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

Mastitis Acute Female Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03756324
• Other study ID #: CFH2018-7032
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 20, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2020
• Source: Beijing University of Chinese Medicine
• Contact: Xiaohua Pei, MD
• Phone: 0086-10-52075224
• Email: pxh_127[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mastitis
• Mastitis Acute Female

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Hospital of Traditional Chinese Medicine	Beijing
China	Beijing University of Chinese Medicine Third Affiliated Hospital	Beijing
China	Tongzhou Maternal & Child Health Hospital of Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine	Beijing Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.