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A Single Arm Study of Traditional Chinese Medicine for Plasma Cell Mastitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05530226
Recruitment Status : Recruiting
First Posted : September 7, 2022
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
Caigang Liu, Shengjing Hospital

Study Description
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Brief Summary:
This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for plasma cell mastitis.

Condition or disease Intervention/treatment Phase
Plasma Cell Mastitis Drug: Traditional Chinese medicine Phase 2

Detailed Description:
This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for plasma cell mastitis. This study will include 50 patients with plasma cell mastitis. After providing written informed consent, the participants will receive traditional herbal medicine twice daily. Efficacy will be assessed every 15 days. If the disease progresses, the participant will withdraw from the trial.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm Study of Traditional Chinese Medicine for Treatment of Plasma Cell Mastitis
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Traditional Chinese medicine group
Traditional Chinese medicine, twice daily
 Drug: Traditional Chinese medicine
Traditional Chinese medicine, oral administration, twice daily
Other Name: Traditional herbal medicine


Outcome Measures
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Primary Outcome Measures :
  1. Clinical cure rate [ Time Frame: During treatment（1 month to 6 months） ]
    the proportion of patients who completely respond to the treatment at any study time point

  2. Clinical response rate [ Time Frame: During treatment（1 month to 6 months） ]
    the proportion of patients who respond to the treatment at any study time point


Secondary Outcome Measures :
  1. Surgical rate [ Time Frame: During treatment（1 month to 6 months） ]
    the proportion of patients who receive surgery at any study time point

  2. Local recurrence rate [ Time Frame: Within 6 months after treatment ]
    the proportion of patients who recur at any study time point

  3. Adverse events (AE) and serious adverse events (SAE) [ Time Frame: During treatment（1 month to 6 months） ]
    For adverse events (AE) and serious adverse events (SAE), refer to NCI-CTC AE 5.0 standard.


Other Outcome Measures:
  1. Expression of immune cells [ Time Frame: During treatment（1 month to 6 months） ]
    Expression of immune cells (T cell, B cell, NK cell)

  2. Expression of cytokines (IL, INF-r, TNF-a) [ Time Frame: During treatment（1 month to 6 months） ]
    Expression of cytokines (IL, INF-r, TNF-a)

  3. C-reactive protein [ Time Frame: During treatment（1 month to 6 months） ]
    Expression of c-reactive protein

  4. Clinical symptom scores [ Time Frame: During treatment（1 month to 6 months） ]
    Clinical symptom scores were measured using traditional Chinese medicine clinical symptom assessment with reference to The Disease Diagnosis Curative Effect of Traditional Chinese Medicine Standard. The clinical symptom scales include mass size, swelling, discharge, retraction, abscess, fistula. The higher the score, the worse the symptom. Clinical symptom scores of patients before and after treatment were observed and compared.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet the diagnostic criteria for plasma cell mastitis.
  2. Women aged > 20 years and ≤ 60 years.
  3. Karnofsky Performance Status (KPS) Scale score ≥ 70.
  4. Volunteers to participate in the study, provision of signed informed consent, good compliance and willingness to cooperate with follow-ups.

Exclusion Criteria:

  1. Pregnant and lactating women; fertile women who provide positive results of baseline pregnancy test; women of childbearing age who are unwilling to take effective contraceptive measures during the whole study period.
  2. Patients with serious underlying diseases, such as diabetes, cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system diseases.
  3. Allergic constitution, such as a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients of the drugs used in this trial.
  4. Recent use of antidepressants and other psychotropic drugs.
  5. Hormone and immunosuppressive therapy were used one month before enrollment.
Contacts and Locations
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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): NCT05530226


Contacts
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Contact: Nan Niu, MD +8618940256668 niunannancy@163.com
Contact: Caigang Liu, MD liucg@sj-hospital.org

Locations
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China, Liaoning
Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
Contact: Caigang Liu, PHD    +86 18940254967    liucg@sj-hospital.org   
Principal Investigator: Caigang Liu, PHD         
Sponsors and Collaborators
Shengjing Hospital
Investigators
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Principal Investigator: Caigang Liu Shengjing Hospital
More Information
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Responsible Party: Caigang Liu, Professor, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT05530226    
Other Study ID Numbers: Shengjing-LCG013
First Posted: September 7, 2022    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mastitis
Puerperal Disorders
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Breast Diseases
Skin Diseases