The Effect of Chinese Herbal Medicine for Reducing the Application of Antibiotics in the Treatment of Acute Mastitis

Beijing University of Chinese Medicine

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Mastitis Acute Female

Treatments: Behavioral: Education; Drug: Antibiotics Cefdinir Capsules; Drug: CHPM (Chinese Herbal Patent Medicine )

Study type: Interventional

Funder types: Other

Identifiers

NCT03756324

CFH2018-7032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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306 participants in 3 patient groups

CHPM (Chinese Herbal Patent Medicine )

Experimental group

Description:

CHPM (Chinese Herbal Patent Medicine ): Pugongying (Herba Taraxaci) Granules, 15g/tid for 3 days, follow-up for 7 days. Education, basic medical order.

Treatment:

Drug: CHPM (Chinese Herbal Patent Medicine )

Behavioral: Education

CHPM & Antibiotics Cefdinir Capsules

Experimental group

Description:

CHPM (Chinese Herbal Patent Medicine): Pugongying (Herba Taraxaci) granules, 15g/tid for 3 days, follow-up for 7 days. Antibiotics: Cefdinir Capsules, 0.1g/tid for 2 days, follow-up for 7 days. Education, basic medical order.

Treatment:

Drug: CHPM (Chinese Herbal Patent Medicine )

Drug: Antibiotics Cefdinir Capsules

Drug: Antibiotics Cefdinir Capsules

Behavioral: Education

Antibiotics Cefdinir Capsules

Active Comparator group

Description:

Antibiotics: Cefdinir Capsules, 0.1g/tid for 3 days, follow-up for 7 days. Education, basic medical order.

Treatment:

Drug: Antibiotics Cefdinir Capsules

Drug: Antibiotics Cefdinir Capsules

Behavioral: Education