NCT03756324

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

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.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Beijing University of Chinese Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mastitis Acute Female

Interventions

Type	Name	Description
DRUG	CHPM (Chinese Herbal Patent Medicine )	Pugongying (Herba Taraxaci) granules is named as Pugongying Granules in China and produced by Kunming pharmaceutical factory co. LTD. The form is granules, and the participants will take the medicine after dissolved as 15g/tid for 3 days, and the investigators will follow them up for 7 days when the participants are stopped administrating.
DRUG	Antibiotics Cefdinir Capsules	Cefdinir Capsules is also named as Cefdinir and produced by Astellas Pharma Inc. The form is capsule, and participants will take orally the capsules with water as 0.1g/tid for 3 days, and the investigators will follow them up for 7 days when the participants are stopped administrating.
BEHAVIORAL	Education	Doctors will give suggestions and the medical orders to all participants, including dietary, emotional regulation and the knowledge of breast-feeding.
DRUG	Antibiotics Cefdinir Capsules	Cefdinir Capsules is also named as Cefdinir and produced by Astellas Pharma Inc. The form is capsule, and participants will take orally the capsules with water as 0.1g/tid for 2 days, and the investigators will follow them up for 7 days when the participants are stopped administrating.

Timeline

• Start date: 2018-12-20
• Primary completion: 2020-12-31
• Completion: 2021-03-31
• First posted: 2018-11-28
• Last updated: 2020-07-07

Locations

3 sites across 1 country: China