Clinical trial NCT03756324: The Effect of Chinese Herbal Medicine for Reducing the Application of Antibiotics in the Treatment of Acute Mastitis
Official title: The Effect of Chinese Herbal Medicine for Reducing the Application of Antibiotics in the Treatment of Acute Mastitis With Three Groups in Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Mastitis Acute Female
Keywords: Pugongying
Herba Taraxaci
Acute Mastitis
Cefdinir
Randomized controlled trial
Postpartum
Breastfeeding
Lactation
multicenter
Chinese herb
Traditional Chinese medicine
Cephalosporin
Antibiotics
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Beijing Hospital of Traditional Chinese Medicine
First posted: 2018-11-28
Enrollment: 306
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Based on previous studies, considering the 20% expulsion rate, the investigators plan to recruit 306 participants with sample-size calculation formula. The sequence of randomization (1:1:1) will be generated by the statisticians with a computer program.
Primary purpose: TREATMENT

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 mechanisms of the disease. Thus, antibiotics is widely used in clinical practice, especially cephalosporin in China. However, mistaking antibiotic will affect the physical function, even mothers' breastfeeding. The previous clinical trial that the investigators had conducted in the Third affiliated hospital of Beijing University of Chinese Medicine, has demonstrated that Chinese herbal medicine can act better than Cefdinir in the fever-relief time and breast pain scores. Some studies the investigators searched in the databases have showed that Pugongying (Herba Taraxaci) has a broad spectrum of antimicrobial activity, and it can regulate dysbacteriosis. At the same time, Pugongying (Herba Taraxaci) can also promote the secretion of milk and maintain the patency of milk well. The main ingredient of Pugongying (Herba Taraxaci) Granules is Pugongying herbs (Herba Taraxaci). Pugongying (Herba Taraxaci) Granules is approved by China Food and Drug Administration (CFDA) to treat acute mastitis. Although Pugongying (Herba Taraxaci) Granules is widely used in clinical practice, there is no trial to test the efficacy of Pugongying (Herba Taraxaci) for women with acute mastitis. Therefore, the investigators set three groups with Pugongying (Herba Taraxaci) Granules alone, Cefdinir alone and combination of Pugongying (Herba Taraxaci) Granules and Cefdinir.

Eligibility criteria: Inclusion Criteria:

1. Women in lactation who have strong willing to breastfeeding;
2. The course of acute mastitis should be within 3 days, and the ultrasound examination indicates there is no abscess cavity formed;
3. The body temperature is higher than 37.2°C but lower than 41°C;
4. The VAS scores of participants≥4;
5. Patients with acute mastitis have not received other medical therapies;
6. Those who have signed informed consent.

Exclusion Criteria:

1. Participants who suffered nipple ulceration, painful fissuring or developmental defects fail to breastfeed;
2. Participants with other breast diseases are not appropriate to breastfeed;
3. Participants with severe cognitive or metabolic diseases will affect breastfeeding;
4. Participants who have been allergic to penicillin and cephalosporin.

Primary outcomes:
measure: Change of fever-relief
timeFrame: Measured from the beginning to the end of the treatment, every 4 hours for 3 days, total 19 times including the baseline measured, specifically on 2:00 am, 6:00 am, 10:00 am, 14:00 pm, 18:00 pm, 22:00 pm.
measure: Change of the sores of breast pain
timeFrame: Measured from the beginning to the end of the treatment, every 8 hours for 3 days, total 10 times including the baseline measured, specifically measured on 6:00 am, 14:00 pm, 22:00 pm.
measure: Change of the area of the breast masses
timeFrame: The masses will be measured from the beginning to the end of the treatment, once a day for 3 days, and recorded with a camera, total 4 times including the baseline measured.
Secondary outcomes:
measure: The patency of milk
timeFrame: The outcome will be measured from the beginning to the end of the treatment, once a day for 3 days, total 4 times including the baseline measured.
measure: The scores of Traditional Chinese Medicine (TCM) symptoms
timeFrame: Measured from the beginning to the end of the treatment, once a day for 3 days, total 4 times including the baseline measured.
measure: Change of the White blood cell count
timeFrame: Routine blood test will be tested and analyzed by laboratory at the beginning since enrolling and after 3-day treatment.
measure: Change of the percentage of neutrophil
timeFrame: Routine blood test will be tested and analyzed by laboratory at the beginning since enrolling and after 3-day treatment.
measure: Change of the C-reactive protein.
timeFrame: Routine blood test will be tested and analyzed by laboratory at the beginning since enrolling and after 3-day treatment.
measure: Number of participants with treatment-related adverse events
timeFrame: Symptoms of allergic reaction will be observed at any time. Signs examination will be taken once a day, for 3 days, total 4 times including the baseline measured. Laboratory test will be taken at the beginning since enrolling and after 3-day treatment.
Other outcomes:
measure: The incidence of acute mastitis relapse in 3-day follow-up
timeFrame: After 3-day treatment, the participants will be called each day to answer the questions from the investigators, lasting for 3 days.
measure: The indidence of surgery
timeFrame: Clinical evaluation will be conducted after 3-day treatment.
measure: The quantity of additional intervention medicine administration
timeFrame: Clinical evaluation will be conducted after 3-day treatment.
Locations:
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine
city: Beijing
country: China
facility: Beijing University of Chinese Medicine Third Affiliated Hospital
city: Beijing
country: China
facility: Tongzhou Maternal & Child Health Hospital of Beijing
Study officials:
affiliation: Beijing University of Chinese Medicine
name: Xiaohua Pei, MD
role: PRINCIPAL_INVESTIGATOR
References: