Pilot Study of Traditional Chinese Medicine (Qing-Re-Liang-Xue Decoction) as Complementary Medicine for Psoriasis Vulgaris of Blood-heat Syndrome.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- participants achieving either a major clinical response or partial clinical response defind by Psoriasis Area Severity Index (PASI) over the 10 weeks treatment period.
研究概览
简要总结
Psoriasis is a non-contagious erythematous scaly skin disease characterized by epidermal proliferation and inflammation. The etiology is related to heredity, infection, allergies, metabolic disorders and autoimmunity. The incidence of psoriasis in the survey was about 1.2‰ in 1984 in China, and 2.6% in the United States. In recent years, the incidence of psoriasis has been on the increase trend, mostly in the young to middle age adults, and it can last a lifetime. The characteristic of the disease is that it usually spreads all over the body, or gradually aggravates, or is fixed and difficult to subside,or the disease course is long, lingering and difficult to heal, and it brings great harm to the patient's body and mind. At present, there is no effective treatment for psoriasis. Although western medicine has good short-term curative effects, prolonged use is not advocated because of adverse side effects and poor long-term effects. Besides, it is easy to relapse and aggravate after stopping the medicine. Psoriasis belongs to the category of "baibi" in Chinese medicine. Doctors of the past dynasties mostly treated it from blood heat, blood stasis, and blood deficiency syndrome. Researcher Zhu Renkang believes that "blood with heat" is the main cause of psoriasis and famous TCM dermatologists such as Zhang Zhili, Gu Bohua, Xu Yihou and others all regard "blood-heat syndrome" as the basic pathogenesis of psoriasis. We used Qingre Liangxue Recipe Granules to observe the treatment of 31 patients with blood-heat type psoriasis vulgaris, and found that the PASI index of the patients after treatment was significantly lower than before treatment (P <0.01), and the serum VEGF level was significantly decreased (P < 0.01), the correlation analysis between the two showed a significant correlation. This study aims to further evaluate the efficacy and safety of Qing-Re-Liang-Xue Decoction in comparison with commonly used glucocorticoids and calcipotriol ointment in patients with blood-heat type psoriasis vulgaris.
详细描述
This is a multi-center, randomized, open-label, controlled pilot study of Traditional Chinese medicine (Qing-Re-Liang-Xue Decoction) as a complementary therapy to treat psoriasis vulgaris of blood-heat syndrome during a 10-week period. We estimate to enroll 200 subjects (treatment group(N=100); controlled group(N=100)).
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
- None
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
- •18-65 years;
- •Had a diagnosis of psoriasis vulgaris for ≥6 months;
- •TCM syndrome evaluation belongs to blood-heat type patients: it is more common in the advanced stage of psoriasis. Symptoms: skin lesions develop faster, skin lesions are bright red, blood loss is obvious, scales are dry and thick, itching is severe; upset, and thirsty, dry stool; red-purple tongue, yellow fur, string or slippery or rapid pulse;
- •Patients without serious primary diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system or mental illnesses;
- •Those who are willing to cooperate and can persist in the treatment without interruption;
- •During the treatment period, those who have not taken or used other psoriasis drugs externally.
排除标准
- •Patients with serious primary diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system or mental illnesses;
- •History of immunosuppressant medication in the past three months;
- •Those who use other drugs during treatment or stop treatment on their own and have incomplete observation data;
- •Pregnancy or risk of pregnancy, and/or lactation;
- •Aged ≤18 or ≥65 years old;
- •Patients with other types of psoriasis, such as articular, pustular, and erythroderma.
研究组 & 干预措施
Qing-Re-Liang-Xue Decoction.
One dose of granules is mixed, poured into 500ml of boiling water, and taken twice in the morning and afternoon. Women stop taking Chinese medicine during the first 3 days of menstruation. Triamcinolone Acetonide Acetate and Urea Cream,10g/tube and Calcipotriol Ointment,10g/tube are used alternately. The period of treatment will be 10 weeks.
干预措施: Qing-Re-Liang-Xue Decoction. (Drug)
control group
Topical steroids. Triamcinolone Acetonide Acetate and Urea Cream,10g/tube and Calcipotriol Ointment,10g/tube are used alternately. The period of treatment will be 10 weeks.
干预措施: Triamcinolone Acetonide Acetate and Urea Cream. (Drug)
结局指标
主要结局
participants achieving either a major clinical response or partial clinical response defind by Psoriasis Area Severity Index (PASI) over the 10 weeks treatment period.
时间窗: 10 weeks
Psoriasis Area Severity Index (PASI) is usually used to measure the clinical activity diseases of psoriasis.
次要结局
- Changes in skin lesions are assessed by dermoscope.(10 weeks.)
- Evaluation of curative effect of Traditional Chinese medicine is assessed by patient reported outcome(PRO) and clinician reported outcomes(CRO).(10 weeks.)
- Compliance evaluation is assessed by Counting Days of Treatment.(10 weeks.)