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| Name | Class |
|---|---|
| Henan Provincial People's Hospital | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
This is a randomized, double blind, placebo parallel-controlled, multi-center clinical trial. Patients with psoriasis vulgaris were randomly divided into the experiment group (treated with TGP combined with acitretin capsules) and control group (treated with placebo combined with acitretin capsules).The treatment lasted 12 weeks. The efficacy and safety were evaluated at the baseline, as well as 2, 4, 8 and 12 weeks after the beginning of treatment.The investigator's hypothesis TGP combined with Acitretin Capsulesin is more safe and effective than Acitretin Capsulesin to treat Psoriasis Vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total glucosides of paeony & Acitretin Capsules | Experimental | During the first week,0.6g,oral,b.i.d.During the other weeks,0.6g,oral,t.i.d |
|
| Acitretin Capsules | Active Comparator | 20mg/day oral,when subject's weight less than 70kg;otherwise,30mg/day oral. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total glucosides of paeony & Acitretin Capsules | Drug |
| ||
| Acitretin Capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Psoriasis Area and Severity Index | After 12 weeks treatment, relative to baseline, the proportion of patients achieving a 50% reduction in Psoriasis Area and Severity Index 50 (PASI50) was 90% in the experiment group and 70.5% in the control group (P<0.05). | week 0 and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of elevated Alanine aminotransferase | After 12 weeks treatment, relative to baseline,the incidence of elevated Alanine aminotransferase (ALT) was 6.8% in the experiment group and 22.2% in the control group (P<0.05). | week 0 and week12 |
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Inclusion Criteria:Meet the following conditions
Exclusion Criteria:One of the following is not included in this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospitial | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017255 | Acitretin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Drug |
|
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |