Plasma Cell MastitisPhase 2NCT05530226
A Single Arm Study of Traditional Chinese Medicine for Plasma Cell Mastitis
A Phase 2 study testing Traditional Chinese medicine in people with Plasma Cell Mastitis, run by Shengjing Hospital at 1 site in China.
Trial summary
This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for plasma cell mastitis. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Plasma Cell Mastitis
- What is being tested?
- Traditional Chinese medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Caigang Liu, MD contact
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Caigang Liu, PHD, +86 18940254967, liucg@sj-hospital.org
Caigang Liu, PHD
About this study
Official title: 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.
Read the 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.
- Conditions
- Plasma Cell Mastitis
- Being tested
- Traditional Chinese medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese medicineDrug
Also called Traditional herbal medicine
Traditional Chinese medicine, oral administration, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese medicine group | Experimental | Traditional Chinese medicine, twice daily Receives: Drug: Traditional Chinese medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
the proportion of patients who completely respond to the treatment at any study time point
Measured: During treatment（1 month to 6 months）
Clinical response rate
the proportion of patients who respond to the treatment at any study time point
Measured: During treatment（1 month to 6 months）
Secondary outcomes (3)
Surgical rate
the proportion of patients who receive surgery at any study time point
Measured: During treatment（1 month to 6 months）
Local recurrence rate
the proportion of patients who recur at any study time point
Measured: 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.
Measured: During treatment（1 month to 6 months）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Oct 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasma Cell MastitisStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caigang Liu, Shengjing Hospital
- Investigators
- Caigang Liu, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530226
- Sponsor's protocol ID
- Shengjing-LCG013
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36917037
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Study of Traditional Chinese Medicine for Treatment of Plasma Cell Mastitis
- ClinicalTrials.gov ID
- NCT05530226
- Acronym / sponsor ID
- Shengjing-LCG013
- Conditions
- Plasma Cell Mastitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for plasma cell mastitis.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm study
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese medicine group | Experimental | Drug: Traditional Chinese medicineTraditional Chinese medicine, twice daily |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese medicineAlso: Traditional herbal medicineTraditional Chinese medicine, oral administration, twice daily | Drug | Traditional Chinese medicine group |
Primary outcome
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
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
3 secondary outcomes
Surgical rate
Time frame: During treatment（1 month to 6 months）
Local recurrence rate
Time frame: Within 6 months after treatment
Adverse events (AE) and serious adverse events (SAE)
Time frame: During treatment（1 month to 6 months）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Derived from this study: PubMed 36917037Liu 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.
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Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastiti
Plasmacytic Mastitis, Granulomatous Lobular Mastitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caigang Liu, MD contact
Caigang Liu principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Traditional Chinese medicine in people with Plasma Cell Mastitis, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan Niu, MD (+8618940256668, niunannancy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate (time frame: During treatment（1 month to 6 months）). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05530226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.