A Phase 2 interventional study of Traditional Chinese medicine in Plasma Cell Mastitis, sponsored by Shengjing Hospital. Status unknown at 1 site in China. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by Shengjing Hospital · Phase 2, Interventional, and Treatment
This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for 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. 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.
31 studies on the registry are indexed under Mastitis; 7 are open to participants now.
This study's planned enrollment of 50 is below the median of 114 across 16 interventional studies indexed under Mastitis.
Browse Mastitis studies →Shengjing Hospital is the lead sponsor of 127 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Traditional Chinese medicine, twice daily
Drug: Traditional Chinese medicine
Traditional Chinese medicine, oral administration, twice daily
Also known as: Traditional herbal medicine
Clinical cure rate
the proportion of patients who completely respond to the treatment at any study time point
Time frame: During treatment（1 month to 6 months）
Clinical response rate
the proportion of patients who respond to the treatment at any study time point
Time frame: During treatment（1 month to 6 months）
Surgical rate
the proportion of patients who receive surgery at any study time point
Time frame: During treatment（1 month to 6 months）
Local recurrence rate
the proportion of patients who recur at any study time point
Time frame: 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.
Time frame: During treatment（1 month to 6 months）
Expression of immune cells
Expression of immune cells (T cell, B cell, NK cell)
Time frame: During treatment（1 month to 6 months）
Expression of cytokines (IL, INF-r, TNF-a)
Expression of cytokines (IL, INF-r, TNF-a)
Time frame: During treatment（1 month to 6 months）
C-reactive protein
Expression of c-reactive protein
Time frame: 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.
Time frame: During treatment（1 month to 6 months）
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Drugs, Chinese Herbal