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A Prospective Study of Madecassoside Tablets in Sclerotic Chronic Graft-versus-Host Disease After Allo-HSCT

RecruitingPhase 2Ages 14 Years - 65 YearsAllWeiShi
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In plain words

What the trial is, and whether it could suit you

Sclerotic chronic graft-versus-host disease (scl-cGVHD) is a severe subtype of chronic GVHD after allogeneic hematopoietic stem cell transplantation (allo-HSCT), characterized by skin sclerosis, fascial involvement, and restricted joint mobility, leading to substantial functional impairment and reduced quality of life. Current standard therapies, including corticosteroids and other immunosuppressive agents, have limited efficacy in patients with refractory or steroid-dependent disease. Madecassoside tablets, a standardized extract of Centella asiatica, have demonstrated anti-inflammatory and anti-fibrotic properties in previous studies and may provide therapeutic benefit in fibrotic diseases. This study is a prospective, multicenter, single-arm phase 2 clinical trial designed to evaluate the efficacy and safety of madecassoside tablets combined with standard therapy in patients with sc

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Ability to understand and willingness to sign written informed consent; 2. Age 14 to 65 years; 3. Diagnosis of sclerotic chronic graft-versus-host disease (scl-cGVHD) according to the 2014 NIH consensus criteria, including superficial or deep skin sclerosis, fasciitis, or restricted joint mobility; 4. Prior treatment history meeting at least one of the following: * Received systemic corticosteroid therapy for โ‰ฅ12 months and at least 1 additional systemic therapy; OR * Received corticosteroid therapy and at least 2 additional systemic therapies; 5. Karnofsky Performance Status (KPS) score โ‰ฅ60; 6. Absolute neutrophil count \>1,000/ฮผL; 7. Platelet count โ‰ฅ50,000/ฮผL. Exclusion Criteria: * 1\. Total bilirubin \>1.5 times the upper limit of normal; 2. Creatinine clearance \<30 mL/min; 3. Uncontrolled infection; 4. Uncontrolled cardiovascular or pulmonary disease; 5. Any clinical condition that, in the investigator's judgment, makes the participant unsuitable for study participation.
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What it tests

  • Madecassoside Tablets
  • Standard Therapy
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Where

1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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