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.

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.

Study Overview

• Status: Unknown
• Conditions: Mastitis Acute Female
• Intervention / Treatment: Drug: CHPM (Chinese Herbal Patent Medicine ); Behavioral: Education; Drug: Antibiotics Cefdinir Capsules; Drug: Antibiotics Cefdinir Capsules

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.

• Study Type: Interventional
• Enrollment (Anticipated): 306
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Hospital of Traditional Chinese Medicine
    • Contact: Dongxiao Zhang; Email: Morningdong@163.com
  • Beijing, China
    • Recruiting
    • Beijing University of Chinese Medicine Third Affiliated Hospital
    • Contact: Xiaohua Pei; Phone Number: 0086-10-52075224; Email: pxh_127@163.com
    • Contact: Xinyan Jin; Phone Number: 0086-10-52075224; Email: 20170941260@bucm.edu.cn
  • Beijing, China
    • Recruiting
    • Tongzhou Maternal & Child Health Hospital of Beijing
    • Contact: Lihui Shi; Phone Number: 0086-10-81580191; Email: sup118@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Pugongying (Herba Taraxaci) Granules; Behavioral: Education; Doctors will give suggestions and the medical orders to all participants, including dietary, emotional regulation and the knowledge of breast-feeding.; Other Names: Basic medical order; Medical order
Experimental: 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.	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.; Other Names: Pugongying (Herba Taraxaci) Granules; Behavioral: Education; Doctors will give suggestions and the medical orders to all participants, including dietary, emotional regulation and the knowledge of breast-feeding.; Other Names: Basic medical order; Medical order; 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.; Other Names: Cefdinir Capsules of "normal course group"; 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.; Other Names: Cefdinir Capsules of "short course group"
Active Comparator: Antibiotics Cefdinir Capsules; Antibiotics: Cefdinir Capsules, 0.1g/tid for 3 days, follow-up for 7 days. Education, basic medical order.	Behavioral: Education; Doctors will give suggestions and the medical orders to all participants, including dietary, emotional regulation and the knowledge of breast-feeding.; Other Names: Basic medical order; Medical order; 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.; Other Names: Cefdinir Capsules of "normal course group"; 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.; Other Names: Cefdinir Capsules of "short course group"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of fever-relief	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.	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.
Change of the sores of breast pain	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.	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.
Change of the area of the breast masses	The masses are manual outlined by the outcome assessor. To evaluate the changing from the baseline to the end of 3-day treatment.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The patency of milk	The 0-3 scores are used to describe the patency of milk from no stagnation to severe stagnation. 0 indicates that there is no stagnation with breast and milk spurts out by slightly pressure; 1 indicates mild stagnation and milk flows by more pressure; 2 indicates moderate stagnation and milk drops out by much more pressure; 3 indicates there is severe stagnation and no milk excreted. The outcome will be measured by the outcome assessor. To evaluate the changing from the baseline to the end of 3-day treatment.	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.
The scores of Traditional Chinese Medicine (TCM) symptoms	The assessment criteria refer to Standard of diagnosis and treatment in TCM symptoms (2016 version, released by State Administration of Traditional Chinese Medicine of the People's Republic of China). The outcome is specifically used to assess the holistic physical status of the participants and will be measured by TCM practitioners. To evaluate the changing from the baseline to the end of 3-day treatment.	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 White blood cell count	Measured by the routine blood test. To evaluate the changing from the baseline to the end of 3-day treatment.	Routine blood test will be tested and analyzed by laboratory at the beginning since enrolling and after 3-day treatment.
Change of the percentage of neutrophil	Measured by the routine blood test. To evaluate the changing from the baseline to the end of 3-day treatment.	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.	Measured by the routine blood test. To evaluate the changing from the baseline to the end of 3-day treatment.	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	Adverse events are assessed by CTCAE (version 5.0, released by NIH and NIC). The outcomes measured at baseline are used to determine whether the participants are eligible to participate the study and the outcomes measured during and after 3-day treatment are used to assess the safety of the intervention medicine and to protect the rights of the participants. To focus on (1) allergic reaction; (2) the vital signs: resting heart rate in times/minutes, respiratory rate in times/minutes and blood pressure in mmHg; (3) laboratory test: urinalysis (LEU, BLO, KET, NIH, GLU, PRO, UBG, SG) in positive/negative, stool routine (Sed occult blood) in postive/negative, electrocardiogram in normal/abnormal, liver function test (AST, ALT, TBIL, DBIL, TG, GLU) in positive/negative and renal function test (CR, UA, UREA) in positive/negative. To observe the incidence of the 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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of acute mastitis relapse in 3-day follow-up	After 3-day treatment, the participants will be followed up for 3 days to figure out the incidence of acute mastitis relapse. The investigators will call the participants to inquiry their conditions (body temperature, breast pain, amount of milk).	After 3-day treatment, the participants will be called each day to answer the questions from the investigators, lasting for 3 days.
The indidence of surgery	After 3-day treatment, clinical evaluation will be conducted by doctors. If B-ultrasound shows there is mammary abscess, the doctor will perform surgery based on liquefaction and size of the abscess.	Clinical evaluation will be conducted after 3-day treatment.
The quantity of additional intervention medicine administration	After 3-day treatment, clinical evaluation will be conducted by doctors. If B-ultrasound shows there is mammary abscess, the doctor will prescribe Cefdinir or Pugongying granules based on liquefaction and size of the abscess.	Clinical evaluation will be conducted after 3-day treatment.

Collaborators and Investigators

• Sponsor: Beijing University of Chinese Medicine
• Collaborators: Beijing Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: Xiaohua Pei, MD, Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: November 18, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Antibiotics; Postpartum; Cephalosporin; Traditional Chinese medicine; Lactation; Breastfeeding; multicenter; Cefdinir; Pugongying; Herba Taraxaci; Acute Mastitis; Chinese herb
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Pregnancy Complications; Puerperal Disorders; Mastitis; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefdinir
• Other Study ID Numbers: CFH2018-7032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No