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Study on Qingying Huashi Granules for Treating Dermatomyositis in a Multicenter Randomized Controlled Trial

Study on Qingying Huashi Granules for Treating Dermatomyositis in a Multicenter Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002437
Enrollment
Unknown
Registered
2025-12-10
Start date
2025-10-16
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Dermatomyositis

Interventions

Qingying Huashi Group:Prednisone: Initial dose of 0.5-1.0 mg/kg/day, determined based on the severity of the condition by the investigator. Starting from week 4, the dose is gradually tapered accordin
Control Group:Prednisone: Initial dose of 0.5-1.0 mg/kg/day, determined based on the severity of the condition by the investigator. Starting from week 4, the dose is gradually tapered according to dis

Sponsors

Department of Rheumatology and Immunology The Second Affiliated Hospital of Zhejiang University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Conform to the 2017 EULAR/ACR classification criteria for dermatomyositis in adult and juvenile IIM; (2) Patients with heat-toxicity, blood-stasis, and dampness obstruction type DM; (3) Individuals aged between 18 and 65 years old.

Exclusion criteria

Exclusion criteria: (1) Patients with severe infections or malignant tumors; NYHA class III-IV heart failure patients; individuals with abnormal liver function not caused by DM (e.g., ALT/AST levels exceeding twice the upper limit of normal); patients with end-stage organ dysfunction; individuals with positive serological tests for HIV or other pathogenic organisms. (2) Pregnant or breastfeeding women; individuals with uncontrolled psychiatric conditions. (3) Patients with other rheumatologic conditions, such as rheumatoid arthritis, systemic lupus erythematosus, or Sjögren's syndrome.

Design outcomes

Primary

MeasureTime frame
Total Illness Score (TIS);

Secondary

MeasureTime frame
Muscle enzyme spectrum;TCM Syndrome Score;Hormone Usage;Myositis Spectrum;Inflammatory markers (erythrocyte sedimentation rate, C-reactive protein);Health Assessment Questionnaire (HAQ);Complications occurrence;

Countries

China

Contacts

Public ContactWeijie Wang

The Second Affiliated Hospital of Zhejiang University of Chinese Medicine

jack1987168@163.com18072946549

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026