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This study will evaluate the efficacy and safety of Jiuweihuaban Pill in the treatment of moderate to severe plaque psoriasis(syndrome of blood-heat ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Jiuweihuaban Pill placebo, 1 bag each time, p.o. , tid |
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| Low dose group | Experimental | Jiuweihuaban Pill , 1 bag each time, p.o. , tid |
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| High dose group | Experimental | Jiuweihuaban Pill , 1 bag each time, p.o. , tid |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jiuweihuaban Pill placebo | Drug | Jiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| PASI 75 | Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days84. | Baseline to days 84. |
| Measure | Description | Time Frame |
|---|---|---|
| PASI75 | Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days 28、56. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Liu | Contact | 022-86343626 | liurui2@tasly.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing traditional Chinese medicine hospital affiliated to Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| low dose Jiuweihuaban Pill | Drug | Low dose Jiuweihuaban pill 1 bag(3 g placebo per bag and 9 g Jiuweihuaban pill ),p.o.,tid,for 12weeks. |
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| high dose Jiuweihuaban Pill | Drug | High dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks. |
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| 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. | 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. | 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. | Baseline to days 28、56、84. |
| Change value and percentage change in BSA affected by psoriasis | Change value and percentage change in Body Surface Area (BSA) affected by psoriasis from baseline at days 28、56、84. | 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 . | 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. | 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. | 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. | 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. | Baseline to days 28、56、84. |
| Affiliated Hospital of Changchun University of Traditional Chinese Medicine | Recruiting | Changchun | China |
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| The First Affiliated Hospital of Hunan University of Chinese Medicine | Recruiting | Changsha | China |
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| Chengdu Second People's Hospital | Recruiting | Chengdu | China |
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| Affiliated Hospital of Shandong University of Traditional Chinese Medicine | Recruiting | Jinan | China |
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| Yunnan Provincial Hospital of Traditional Chinese Medicine | Recruiting | Kunming | China |
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| Nanyang First People's Hospital | Recruiting | Nanyang | China |
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| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | China |
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| Affiliated Hospital of Tianjin Institute of Traditional Chinese Medicine | Recruiting | Tianjin | China |
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| First affiliated hospital of Wenzhou medical university | Recruiting | Wenzhou | China |
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| The Second Affiliated Hospital of Xiamen Medical College | Recruiting | Xiamen | China |
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| Xingtai people's hospital | Recruiting | Xingtai | China |
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