NCT05530226

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

September 3, 2022

Last Update Submit

September 3, 2022

Conditions

Plasma Cell Mastitis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Surgical rate

    During treatment（1 month to 6 months）

  • Local recurrence rate

    Within 6 months after treatment

  • Adverse events (AE) and serious adverse events (SAE)

    During treatment（1 month to 6 months）

Other Outcomes (4)

  • Expression of immune cells

    During treatment（1 month to 6 months）

  • Expression of cytokines (IL, INF-r, TNF-a)

    During treatment（1 month to 6 months）

  • C-reactive protein

    During treatment（1 month to 6 months）

  • +1 more other outcomes

Study Arms (1)

Traditional Chinese medicine group

EXPERIMENTAL

Traditional Chinese medicine, twice daily

Drug: Traditional Chinese medicine

Interventions

Traditional Chinese medicineDRUG

Traditional Chinese medicine, oral administration, twice daily

Also known as: Traditional herbal medicine
Traditional Chinese medicine group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.
  • Patients with serious underlying diseases, such as diabetes, cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system diseases.
  • 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.
  • Recent use of antidepressants and other psychotropic drugs.
  • Hormone and immunosuppressive therapy were used one month before enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Related Publications (1)

  • Liu C, Yu H, Chen G, Yang Q, Wang Z, Niu N, Han L, Zhao D, Wang M, Liu Y, Yang Y. An herbal drug combination identified by knowledge graph alleviates the clinical symptoms of plasma cell mastitis patients: A nonrandomized controlled trial. Elife. 2023 Mar 14;12:e84414. doi: 10.7554/eLife.84414.

    PMID: 36917037DERIVED

MeSH Terms

Interventions

Medicine, Chinese Traditional

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeutics

Study Officials

  • Caigang Liu

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Niu, MD

CONTACT

+8618940256668niunannancy@163.com

Caigang Liu, MD

CONTACT

liucg@sj-hospital.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single arm study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2022

First Posted

September 7, 2022

Study Start

October 1, 2021

Primary Completion

October 31, 2022

Study Completion

March 31, 2023

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations

CN(1)