Clinical Evaluation of Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 122
- 试验地点
- 5
- 主要终点
- Psoriasis area and severity index (PASI)
研究概览
简要总结
The purpose of this study was to provide evidence support for the effectiveness and safety of moving cupping therapy for plaque psoriasis through clinical studies.
详细描述
Psoriasis is a common chronic and recurrent inflammatory skin disease. The incidence of the disease is increasing year by year, seriously affecting people's quality of life. The systematic treatment of psoriasis in modern medicine is limited of wide application due to the adverse reactions of different degrees and the high economic cost.
Complementary and alternative medicine (CAM) therapies have become an increasingly visible part of dermatology. Cupping is becoming an important therapy in complementary and alternative medicine. Although, moving cupping therapy has been widely used in the treatment of plaque psoriasis and has been recognized by a large number of peers and patients, but still lacks high-quality evidence-based medical evidence. Therefore, the project team intends to provide evidence support for the effectiveness and safety of moving cupping therapy for plaque psoriasis through clinical studies.
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
- •Diagnostic criteria for plaque psoriasis;
- •Skin lesions involve ≤10% BSA (the lesions are mainly located in the torso / limbs, palm / sole, face / scalp, vulva area is not included);
- •Aged between 18 and 65 years.
- •Consent to participate in the research study and sign the informed consent form
排除标准
- •Patients with pustular psoriasis, arthropathic, erythroderma psoriasis and / or drip psoriasis;
- •Plaque psoriasis patients with BSA>10%;
- •Any clinically active skin diseases other than moderate to severe psoriasis vulgaris which might counter or influence the study aim;
- •Patients who used any of the following systemic treatments within 4 weeks before the Baseline visit e.g.: drugs for other studies, immuno-suppressive drugs, biologics;
- •Patients who used topical treatment within 2 weeks before the Baseline visit e.g. corticosteroids ultraviolet-light therapy including sunbathing;
- •Active infectious disease which was hard to control;
- •History of severe systemic disease. Or the clinical test index is one of the following: the ALT or the AST is higher than 1.5 times; Any of the main routine blood indexes (WBC, RBC, HB, PLT) is lower than the limit of normal; or other laboratory abnormalities and patients were judged not to be suitable for this study;
- •Family history of cancer-prone patients;
- •Patients with immunocompromised and can cause skin allergies and infection when moving cupping;
- •Pregnant or lactating women;
- •Patients with a history of alcohol abuse and drug abuse;
- •Have a history of serious mental illness or family history; 13 Other reasons researchers believe that patients are not suitable for this study.
研究组 & 干预措施
Moving cupping placebo control
Participants will received moving cupping placebo therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment.
干预措施: Moving cupping placebo (Device)
Moving cupping intervention
Participants will received moving cupping therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment.
干预措施: Moving cupping (Device)
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)
- Visual Analogue Score (VAS)(Up to 56 days after treatment)
- CM symptom score(Up to 28 days after treatment)
- Physician Global Assessment (PGA)(Up to 56 days after treatment)
- Dermatology Life quality index(DLQI)(Up to 28 days after treatment)
- Patient-reported quality of life (PRQoL)(Up to 28 days after treatment)