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.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 306
- 试验地点
- 3
- 主要终点
- Change of the area of the breast masses
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the different numbers of interventions, the investigators can not blind the participants and the doctors. Thus, the CRF recorders, outcomes assessors and the statisticians will be blinded in the study.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
CHPM (Chinese Herbal Patent Medicine )
CHPM (Chinese Herbal Patent Medicine ): Pugongying (Herba Taraxaci) Granules, 15g/tid for 3 days, follow-up for 7 days.
Education, basic medical order.
干预措施: CHPM (Chinese Herbal Patent Medicine ) (Drug)
CHPM (Chinese Herbal Patent Medicine )
CHPM (Chinese Herbal Patent Medicine ): Pugongying (Herba Taraxaci) Granules, 15g/tid for 3 days, follow-up for 7 days.
Education, basic medical order.
干预措施: Education (Behavioral)
CHPM & Antibiotics Cefdinir Capsules
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.
干预措施: CHPM (Chinese Herbal Patent Medicine ) (Drug)
CHPM & Antibiotics Cefdinir Capsules
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.
干预措施: Education (Behavioral)
CHPM & Antibiotics Cefdinir Capsules
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.
干预措施: Antibiotics Cefdinir Capsules (Drug)
Antibiotics Cefdinir Capsules
Antibiotics: Cefdinir Capsules, 0.1g/tid for 3 days, follow-up for 7 days.
Education, basic medical order.
干预措施: Antibiotics Cefdinir Capsules (Drug)
Antibiotics Cefdinir Capsules
Antibiotics: Cefdinir Capsules, 0.1g/tid for 3 days, follow-up for 7 days.
Education, basic medical order.
干预措施: Education (Behavioral)
结局指标
主要结局
Change of the area of the breast masses
时间窗: 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.
The masses are manual outlined by the outcome assessor. To evaluate the changing from the baseline to the end of 3-day treatment.
Change of the sores of breast pain
时间窗: 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.
Pain of breast will be self-reported by participants and recorded. A visual analog scale (VAS) is used to assess breast pain. The scale was tested in the investigator's previous trial. 0 score indicates "no uncomfortable feeling". 1-3 indicates "mild uncomfortable feeling". 4-6 indicates "moderate uncomfortable feeling". 7-10 indicates "severe uncomfortable feeling". To evaluate the changing from the baseline to the end of 3-day treatment.
Change of fever-relief
时间窗: 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.
Body temperature will be measured by mercury thermometer and recorded on the prepared card by participants. The temperature of the participants reduces to 37.2℃ or more below, assessing as the normal temperature. And the normal temperature last for at least 24 hours, considered as fever-relief. To evaluate the effect of drug action time and the temperature changing from the baseline to the end of 3-day treatment.
次要结局
- Change of the White blood cell count(Routine blood test will be tested and analyzed by laboratory at the beginning since enrolling and after 3-day treatment.)
- Number of participants with treatment-related adverse events(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.)
- The scores of Traditional Chinese Medicine (TCM) symptoms(Measured from the beginning to the end of the treatment, once a day for 3 days, total 4 times including the baseline measured.)
- The patency of milk(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.)
- Change of the percentage of neutrophil(Routine blood test will be tested and analyzed by laboratory at the beginning since enrolling and after 3-day treatment.)
- Change of the C-reactive protein.(Routine blood test will be tested and analyzed by laboratory at the beginning since enrolling and after 3-day treatment.)
研究者
Xiaohua Pei
Principal Investigator, Clinical Professor, Academic Leader of Breast Disease in Traditional Chinese Medicine.
Beijing University of Chinese Medicine