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

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ClinicalTrials.gov Identifier: NCT03756324
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Beijing Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Xiaohua Pei, Beijing University of Chinese Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Mastitis Acute Female Drug: CHPM (Chinese Herbal Patent Medicine ) Drug: Antibiotics Cefdinir Capsules Behavioral: Education Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Based on previous studies, considering the 20% expulsion rate, the investigators plan to recruit 306 participants with sample-size calculation formula. The sequence of randomization (1:1:1) will be generated by the statisticians with a computer program.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
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.
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cefdinir

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 Name: 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 Name: 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 2 days, and the investigators will follow them up for 7 days when the participants are stopped administrating.
Other Name: 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.

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 Name: Cefdinir Capsules of "normal course group"

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




Primary Outcome Measures :
  1. Change of fever-relief [ Time Frame: 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.


  2. Change of the sores of breast pain [ Time Frame: 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.


  3. Change of the area of the breast masses [ Time Frame: 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.



Secondary Outcome Measures :
  1. The patency of milk [ Time Frame: 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 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.


  2. The scores of Traditional Chinese Medicine (TCM) symptoms [ Time Frame: Measured from the beginning to the end of the treatment, once a day for 3 days, total 4 times including the baseline measured. ]

    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.


  3. Change of the White blood cell count [ Time Frame: Routine blood test will be tested and analyzed by laboratory at the beginning since enrolling and after 3-day treatment. ]

    Measured by the routine blood test.

    To evaluate the changing from the baseline to the end of 3-day treatment.


  4. Change of the percentage of neutrophil [ Time Frame: Routine blood test will be tested and analyzed by laboratory at the beginning since enrolling and after 3-day treatment. ]

    Measured by the routine blood test.

    To evaluate the changing from the baseline to the end of 3-day treatment.


  5. Change of the C-reactive protein. [ Time Frame: Routine blood test will be tested and analyzed by laboratory at the beginning since enrolling and after 3-day treatment. ]

    Measured by the routine blood test.

    To evaluate the changing from the baseline to the end of 3-day treatment.


  6. Number of participants with treatment-related adverse events [ Time Frame: 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. ]

    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.



Other Outcome Measures:
  1. The incidence of acute mastitis relapse in 7-day follow-up [ Time Frame: After 3-day treatment, the participants will be called each day to answer the questions from the investigators, lasting for 7 days. ]
    After 3-day treatment, the participants will be followed up for 7 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).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756324


Contacts
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Contact: Xiaohua Pei, MD 0086-10-52075224 pxh_127@163.com
Contact: Xinyan Jin 0086-10-52075224 ext 8613001144056 20170941260@bucm.edu.cn

Locations
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China
Beijing Hospital of Traditional Chinese Medicine Recruiting
Beijing, China
Contact: Dongxiao Zhang       Morningdong@163.com   
Beijing University of Chinese Medicine Third Affiliated Hospital Recruiting
Beijing, China
Contact: Xiaohua Pei    0086-10-52075224    pxh_127@163.com   
Contact: Xinyan Jin    0086-10-52075224    20170941260@bucm.edu.cn   
Tongzhou Maternal & Child Health Hospital of Beijing Recruiting
Beijing, China
Contact: Lihui Shi    0086-10-81580191    sup118@aliyun.com   
Sponsors and Collaborators
Beijing University of Chinese Medicine
Beijing Hospital of Traditional Chinese Medicine
Investigators
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Principal Investigator: Xiaohua Pei, MD Beijing University of Chinese Medicine

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Responsible Party: Xiaohua Pei, Principal Investigator, Clinical Professor, Academic Leader of Breast Disease in Traditional Chinese Medicine., Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT03756324     History of Changes
Other Study ID Numbers: CFH2018-7032
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiaohua Pei, Beijing University of Chinese Medicine:
Cefdinir
Pugongying
Herba Taraxaci
Acute Mastitis
Randomized controlled trial
Postpartum
Breastfeeding
Lactation
multicenter
Chinese herb
Traditional Chinese medicine
Cephalosporin
Antibiotics

Additional relevant MeSH terms:
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Mastitis
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases
Anti-Bacterial Agents
Cefdinir
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents