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

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

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

Study Overview

• Status: Recruiting
• Conditions: Plasma Cell Mastitis
• Intervention / Treatment: Drug: Traditional Chinese medicine

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nan Niu, MD; Phone Number: +8618940256668; Email: niunannancy@163.com
• Study Contact Backup: Name: Caigang Liu, MD; Email: liucg@sj-hospital.org

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Shengjing Hospital of China Medical University
      • Contact: Caigang Liu, PHD; Phone Number: +86 18940254967; Email: liucg@sj-hospital.org
      • Principal Investigator: Caigang Liu, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Traditional herbal medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure rate	the proportion of patients who completely respond to the treatment at any study time point	During treatment（1 month to 6 months）
Clinical response rate	the proportion of patients who respond to the treatment at any study time point	During treatment（1 month to 6 months）

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical rate	the proportion of patients who receive surgery at any study time point	During treatment（1 month to 6 months）
Local recurrence rate	the proportion of patients who recur at any study time point	Within 6 months after treatment
Adverse events (AE) and serious adverse events (SAE)	For adverse events (AE) and serious adverse events (SAE), refer to NCI-CTC AE 5.0 standard.	During treatment（1 month to 6 months）

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression of immune cells	Expression of immune cells (T cell, B cell, NK cell)	During treatment（1 month to 6 months）
Expression of cytokines (IL, INF-r, TNF-a)	Expression of cytokines (IL, INF-r, TNF-a)	During treatment（1 month to 6 months）
C-reactive protein	Expression of c-reactive protein	During treatment（1 month to 6 months）
Clinical symptom scores	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.	During treatment（1 month to 6 months）

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Principal Investigator: Caigang Liu, Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: September 3, 2022
• First Submitted That Met QC Criteria: September 3, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 3, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Pregnancy Complications; Puerperal Disorders; Mastitis
• Other Study ID Numbers: Shengjing-LCG013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No