Objectives of Study:
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The aim of this randomized, double-blind, placebo-parallel controlled trial is to determine whether oral Chinese herbal medicine (Guben Qushi Huayu formula) in combination with Ixekizumab is effective and safe in the treatment of severe psoriasis. Additionally, the study is to provide preliminary data for the next phase of multicenter randomized controlled trial.
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Exclusion criteria:
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1.Pregnant or lactating women, or those who plan pregnancy during the study period.
2.Patients with Self-Rating Anxiety Scale (SAS) score > 50 or Self-rating depression scale (SDS) standard score > 53, or with other mental disorders.
3.Patients with severe primary diseases such as respiratory system and circulatory system that cannot be controlled by conventional medication; patients with severe infection, tuberculosis, hepatitis and other infectious history, lymphocyte proliferation, hematopoietic system abnormalities, tumor; patients with severe water, electrolyte and acid-base balance disorder; patients with primary or secondary immune deficiency and hypersensitivity. Or clinical test indicators are one of the following cases: alanine aminotransferase or glutamic oxaloacetic transaminase increase > 3 times of the upper limit of normal value; creatinine is higher than 1.5 times of the upper limit of normal value; creatinine > 1.5 times of the upper limit of normal value; serological test of human immunodeficiency virus (HIV) is positive; Any main indicators of blood test is below the lower limit of normal; or patients are assessed as unsuitable for this trial by researchers through other abnormal laboratory tests.
4.Patients who are known to be allergic to the medication and its related ingredients used in this study and those with related medication ingredients.
5.Those who are participating in other medication clinical trials or have participated in other clinical trials within 4 weeks.
6.Those who used traditional Chinese medicine or Chinese herbal products or topical therapy (antibiotics, external corticosteroids, vitamin D3 analogues, calcineurin inhibitors, keratolytics, et al) within 2 weeks; those who had used oral systemic therapies (methotrexate, ciclosporin A, acitretin, fumarates, et al) or ultraviolet treatment within 4 weeks; those who had received biological agents within 5 half-life periods (17.5 days of Etanercept, 50 days of Infliximab, 70 days of Adalimumab, 105 days of Ustekinumab, 135 days of Secukinumab, et al).
7.Patients are assessed as unsuitable for inclusion by the researchers.
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