A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trials to Evaluate the Efficacy and Safety of Runzao Zhiyang Capsule in Treating Chronic Eczema
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 9
- 主要终点
- The efficiency(The number of cured cases and cases with marked effect) of disease： Using EASI score decline rate to judge. The decline rate of EASI = (before treatment EASI- After treatment EASI)/ before treatment EASI×100%
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.
详细描述
Polygoni multiflori Preparata, dried rehmannia root, mulberry leaf, sophora flavescens, Honghuoma, for skin itching, acne, constipation due to blood vacuity and wind-dryness, also used in clinical treatment of eczema.
The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consistent with diagnostic criteria for chronic eczema(Referring to "the Chinese eczema diagnosis and treatment guidelines" in 2011);
- •Investigator Global Assessment (IGA) score was 2 or 3;
- •The skin lesions were localized, hypertrophy and dry, and the affected skin area was 3%~10% of body surface area (estimated by palm method); the diameter of target lesions was 2~10cm and located in the limbs or trunk.
- •The course of chronic eczema is more than 6 months;
- •Age 18 to 70, males or females;
- •The Subjects obtain informed consent, participated the trial voluntarily. Procedure to obtain informed consent is in accordance with the provisions of Good Clinical Practise(GCP).
排除标准
- •Subjects with acute eczema, subacute eczema, universal eczema, special type of eczema;
- •Subjects used corticosteroids, immunosuppressive agents and ultraviolet irradiation in 4 weeks prior to the enrollment;
- •Subjects were treated with antihistamine and topical drugs in 2 weeks;
- •Women in Pregnancy, Lactation, or Planned pregnancy during the test;
- •Comorbid with severe primary heart, liver, lung, kidney, blood disease, diabetes, thyroid disease or a serious disease affecting survival, such as cancer or HIV / AIDS;
- •Subjects were allergic to test drug ingredients;
- •Subjects could not give full informed consent because of mental and behavioral disorders;
- •Suspected or identified with a history of alcohol or drug abuse;
- •Have other diseases or conditions which may reduce the possibility of enrollment or complicate the recruiting process based on the investigator judgment. For example, working environment changed frequently led to easily lost follow-up;
- •Have been or currently enrolled in other clinical trials within 3 months.
研究组 & 干预措施
Runzaozhiyang capsule agent simulation
Runzaozhiyang capsule agent simulation:4 pills each time, 3 times a day, oral, Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day.
干预措施: Runzaozhiyang capsule agent simulation (Drug)
Runzao zhiyang capsule
Runzao zhiyang capsule: 4 pills each time, 3 times a day, oral， Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day.
干预措施: Runzao zhiyang capsule (Drug)
Runzao zhiyang capsule
Runzao zhiyang capsule: 4 pills each time, 3 times a day, oral， Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day.
干预措施: Urea cream (Drug)
Runzaozhiyang capsule agent simulation
Runzaozhiyang capsule agent simulation:4 pills each time, 3 times a day, oral, Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day.
干预措施: Urea cream (Drug)
结局指标
主要结局
The efficiency(The number of cured cases and cases with marked effect) of disease： Using EASI score decline rate to judge. The decline rate of EASI = (before treatment EASI- After treatment EASI)/ before treatment EASI×100%
时间窗: 0,4 weeks
次要结局
- The decrease rate of EASI in each visit compare with baseline(0,2,4,8,12 weeks)
- Changes in the degree of pruritus（test by visual analogue scale） in the follow-up visits compared with baseline(0,2,4,8,12 weeks)
- DLQI (Dermatology Life Quality Index) score changes during the follow-up visits compared with baseline.(0,2,4,8,12 weeks)
- The proportion of patients (EASI score greater than 10% of the patients before treatment)(8,12 weeks)
- EASI score(8,12 weeks)