• Background: Acute mastitis influences the health condition and quality of life of the infants and mothers during the lactation. Pugongying (a kind of Chinese patent medicine, Herba Taraxaci) has shown benefits in lactating women with acute mastitis in clinical practice. However, there is no solid evidence to support its effectiveness and safety.
• Methods: A three-arm, multicenter, randomized, active-controlled, outcome assessor-blinded clinical trial will be undergoing in three hospitals in Beijing. 306 participants will be randomly assigned into three groups in 1:1:1 ratio with Pugongying alone, cefdinir alone, and combination of Pugongying and cefdinir for 3-day intervention drugs administration. And in combination of Pugongying and cefdinir group, the participants will be administrated with 2-day cefdinir and 3-day Pugongying. The primary outcomes are resolution of fever, visual analogue scale (VAS) scores of breast pain, and the size of the breast mass by palpation. The secondary outcomes are the patency of milk, Traditional Chinese Medicine (TCM) symptoms scores, white blood cell count, the percentage of neutrophil and C-reactive protein, relapse at 3th day of follow up after completion of treatment, and safety assessment including routine blood, liver and renal function and electrocardiography. Besides, the incidence of surgery and the quantity of additional intervention drugs will also be evaluated.
• Discussion: The results of this trial are expected to confirm whether Chinese herbal medicine Pugongying could alleviate the symptoms and signs in lactating women with acute mastitis, and they could reduce application of cefdinir in clinical practice.
• Trial registration: ClinicalTrials.gov [Home - ClinicalTrials.gov], ID: NCT03756324. Registered on December 18th 2018. https://www.clinicaltrials.gov/ct2/show/NCT03756324?cond=Acute+mastitis&draw=2&rank=1