Clinical Trial of PSORI-CM01（YXBCM01） Granule to Treat Stable Plaque Psoriasis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Double-blind, Randomized, Placebo-controlled Trial of PSORI-CM01（YXBCM01） Granule for Stable Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: PSORI-CM01（YXBCM01） granule
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSORI-CM01（YXBCM01）granule<br>PSORI-CM01（YXBCM01）granule 1.1g os once a day for 12weeks. | Drug: PSORI-CM01（YXBCM01） granule<br> <br> * Other names: Chinese Hebal Medicine;|
| Experimental: PSORI-CM01（YXBCM01）granule low dose group<br>PSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks. | Drug: PSORI-CM01（YXBCM01） granule<br> <br> * Other names: Chinese Hebal Medicine;Drug: placebo<br> <br> |
| Placebo Comparator: placebo<br>Placebo granule 1.1g os once a day for 12weeks. | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI-50 | The number of patients who achieve at least 50% improvement in PASI score from baseline. | 12 weeks (plus or minus 3 days) after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI(Psoriasis Area and Severity Index) | The improvement in PASI score from baseline. | 12 weeks (plus or minus 3 days) after treatment | 
| PASI-75 | The number of patients who achieve at least 75% improvement in PASI score from baseline. | 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） | the Body Surface Area | 12 weeks (plus or minus 3 days) after treatment | 
| DLQI（Dermatology Life Quality Index） | the Dermatology Quality Life Index | 12 weeks (plus or minus 3 days) after treatment | 
| Relapse rate in treatment period / follow-up period | Relapse can be defined only for patients who achieve PASI50，and occurs when the improvement in the PASI score falls below 50% from the baseline PASI score. | 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 | Relapse time interval refers to the time when patients who achieve PASI-50 for the first time until first relapse occurs. | During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period | 
| Rebound rate | Rebound can be defined only for patients who achieve PASI50，and occurs when the improvement in the PASI score increase up to 25% from the baseline PASI score. | During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stable Plaque Psoriasis