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Recruiting Phase 2 NCT06058546

Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

Trial Parameters

Condition Plaque Psoriasis
Sponsor Tasly Pharmaceutical Group Co., Ltd
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 180
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2023-11-23
Completion 2025-10
Interventions
Jiuweihuaban Pill placebolow dose Jiuweihuaban Pillhigh dose Jiuweihuaban Pill

Brief Summary

This study will evaluate the efficacy and safety of Jiuweihuaban Pill in the treatment of moderate to severe plaque psoriasis(syndrome of blood-heat ).

Eligibility Criteria

Inclusion Criteria: 1. Aged 18-65, male or female. 2. The diagnosis of plaque psoriasis vulgaris was in accordance with the western diagnostic criteria 3. Conformed to the TCM syndrome differentiation standard of plaque psoriasis with Blood-heat syndrome. 4. At screening period: 3 ≤PASI≤ 20, 3%≤BSA≤ 10% and sPGA≥2. 5. Willing to participate voluntarily and sign a written informed consent. Exclusion Criteria: 1. Psoriasis caused by drug-induced factors; combined with non-plaque Psoriasis at screening (such as guttate,arthropathica, pustular, erythrodermic and other types of Psoriasis); The skin lesions are exclusively observed in subjects with specific areas such as the face, scalp, nails, skin folds, glans penis, mucous membranes, palms, and soles. 2. Systemic therapy with non-biological drugs within 4 weeks prior to randomization, including but not limited to systemic corticosteroids, retinoids, methotrexate, and cyclosporine. 3. Systemic therapy with biological drugs within 12 weeks

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