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

NCT03756324 | Unknown Phase 2 DMC

• 1 other identifier: CFH2018-7032
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 3

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.

Conditions

Mastitis Acute Female

Keywords

Pugongying; Herba Taraxaci; Acute Mastitis; Cefdinir; Randomized controlled trial; Postpartum; Breastfeeding; Lactation; multicenter; Chinese herb; Traditional Chinese medicine; Cephalosporin; Antibiotics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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.

• 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.

• 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.

• 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.

Other Outcomes (3)

• The incidence of acute mastitis relapse in 3-day follow-up

  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

  Clinical evaluation will be conducted after 3-day treatment.

• The quantity of additional intervention medicine administration

  Clinical evaluation will be conducted after 3-day treatment.

Study Arms (3)

CHPM (Chinese Herbal Patent Medicine )

EXPERIMENTAL

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 ); Behavioral: Education

CHPM & Antibiotics Cefdinir Capsules

EXPERIMENTAL

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 ); Behavioral: Education; Drug: Antibiotics Cefdinir Capsules

Antibiotics Cefdinir Capsules

ACTIVE COMPARATOR

Antibiotics: Cefdinir Capsules, 0.1g/tid for 3 days, follow-up for 7 days. Education, basic medical order.

Drug: Antibiotics Cefdinir Capsules; Behavioral: Education

Interventions

CHPM (Chinese Herbal Patent Medicine ) DRUG

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.

Also known as: Pugongying (Herba Taraxaci) Granules

CHPM & Antibiotics Cefdinir Capsules; CHPM (Chinese Herbal Patent Medicine )

Antibiotics Cefdinir Capsules DRUG

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.

Also known as: Cefdinir Capsules of "normal course group"

Antibiotics Cefdinir Capsules

Education BEHAVIORAL

Doctors will give suggestions and the medical orders to all participants, including dietary, emotional regulation and the knowledge of breast-feeding.

Also known as: Basic medical order, Medical order

Antibiotics Cefdinir Capsules; CHPM & Antibiotics Cefdinir Capsules; CHPM (Chinese Herbal Patent Medicine )

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead
• Beijing Hospital of Traditional Chinese Medicine: collaborator

Study Sites (3)

Beijing Hospital of Traditional Chinese Medicine

Beijing, China

RECRUITING

Beijing University of Chinese Medicine Third Affiliated Hospital

Beijing, China

RECRUITING

Tongzhou Maternal & Child Health Hospital of Beijing

Beijing, China

RECRUITING

Related Publications (1)

• Jin X, Xiao J, Lu C, Ma W, Fan Y, Xue X, Xia Y, Chen N, Liu J, Pei X. Breastmilk microbiome changes associated with lactational mastitis and treatment with dandelion extract. Front Microbiol. 2023 Nov 13;14:1247868. doi: 10.3389/fmicb.2023.1247868. eCollection 2023.

  PMID: 38029215 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Cefdinir; Educational Status; Medical Order Entry Systems

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Socioeconomic Factors; Population Characteristics; Hospital Information Systems; Hospital Administration; Health Facility Administration; Organization and Administration; Health Services Administration; Management Information Systems; Medical Records Systems, Computerized; Medical Records; Records

Study Officials

• Xiaohua Pei, MD

  Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohua Pei, MD

CONTACT

0086-10-52075224; pxh_127@163.com

Xinyan Jin

CONTACT

0086-10-52075224; 20170941260@bucm.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor, Academic Leader of Breast Disease in Traditional Chinese Medicine.

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: November 28, 2018
• Study Start: December 20, 2018
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)