A Double-blind, Randomized, Placebo-controlled Trial of PSORI-CM01（YXBCM01） Granule for Stable Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- PASI-50
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Chinese herbal PSORI-CM01（YXBCM01） granule for stable plaque psoriasis, with blood stasis syndrome of Chinese Medicine.
详细描述
Psoriasis is an immune-abnormal, chronic, proliferative skin disease characterized by scaly, erythematous patches and papules. An epidemiological survey found Chinese prevalence showed an upward trend in recent years. The disease has great influence on patients' appearance,health and quality of life. Some Chinese Herbal Medicine (CHM) therapies have shown long lasting therapeutic effect on controlling psoriasis vulgaris and with minimal side effects.CHM can alleviate the symptoms effectively,and reduce the recurrence rate of diseases. PSORI-CM01（YXBCM01）granule is one kind of CHM which is observed effective and safe to treat stable stable plaque psoriasis with blood stasis syndrome in clinical practice.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable plaque psoriasis, duration > 1 year.
- •Patients with Chinese medicine blood stasis syndrome. (2)18 to 65 years old, male or female patient.
- •Mild psoriasis:3<PASI≤10, and BSA≤10%.
- •Informed consent.
排除标准
- •Guttate psoriasis, inverse psoriasis or exclusively involves the face;
- •Acute progression of psoriasis, and erythroderma tendency.Not blood stasis syndrome.Not stable psoriasis.
- •Pregnant, lactating, or which one plan to become pregnant in a year;
- •SAS（Self-rating Anxiety Scale）> 50 or SDS（Self-rating Depression Scale）> 53, or with other psychiatric disorders;
- •With history of cardiovascular, respiratory, digestive, urinary, and hematologic disease, which can't controlled through common treatment. Either with cancer, infection, electrolyte imbalance, acid-base disturbance and calcium metabolic disorder.
- •Allergic to any medicine or ingredients used in this study.
- •Participating other clinical trials or participated within 1 month.
- •Topical treatments (i.e. corticosteroids, Retinoic acid) within 2 weeks; systemic therapy or phototherapy (UVB and PUVA) within 4 weeks; biological therapy within 12 weeks.
- •Patients need systemic treatment prescribed by doctors.
研究组 & 干预措施
PSORI-CM01（YXBCM01）granule
PSORI-CM01（YXBCM01）granule 1.1g os once a day for 12weeks.
干预措施: PSORI-CM01（YXBCM01） granule (Drug)
PSORI-CM01（YXBCM01）granule low dose group
PSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks.
干预措施: PSORI-CM01（YXBCM01） granule (Drug)
PSORI-CM01（YXBCM01）granule low dose group
PSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks.
干预措施: placebo (Drug)
placebo
Placebo granule 1.1g os once a day for 12weeks.
干预措施: placebo (Drug)
结局指标
主要结局
PASI-50
时间窗: 12 weeks (plus or minus 3 days) after treatment
The number of patients who achieve at least 50% improvement in PASI score from baseline.
次要结局
- PASI(Psoriasis Area and Severity Index)(12 weeks (plus or minus 3 days) after treatment)
- PASI-75(12 weeks (plus or minus 3 days) after treatment)
- Pruritus Scores on the Visual Analogue Scale(12 weeks (plus or minus 3 days) after treatment)
- BSA（Body Surface Area）(12 weeks (plus or minus 3 days) after treatment)
- DLQI（Dermatology Life Quality Index）(12 weeks (plus or minus 3 days) after treatment)
- Relapse rate in treatment period / follow-up period(During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period)
- Time interval for patients the first time to achieve PASI-50 from baseline(During the treatment period of 12 weeks)
- Relapse time interval(During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period)
- Rebound rate(During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period)
研究者
Chuanjian Lu
Doctor
Guangdong Provincial Hospital of Traditional Chinese Medicine