Mastitis Acute FemalePhase 2/3NCT03756324

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

A Phase 2/3 study testing CHPM (Chinese Herbal Patent Medicine ), Antibiotics Cefdinir Capsules and Education in people with Mastitis Acute Female, run by Beijing University of Chinese Medicine at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Mastitis Acute Female
What is being tested?: CHPM (Chinese Herbal Patent Medicine ), Antibiotics Cefdinir Capsules and Education
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 306 participants
Where: 3 sitesChina
Study dates: 20 Dec 2018to 31 Mar 2021
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

Xiaohua Pei, MD contact

0086-10-52075224

pxh_127@163.com

Xinyan Jin contact

0086-10-52075224 ext. 8613001144056

20170941260@bucm.edu.cn

China3 sites, 3 recruiting

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

Other trials in China

About this study

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.

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.

Read the 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.

Conditions: Mastitis Acute Female
Being tested: CHPM (Chinese Herbal Patent Medicine ), Antibiotics Cefdinir Capsules, Education
Keywords: Pugongying, Herba Taraxaci, Acute Mastitis, Cefdinir, Randomized controlled trial, Postpartum, Breastfeeding, Lactation, multicenter, Chinese herb, Traditional Chinese medicine, Cephalosporin, Antibiotics
Medical subject headings: Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CHPM (Chinese Herbal Patent Medicine )Drug
Also called Pugongying (Herba Taraxaci) Granules
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 CapsulesDrug
Also called Cefdinir Capsules of "normal course group"
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.
EducationBehavioural
Also called Basic medical order, Medical order
Doctors will give suggestions and the medical orders to all participants, including dietary, emotional regulation and the knowledge of breast-feeding.
Antibiotics Cefdinir CapsulesDrug
Also called Cefdinir Capsules of "short course group"
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.

Study groups in NCT03756324
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Antibiotics Cefdinir Capsules; Behavioral: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

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: 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: 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.
Measured: 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 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.
Measured: 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: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 201831 Mar 2021

First posted28 Nov 2018
Study start20 Dec 2018
Primary completion31 Dec 2020 (estimated)
Study completion31 Mar 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mastitis Acute FemaleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Outcomes assessor
Enrolment: 306 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03756324
Sponsor's protocol ID: CFH2018-7032
Status last verified: Jul 2020
First submitted: 18 Nov 2018
Last updated: 7 Jul 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38029215

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03756324
Acronym / sponsor ID: CFH2018-7032
Conditions: Mastitis Acute Female
Keywords: Pugongying, Herba Taraxaci, Acute Mastitis, Cefdinir, Randomized controlled trial, Postpartum, Breastfeeding, Lactation
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 306 participants (estimated)
Lead sponsor: Beijing University of Chinese MedicineUniversity, hospital or other
Collaborators: Beijing Hospital of Traditional Chinese Medicine
Study start: 20 Dec 2018 (actual)
Primary completion: 31 Dec 2020 (estimated)
Study completion: 31 Mar 2021 (estimated)
First posted: 28 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
CHPM (Chinese Herbal Patent Medicine )	Experimental	Drug: CHPM (Chinese Herbal Patent Medicine ), Behavioral: EducationCHPM (Chinese Herbal Patent Medicine ): Pugongying (Herba Taraxaci) Granules, 15g/tid for 3 days, follow-up for 7 days. Education, basic medical order.
CHPM & Antibiotics Cefdinir Capsules	Experimental	Drug: CHPM (Chinese Herbal Patent Medicine ), Behavioral: Education, Drug: Antibiotics Cefdinir CapsulesCHPM (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.
Antibiotics Cefdinir Capsules	Active comparator	Drug: Antibiotics Cefdinir Capsules, Behavioral: EducationAntibiotics: Cefdinir Capsules, 0.1g/tid for 3 days, follow-up for 7 days. Education, basic medical order.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CHPM (Chinese Herbal Patent Medicine )Also: Pugongying (Herba Taraxaci) GranulesPugongying (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.	Drug	CHPM & Antibiotics Cefdinir Capsules, CHPM (Chinese Herbal Patent Medicine )
Antibiotics Cefdinir CapsulesAlso: Cefdinir Capsules of "normal course group"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.	Drug	Antibiotics Cefdinir Capsules
EducationAlso: Basic medical order, Medical orderDoctors will give suggestions and the medical orders to all participants, including dietary, emotional regulation and the knowledge of breast-feeding.	Behavioural	Antibiotics Cefdinir Capsules, CHPM & Antibiotics Cefdinir Capsules, CHPM (Chinese Herbal Patent Medicine )
Antibiotics Cefdinir CapsulesAlso: Cefdinir Capsules of "short course group"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.	Drug	CHPM & Antibiotics Cefdinir Capsules

Primary outcome

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.
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.
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.

6 secondary outcomes

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 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.
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.
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.
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.
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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
Derived from this study: PubMed 38029215Jin 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiaohua Pei, MD contact

0086-10-52075224

pxh_127@163.com

Xinyan Jin contact

0086-10-52075224 ext. 8613001144056

20170941260@bucm.edu.cn

Xiaohua Pei, MD principal investigator

Beijing University of Chinese Medicine

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaohua Pei, MD (0086-10-52075224, pxh_127@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03756324, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.