A Multi-center, Randomized, Double-blind Controlled Study on the Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Psoriasis area and severity index (PASI)
研究概览
简要总结
The purpose of this study is to objectively and standardly evaluate the clinical efficacy and safety of sequential treatment of psoriasis with traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial.
详细描述
Psoriasis is a chronic, recurrent, inflammatory disease. The incidence of this disease is increasing year by year, seriously affecting people's quality of life. Biologic agents have the advantages of rapid and efficient treatment of moderate and severe psoriasis, but their safety and recurrence are still seriously affect the application. Traditional Chinese medicine treatment of psoriasis has the advantages of fewer adverse reactions, low recurrence rate and improvement of patients' systemic symptoms while exerting the curative effect. The prevention and treatment of psoriasis by combining traditional Chinese and Western medicine has become the academic consensus. The sequential treatment of psoriasis with biological agents combined with Traditional Chinese medicine has a better therapeutic effect than that of single therapy. At present, the sequential treatment of psoriasis with targeted biological agents combined with traditional Chinese medicine has not been reported in the literature, and there is a lack of high-level clinical evidence to support it. Therefore, this project aims to provide evidence support for the clinical efficacy and safety of sequential treatment of psoriasis by traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •It conforms to the western diagnostic criteria of plaque psoriasis and the diagnostic criteria of TCM syndrome of blood heat syndrome;
- •Physician global assessment (PGA) ≥3, psoriasis area and severity index (PASI) score ≥12, and body surface area (BSA) ≥ 10% at screening and baseline;
- •Aged between 18 and 70;
- •Those who voluntarily participate in the study and sign the informed consent.
排除标准
- •Erythrodermic psoriasis patients, arthropathic psoriasis patients, pustular psoriasis patients;
- •There are other active skin diseases that may affect the evaluator;
- •Have systematically received other investigational drugs within 1 month;
- •Received external glucocorticoid and phototherapy within 2 weeks;
- •During a period of severe and uncontrollable local or systemic acute or chronic infection;
- •Infected persons with tuberculosis;
- •Patients with viral hepatitis;
- •Serious systemic disease; Or clinical test indicators belong to one of the following cases of patients: alanine aminotransferase or glutamic-oxalacetic transaminase increase > 1.5 times the upper limit of normal value; Creatinine increase > 1.5 times the upper limit of normal value; Any one of the major blood routine indicators (white blood cell count, red blood cell count, hemoglobin amount, platelet count) is lower than the lower limit of normal value; Or other abnormal laboratory tests determined by the investigator to be unsuitable for the study;
- •Patients with a history of malignant tumor and patients with primary or secondary immune deficiency and hypersensitivity;
- •Participants in clinical trials of other drugs within 3 months;
- •Those who have undergone major surgery within 8 weeks or will require such surgery during the study period;
- •For fertile women of childbearing age who did not use highly effective contraception from the screening period until the end of the last dose;
- •Pregnant or lactating women;
- •Persons with a history of alcohol, drug or substance abuse;
- •Persons with a serious history of mental illness or family history;
- •For other reasons, the researcher considers it inappropriate to participate in this study.
研究组 & 干预措施
Ixekizumab (4 weeks) + Jueyin Granules (12 weeks)
Subjects received Ixekizumab in the first 4 weeks (biologic treatment period); After the cessation of biologic treatment, only Jueyin Granules was used in the 12-week traditional Chinese medicine treatment period.
干预措施: Ixekizumab+Jueyin Granules (Drug)
Ixekizumab (4 weeks) + Jueyin placebo Granules(12 weeks)
Subjects received Ixekizumab in the first 4 weeks (biologic treatment period); After the cessation of biologic treatment, only Jueyin placebo Granules was used in the 12-week traditional Chinese medicine treatment period.
干预措施: Ixekizumab+Jueyin placebo Granules (Drug)
结局指标
主要结局
Psoriasis area and severity index (PASI)
时间窗: Up to 168 days after treatment
Psoriasis area and severity index (PASI) score and recurrence assessment. Psoriasis area and severity index (PASI) scores were assessed for all patients at each follow-up. Recurrence was defined as a 50% reduction in maximum PASI improvement from baseline at week 40.
次要结局
- Body surface area (BSA)(Up to 168 days after treatment)
- Physician Global Assessment (PGA)(Up to 168 days after treatment)
- Visual Analogue Score (VAS)(Up to 168 days after treatment)
- Patient-reported quality of life (PRQoL)(Up to 168 days after treatment)
- Dermatology Life quality index(DLQI)(Up to 168 days after treatment)
- CM symptom score(Up to 168 days after treatment)