A Phase 2/3 interventional study of CHPM (Chinese Herbal Patent Medicine ) and Antibiotics Cefdinir Capsules in Mastitis Acute Female, sponsored by Beijing University of Chinese Medicine. Status unknown at 3 sites in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Beijing University of Chinese Medicine · Phase 2/3, Interventional, and Treatment
Among 17 studies in Breast Feeding with a site in China — 2 open to participants now, 2 under way, none of them phase 3. Breast Feeding · China.
Among the 17 studies in Breast Feeding with a site in China, this one is the 5th largest by planned enrollment of the 12 interventional ones that give a count, is one of 3 that started in 2018, is the only one in phase 2/3, and was the 6th registered.
1,082 studies on the registry are indexed under Breast Feeding; 218 are open to participants now.
Browse Breast Feeding studies →2 of the 17 studies in Breast Feeding with a site in China are open now. Recruiting first, the newest first:
The Hong Kong Polytechnic University · Sites in China
Ages 1 mo–40 yrs
The Third Xiangya Hospital of Central South University · Sites in China
Ages 18–50 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 128 Breast Feeding studies recruiting now, 67 (52%) set no upper age limit and 59 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.
This study: 18 Years to 70 Years · female · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 306 is above the median of 100 across 845 interventional studies indexed under Breast Feeding.
Median enrollment 206 across the 12 interventional studies, 200 across the 5 observational. Of the 12 that completed or were terminated, 1 (8%) have results posted.
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3 of 17 have an industry lead sponsor. The 10 most frequent:
Beijing University of Chinese Medicine is the lead sponsor of 32 studies on the registry; 8 are open to participants now.
Beijing University of Chinese Medicine has 1 study filed under Breast Feeding — fewer than ten, so there is no comparison to draw.
1 of the studies in Breast Feeding with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07913438The Third Xiangya Hospital of Central South UniversityDevelopment and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model | 2027-03-11 |
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Among the 17 studies in Breast Feeding with a site in China, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 (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, 0.1g/tid for 3 days, follow-up for 7 days. Education, basic medical order.
Drug: Antibiotics Cefdinir Capsules · Behavioral: Education
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
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"
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
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.
Also known as: Cefdinir Capsules of "short course group"
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.
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.
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.
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.
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.
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 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.
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
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.
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
Measured by the routine blood test. To evaluate the changing from the baseline to the end of 3-day treatment.
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
Measured by the routine blood test. To evaluate the changing from the baseline to the end of 3-day treatment.
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.
Measured by the routine blood test. To evaluate the changing from the baseline to the end of 3-day treatment.
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
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.
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.
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).
Time frame: 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
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.
Time frame: Clinical evaluation will be conducted after 3-day treatment.
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.
Time frame: Clinical evaluation will be conducted after 3-day treatment.
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2018 (actual). Primary completion is estimated for Dec 2020, 24 months after the start.
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This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Beijing University of Chinese Medicine