ITMCTR2100005464尚未招募1 期
Chinese herbal medicine (Guben Qushi Huayu formula) in combination with Ixekizumab for the prevention of relapse with severe psoriasis
Guangdong Provincial Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •1.The age is 18-70 years old, both male and female;
- •2.The patients with PASI=10 or BSA=10 met the diagnostic criteria of severe psoriasis;
- •3.Patients who meet the indications of biological agents Ixekizumab and have no history of inflammatory bowel disease (IBD);
- •4.Patients who sign informed consent.
排除标准
- •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.
研究者
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