The Effect of Chinese Herbal Medicine for Reducing the Application of Antibiotics in the Treatment of Acute Mastitis
NCT ID: NCT03756324
Last Updated: 2020-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
306 participants
INTERVENTIONAL
2018-12-20
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Education
Doctors will give suggestions and the medical orders to all participants, including dietary, emotional regulation and the knowledge of breast-feeding.
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.
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.
Education
Doctors will give suggestions and the medical orders to all participants, including dietary, emotional regulation and the knowledge of breast-feeding.
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.
Antibiotics Cefdinir Capsules
Antibiotics: Cefdinir Capsules, 0.1g/tid for 3 days, follow-up for 7 days.
Education, basic medical order.
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.
Education
Doctors will give suggestions and the medical orders to all participants, including dietary, emotional regulation and the knowledge of breast-feeding.
Interventions
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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.
Education
Doctors will give suggestions and the medical orders to all participants, including dietary, emotional regulation and the knowledge of breast-feeding.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
FEMALE
No
Sponsors
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Beijing Hospital of Traditional Chinese Medicine
OTHER
Beijing University of Chinese Medicine
OTHER
Responsible Party
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Xiaohua Pei
Principal Investigator, Clinical Professor, Academic Leader of Breast Disease in Traditional Chinese Medicine.
Principal Investigators
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Xiaohua Pei, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing University of Chinese Medicine
Locations
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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, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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CFH2018-7032
Identifier Type: -
Identifier Source: org_study_id
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