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Multi-center, Randomized, Double Blind, Placebo Parallel-Controlled Study of the Efficacy and Safety of Total Glucosides of Paeony Combined With Acitretin Capsules to Treat Psoriasis Vulgaris
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.
Details
| Lead sponsor | Xijing Hospital |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 108 |
| Start date | 2013-02 |
| Completion | 2013-10 |
Conditions
- Psoriasis
Interventions
- Total glucosides of paeony & Acitretin Capsules
- Acitretin Capsules
Primary outcomes
- Reduction in Psoriasis Area and Severity Index — week 0 and week 12
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).
Countries
China