This study will evaluate the efficacy and safety of Jiuweihuaban Pill in the treatment of moderate to severe plaque psoriasis(syndrome of blood-heat ).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
Jiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks.
Low dose Jiuweihuaban pill 1 bag(3 g placebo per bag and 9 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.
High dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.
Beijing traditional Chinese medicine hospital affiliated to Capital Medical University
Beijing, China
RECRUITINGAffiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, China
PASI 75
Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days84.
Time frame: Baseline to days 84.
PASI75
Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days 28、56.
Time frame: Baseline to days 28、56.
PASI50、90
Proportion of subjects achieving an improvement of ≥50% and ≥90% in Psoriasis Area and Severity Index (PASI50, PASI90) from baseline at days 28、56、84.
Time frame: Baseline to days 28、56、84.
Change value and percentage change in PASI score
Change value and percentage change in PASI score from baseline at days 84.The PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, corresponding to maximal signs of psoriasis.
Time frame: Baseline to days 84.
Proportion of subjects achieving sPGA=0 or 1
Proportion of subjects achieving clear (score of 0) or almost clear (score of 1) in static Physician Global Assessment (sPGA=0 or 1) at Weeks 4, 8, and 12.
Time frame: Baseline to days 28、56、84.
Proportion of subjects achieving an improvement of ≥2 points in sPGA
Proportion of subjects achieving an improvement of ≥2 points in static Physician Global Assessment from baseline at days 28、56、84.
Time frame: Baseline to days 28、56、84.
Change value and percentage change in BSA affected by psoriasis
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The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, China
RECRUITINGChengdu Second People's Hospital
Chengdu, China
RECRUITINGAffiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, China
RECRUITINGYunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, China
RECRUITINGNanyang First People's Hospital
Nanyang, China
RECRUITINGThe First Affiliated Hospital of China Medical University
Shenyang, China
RECRUITINGAffiliated Hospital of Tianjin Institute of Traditional Chinese Medicine
Tianjin, China
RECRUITINGFirst affiliated hospital of Wenzhou medical university
Wenzhou, China
RECRUITING...and 2 more locations
Change value and percentage change in Body Surface Area (BSA) affected by psoriasis from baseline at days 28、56、84.
Time frame: Baseline to days 28、56、84.
Change value and percentage change in NRS for skin itching
Change value and percentage change in Numeric Rating Scale (NRS) for skin itching from baseline at days 28、56、84. The NRS scores can range from 0,corresponding to no itching symptom,up to a maximum of 10,corresponing to the most severe itching .
Time frame: Baseline to days 28、56、84.
Change value and percentage change in DLQI score
Change value and percentage change in Dermatology Life Quality Index (DLQI) score from baseline at days 28、56、84. The DLQI scores can range from 0 to 30.The higher the score, the worse the quality of life.
Time frame: Baseline to days 28、56、84.
Proportion of subjects achieving DLQI=0-1
Proportion of subjects achieving a DLQI score of 0-1 (DLQI=0-1) at days 28、56、84.The DLQI scores can range from 0 to 30.The higher the score, the worse the quality of life.
Time frame: Baseline to days 28、56、84.
Change value and percentage change in Traditional Chinese Medicine Syndrome score
Change value and percentage change in Traditional Chinese Medicine Syndrome score from baseline at days 28、56、84.The Traditional Chinese Medicine Syndrome scores can range from 0 to 27.The higher the score, the more severe psoriasis.
Time frame: Baseline to days 28、56、84.
Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome
Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome at days 28、56、84.
Time frame: Baseline to days 28、56、84.