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Preventive and Therapeutic Effects of Traditional Chinese Medicine on Incomplete SLE: A Prospective Cohort Study

Preventive and Therapeutic Effects of Traditional Chinese Medicine on Incomplete SLE: A Prospective Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026001580
Enrollment
Unknown
Registered
2026-06-23
Start date
2026-06-28
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemic lupus erythematosus (SLE)

Interventions

Non-exposure group:Only conventional Western medical treatment or conservative treatment is accepted, and TCM syndrome differentiation treatment is not accepted. If TCM treatment is started during fol
Exposure group:On the basis of conventional Western medical treatment or conservative treatment, patients voluntarily receive TCM syndrome differentiation-based therapy, and the total duration of TCM

Sponsors

The Second Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Females aged 18-60 years; 2. ANA above the laboratory normal reference range; 3. Meet =1 item of the 2012 SLICC SLE classification criteria (excluding ANA above the laboratory normal reference range); (See Attachment 1) 4. Do not meet any SLE classification criteria (including the 1997 ACR SLE classification criteria, the 2012 SLICC classification criteria, or the 2019 EULAR/ACR joint classification criteria); 5. Patients are informed and agree to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Patients with other clearly diagnosed rheumatic immune diseases such as rheumatoid arthritis, systemic sclerosis, idiopathic inflammatory myopathy, Sjögren's syndrome, systemic vasculitis, and antiphospholipid syndrome; 2. Patients with malignant tumors, severe organ diseases, or severe mental disorders; 3. Patients in pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
The proportion of patients who meet the current classification criteria for SLE (SLE conversion rate);

Secondary

MeasureTime frame
Systemic Lupus Erythematosus Risk Probability Index;The number of items meeting the 2012 SLICC classification criteria.;Meets the 2019 EULAR/ACR classification criteria score.;The time to progress to SLE;

Countries

China

Contacts

Public ContactWang Xinchang

The Second Affiliated Hospital of Zhejiang Chinese Medical University

ossani@126.com13065714635

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026