Multi-center, Randomized, Double Blind, Placebo Parallel-Controlled Study of the Efficacy and Safety of Total Glucosides of Paeony Combined With Acitretin Capsules to Treat Psoriasis Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Reduction in Psoriasis Area and Severity Index
研究概览
简要总结
This is a randomized, double blind, placebo parallel-controlled, multi-center clinical trial. Patients with psoriasis vulgaris were randomly divided into the experiment group （treated with TGP combined with acitretin capsules) and control group （treated with placebo combined with acitretin capsules）.The treatment lasted 12 weeks. The efficacy and safety were evaluated at the baseline, as well as 2, 4, 8 and 12 weeks after the beginning of treatment.The investigator's hypothesis TGP combined with Acitretin Capsulesin is more safe and effective than Acitretin Capsulesin to treat Psoriasis Vulgaris.
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
- •Meet the following conditions
- •Diagnosed according to Classification criteria for Psoriasis vulgaris;
- •Patients aged 18 to 65 years (to the date of screening);
- •PASI grade>7point<20 point;
- •Not treatment in the Topical corticosteroids、Immunosuppresso、Biologicals agents or Tretinoin cream、Phototherapy nearly one months before enrolled.
- •Understanding the whole process of the study, voluntary participation and signed the informed consent;
- •Patient compliance is good, can guarantee in course of observation.
排除标准
- •One of the following is not included in this study:
- •Pregnant women, ready to pregnant or lactating women;
- •Known to root of herbaceous peony total glycosides (TGP) drug allergy;
- •Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
- •Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers;
- •Need insulin control of diabetes; High blood pressure did not get good controller ;
- •Patients with white blood cells <4.0 × 109 / L, or a definite anemia (hemoglobin less than 100g / L), or platelets <100 × 109 / L, or other blood disease;
- •Patients with chronic diarrhea, or peptic ulcer nearly 1 year;
- •Patients suffering from malignant tumor;
- •Patients suffering from acute and chronic infectious diseases;
- •Mental disorders, history of alcohol abuse, drug or other substance abuse;
- •Other cases which researchers believe that can not enroll.
研究组 & 干预措施
Total glucosides of paeony & Acitretin Capsules
During the first week，0.6g，oral，b.i.d.During the other weeks，0.6g，oral，t.i.d
干预措施: Total glucosides of paeony & Acitretin Capsules (Drug)
Acitretin Capsules
20mg/day oral,when subject's weight less than 70kg;otherwise,30mg/day oral.
干预措施: Acitretin Capsules (Drug)
结局指标
主要结局
Reduction in Psoriasis Area and Severity Index
时间窗: week 0 and week 12
After 12 weeks treatment, relative to baseline, the proportion of patients achieving a 50% reduction in Psoriasis Area and Severity Index 50 (PASI50) was 90% in the experiment group and 70.5% in the control group (P\<0.05).
次要结局
- incidence of elevated Alanine aminotransferase(week 0 and week12)
研究者
xjpfW
Chief in Department of Dermatology
Xijing Hospital