ITMCTR2000003550招募中1 期
Oral Chinese herbal medicine (Guben Huayu Formula) concurrent with methotrexate for patients with moderate-to-severe psoriasis: a randomized controlled trial
Guangdong Provincial Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 性别
- All
入选标准
- •1. The age is 18-70 years old, both male and female;
- •2. The patients who meet the diagnostic criteria of psoriasis and the syndrome differentiation criteria of blood stasis syndrome of traditional Chinese medicine at the same time;
- •3. Patients with moderate to severe illness (BSA >= 3 or PASI >= 3);
- •4. Patients with informed consent.
排除标准
- •1. Pregnant or lactating women, or those who plan pregnancy during the study period;
- •2. Patients with SAS score > 50 or 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 > 1.5 times the upper limit of normal value; creatinine is higher than 1.5 times of the upper limit of normal value; liver fibrosis (p3np) > 2 times of the upper limit of normal value; HIV serological test is positive; any of the main blood routine indicators is lower than the lower limit of normal value; or other abnormal laboratory tests are judged by researchers Patients who are not suitable for this trial;
- •4. Patients who are known to be allergic to the drugs used in this study and those with related drug ingredients;
- •5. Patients with head and face lesions;
- •6. Those who are participating in other drug clinical trials or have participated in other clinical trials within 12 weeks;
- •7. 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);
- •8. The cumulative dose of MTX used in the past was more than 1.5g;
- •9. Patients considered unsuitable for inclusion by the researchers.
研究者
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