Optimally Sequential Treatment of Integrated Chinese and Western Medicine for Psoriasis: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 378
- 试验地点
- 6
- 主要终点
- Psoriasis area and severity index
研究概览
简要总结
The purpose of this study was to explore intervention time of Chinese medicine and specification of a sequential treatment plan for severe psoriasis with Chinese and Western medicine.
详细描述
Psoriasis is a chronic, relapsing, inflammatory disease that seriously affects the quality of life of patients. Both Chinese medicine and Western medicine have many methods for treating psoriasis, each with its own advantages and disadvantages, but the pursuit of green and effective treatment programs is still the focus of the work of specialists and researchers. How to combine the existing safe and effective Chinese and Western medicine methods organically, and to achieve the purpose of improving efficacy under the premise of ensuring safety, is the motivation for carrying out this research.
The treatments involved in this study include cupping, phototherapy, and Chinese medicine. All three methods have sufficient literature to confirm their effectiveness in treating plaque psoriasis. The research team hopes to obtain a best combination of three treatments for plaque psoriasis by using a multicenter, randomized, single-blind, 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
- Single (Participant)
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
- •Plaque psoriasis, the course of disease is not limited.
- •Skin lesions involving ≤ 15% BSA (the lesions are mainly located in the trunk and / or limbs, palm / sole, face / scalp, vulva area is not included).
- •18 to 65 years old, male or female patient.
- •Informed consent must be obtained.
排除标准
- •other active skin diseases which may affect the condition assessment are present.
- •Patients who received systematic treatment of research drugs, biological agents and immunosuppressive agents within 2 months.
- •Patients who received treatment with topical glucocorticoids, phototherapy, etc. within 2 weeks.
- •Those with severe, uncontrollable local or systemic acute or chronic infections.
- •patients with severe systemic diseases; or clinical test indicators in one of the following cases: alanine transferase or glutamate transferase increased by >1.5 times the upper limit of normal; serum creatinine increased by >1.5 times the upper limit of normal Any of the main blood routine indicators (white blood cell count, red blood cell count, hemoglobin amount, platelet count) below the lower limit of normal; or other laboratory abnormalities judged by the investigator are not suitable for participation in this trial.
- •Patients with a history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity.
- •Patients underwent major surgery within 8 weeks or will require such surgery during the study period.
- •Patients who are pregnant or in lactation.
- •Those have a history of alcohol abuse, drug abuse or drug abuse.
- •Patients with a history of serious mental illness or family history.
- •Patients with a family history of cancer.
- •Other reasons that the investigator considered inappropriate to participate in the study.
研究组 & 干预措施
Chinese medicine internal treatment group
Participants in Chinese medicine internal treatment group will receive Jueyin granule two times daily after meals and moving cupping placebo therapy three times per week for 8 weeks.
干预措施: Jueyin granules (Drug)
Chinese medicine internal treatment group
Participants in Chinese medicine internal treatment group will receive Jueyin granule two times daily after meals and moving cupping placebo therapy three times per week for 8 weeks.
干预措施: moving cupping placebo therapy (Device)
Chinese medicine external treatment group
Participants in Chinese medicine internal treatment group will receive Jueyin placebo granule two times daily after meals and moving cupping therapy three times per week for 8 weeks.
干预措施: moving cupping therapy (Device)
Chinese medicine external treatment group
Participants in Chinese medicine internal treatment group will receive Jueyin placebo granule two times daily after meals and moving cupping therapy three times per week for 8 weeks.
干预措施: Jueyin placebo granules (Drug)
Chinese medicine treatment group
Participants in Chinese medicine treatment group will receive Jueyin granule two times daily after meals, moving cupping therapy and NB-UVB placebo therapy three times per week for 8 weeks.
干预措施: Jueyin granules (Drug)
Chinese medicine treatment group
Participants in Chinese medicine treatment group will receive Jueyin granule two times daily after meals, moving cupping therapy and NB-UVB placebo therapy three times per week for 8 weeks.
干预措施: moving cupping therapy (Device)
Chinese medicine treatment group
Participants in Chinese medicine treatment group will receive Jueyin granule two times daily after meals, moving cupping therapy and NB-UVB placebo therapy three times per week for 8 weeks.
干预措施: NB-UVB placebo phototherapy (Device)
Western medicine treatment group
Participants in Western medicine treatment group will receive Jueyin placebo granules two times daily after meals, moving cupping placebo therapy and NB-UVB therapy three times per week for 8 weeks.
干预措施: NB-UVB therapy (Device)
Western medicine treatment group
Participants in Western medicine treatment group will receive Jueyin placebo granules two times daily after meals, moving cupping placebo therapy and NB-UVB therapy three times per week for 8 weeks.
干预措施: Jueyin placebo granules (Drug)
Western medicine treatment group
Participants in Western medicine treatment group will receive Jueyin placebo granules two times daily after meals, moving cupping placebo therapy and NB-UVB therapy three times per week for 8 weeks.
干预措施: moving cupping placebo therapy (Device)
Integrated Chinese and Western Medicine Treatment Group
Participants in Chinese and Western Medicine Treatment Group will receive Jueyin granules two times daily after meals, moving cupping therapy and NB-UVB therapy three times per week for 8 weeks.
干预措施: Jueyin granules (Drug)
Integrated Chinese and Western Medicine Treatment Group
Participants in Chinese and Western Medicine Treatment Group will receive Jueyin granules two times daily after meals, moving cupping therapy and NB-UVB therapy three times per week for 8 weeks.
干预措施: moving cupping therapy (Device)
Integrated Chinese and Western Medicine Treatment Group
Participants in Chinese and Western Medicine Treatment Group will receive Jueyin granules two times daily after meals, moving cupping therapy and NB-UVB therapy three times per week for 8 weeks.
干预措施: NB-UVB therapy (Device)
结局指标
主要结局
Psoriasis area and severity index
时间窗: Up to 56 days after treatment.
Psoriasis Area and Severity Index 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
- Dermatology Life quality index(DLQI)(Up to 56 days after treatment.)
- Physician Global Assessment (PGA)(Up to 56 days after treatment.)
- Visual Analogue Score (VAS)(Up to 56 days after treatment.)
- TCM symptom score(Up to 56 days after treatment.)
- Body surface area (BSA)(Up to 56 days after treatment.)
- Patient-reported quality of life (PRQoL)(Up to 56 days after treatment.)