Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome: a Randomised, Double-blind, Doubledummy, Multicentre Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 216
- 试验地点
- 5
- 主要终点
- Psoriasis area and severity index (PASI)
研究概览
简要总结
We designed this study as a multicenter, randomized, double blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of psoriasis with blood stasis syndrome.
详细描述
Psoriasis is a chronic, relapsing, inflammatory, multisystem disease characterized by infiltration of inflammatory cells, hyperplasia of epidermal keratinocytes, and abnormal differentiation. Latest data estimate that the prevalence of psoriasis in adults has increased to 11.43%, which shows that the control and treatment of psoriasis is still insufficient. Recent studies showed that traditional Chinese medicine (TCM) is one of the effective methods for the treatment of psoriasis. More and more evidences support the recognition of psoriasis not only affects the skin, but also suffers a chronic multisystem inflammation. In addition, blood-stasis accumulates in meridians, viscera and limbs to form a variety of syndromes with psoriasis for so long, which similar to many metabolic related diseases. Therefore, the method of promoting blood circulation and removing blood stasis has always been the focus of TCM treatment and prevention of psoriasis. This multicenter, randomized, double-blind, placebo-controlled trial will provide high-quality clinical evidences for evaluating the efficacy, safety and recurrence rate of Taodan granule, a representative prescription for the treatment of psoriasis with blood stasis syndrome, in the treatment of psoriasis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes;
- •Skin lesions involve ≤10% BSA (the lesions are mainly located in the trunk and/or limbs, palm/sole, face/scalp, vulva area is not included);
- •Age between 18 and 65 years old;
- •Those who voluntarily participate in the study and sign informed consent.
排除标准
- •Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
- •Other active skin diseases may affect the condition assessment;
- •Received research drugs, biological agents and immunosuppressive agents within 1 month;
- •2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
- •During severe, uncontrollable local or systemic acute or chronic infections;
- •Patients with severe systemic diseases; or clinical test indicators in one of the following conditions: alanine aminotransferase or aspartate aminotransferase increased by >1.5 times the upper limit of normal; creatinine increased by 1.5 times the upper limit of normal; blood routine indicators (white blood cell count) Any one of the red blood cell count, hemoglobin amount, and platelet count) is below the lower limit of normal; or other laboratory abnormalities are judged by the investigator to be unsuitable for participation in the trial;
- •A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
- •Such surgery will be required during major surgery or study during 8 weeks;
- •Pregnant or lactating women;
- •A person with a history of alcohol abuse, drug abuse or drug abuse;
- •Have a history of serious mental illness or family history;
- •Other reasons researchers believe that it is inappropriate to participate in this research.
研究组 & 干预措施
Oral Chinese medicine
Participants in experimental group will receive Taodan granule two times daily after meals three times per week for 8 weeks.
干预措施: Taodan Granules (Drug)
Oral Chinese medicine placebo
Participants in placebo group will receive Taodan granule two times daily after meals three times per week for 8 weeks.
干预措施: Taodan Granules Placebo (Drug)
结局指标
主要结局
Psoriasis area and severity index (PASI)
时间窗: Up to 56 days after treatment
Psoriasis Area and Severity Index (PASI) involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - \<10%, 2 - 10-\<30%, 3 - 30-\<50%, 4 - 50-\<70%, 5 - 70-\<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.
次要结局
- Body surface area (BSA)(Up to 56 days after treatment)
- Physician Global Assessment (PGA)(Up to 56 days after treatment)
- TCM symptom score(Up to 56 days after treatment)
- Patient-reported quality of life (PRQoL)(Up to 56 days after treatment)
- Visual Analogue Score (VAS)(Up to 56 days after treatment)
- Dermatology Life quality index(DLQI)(Up to 56 days after treatment)