Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome: A Randomized, Single-blind, Multicentre Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 92
- 试验地点
- 5
- 主要终点
- Psoriasis area and severity index (PASI)
研究概览
简要总结
This study was designed as a multicenter, randomized, single blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of plaque psoriasis with blood stasis syndrome, after treated with fire needle therapy.
详细描述
Psoriasis is a chronic inflammatory skin disease characterized by the complex interaction between the immune system, related susceptibility loci, autoantigens and various environmental factors. In China, the prevalence is about 0.47%. Current treatment strategies for psoriasis mainly focus on developing new drugs that disrupt IL-23 or IL-17 cytokine, but this targeted therapy is not effective for all patients. A growing body of evidence indicates that psoriasis-related damage is not limited to the skin, but is closely related to coronary heart disease, stroke, metabolic syndrome, and chronic kidney disease. These comorbidities have, to a certain extent, increased mortality in patients with psoriasis. Traditional Chinese medicine (TCM) has always been used to treat patients with psoriasis in China. Blood stasis syndrome is one of the basic syndromes of psoriasis. which accumulates in meridians, viscera and limbs to form a variety of syndromes with psoriasis for a long time and is similar to many metabolic related diseases. Fire needle therapy is one of the traditional Chinese specialty treatments, which has effects of warming yang to expel cold, warming and activating meridian, dispersing stasis and relieving pain. Studies have shown that fire needle therapy of plaque psoriasis in stationary phase is effective, with fewer side effects, and can reduce the recurrence rate. This multicenter, randomized, single-blind, placebo-controlled trial will objectively and standardly evaluate the clinical effectiveness, safety and control of recurrence of fire needle therapy to obtain objective evidence of international standards and form clinical norms suitable for popularization and application.
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
- •Comply with the diagnostic criteria of Western medicine for plaque 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
Fire needle group
Participants in experimental group will receive Fire needle 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: Fire needle (Other)
Fire needle placebo group
Participants in experimental group will receive Fire needle 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: Fire needle Placebo (Other)
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)
- Dermatology Life quality index(DLQI)(Up to 28 days after treatment)
- Patient-reported quality of life (PRQoL)(Up to 28 days after treatment)
- Visual Analogue Score (VAS)(Up to 56 days after treatment)
- TCM syndrome score(Up to 56 days after treatment)