 days, and the ultrasound examination indicates there is no abscess cavity formed;
- The body temperature is higher than 37.2°C but lower than 41°C;
- The VAS scores of participants≥4;
- Patients with acute mastitis have not received other medical therapies;
- Those who have signed informed consent.
Exclusion
- Participants who suffered nipple ulceration, painful fissuring or developmental defects fail to breastfeed;
- Participants with other breast diseases are not appropriate to breastfeed;
- Participants with severe cognitive or metabolic diseases will affect breastfeeding;
- Participants who have been allergic to penicillin and cephalosporin.
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT03756324
Start Date
December 20 2018
End Date
March 31 2021
Last Update
July 7 2020
Active Locations (3)
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1
Beijing Hospital of Traditional Chinese Medicine
Beijing, China
2
Beijing University of Chinese Medicine Third Affiliated Hospital
Beijing, China
3
Tongzhou Maternal & Child Health Hospital of Beijing
Beijing, China