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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
35
Chronic Disease Prevention and Control Station of Panyu District in Guangzhou
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
PASI-50
The number of patients who achieve at least 50% improvement in PASI score from baseline.
Time frame: 12 weeks (plus or minus 3 days) after treatment
PASI(Psoriasis Area and Severity Index)
The improvement in PASI score from baseline.
Time frame: 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.
Time frame: 12 weeks (plus or minus 3 days) after treatment
Pruritus Scores on the Visual Analogue Scale
Time frame: 12 weeks (plus or minus 3 days) after treatment
BSA（Body Surface Area）
the Body Surface Area
Time frame: 12 weeks (plus or minus 3 days) after treatment
DLQI（Dermatology Life Quality Index）
the Dermatology Quality Life Index
Time frame: 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.
Time frame: 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
Time frame: During the treatment period of 12 weeks
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Relapse time interval
Relapse time interval refers to the time when patients who achieve PASI-50 for the first time until first relapse occurs.
Time frame: 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.
Time frame: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period