Efficacy and Safety Study of Total Glucosides of Paeony Combined With Acitretin to Treat Psoriasis

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Drug: Acitretin Capsules; Drug: Total glucosides of paeony & Acitretin Capsules

• Registration Number: NCT02191020
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2014-01-08
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-11
• Last Update Submitted: 2014-07-11
• Study First Posted: 2014-07-15
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Meet the following conditions

1. Diagnosed according to Classification criteria for Psoriasis vulgaris;
2. Patients aged 18 to 65 years (to the date of screening);
3. PASI grade>7point<20 point;
4. Not treatment in the Topical corticosteroids、Immunosuppresso、Biologicals agents or Tretinoin cream、Phototherapy nearly one months before enrolled.
5. Understanding the whole process of the study, voluntary participation and signed the informed consent;
6. Patient compliance is good, can guarantee in course of observation.

Exclusion Criteria

One of the following is not included in this study:

1. Pregnant women, ready to pregnant or lactating women;
2. Known to root of herbaceous peony total glycosides (TGP) drug allergy;
3. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
4. Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers;
5. Need insulin control of diabetes; High blood pressure did not get good controller ;
6. Patients with white blood cells <4.0 × 109 / L, or a definite anemia (hemoglobin less than 100g / L), or platelets <100 × 109 / L, or other blood disease;
7. Patients with chronic diarrhea, or peptic ulcer nearly 1 year;
8. Patients suffering from malignant tumor;
9. Patients suffering from acute and chronic infectious diseases;
10. Mental disorders, history of alcohol abuse, drug or other substance abuse; 11. Other cases which researchers believe that can not enroll.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acitretin Capsules	Acitretin Capsules	20mg/day oral,when subject's weight less than 70kg;otherwise,30mg/day oral.
Total glucosides of paeony & Acitretin Capsules	Total glucosides of paeony & Acitretin Capsules	During the first week，0.6g，oral，b.i.d.During the other weeks，0.6g，oral，t.i.d

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
incidence of elevated Alanine aminotransferase	week 0 and week12	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).

Trial Locations

Locations (1)

Xijing Hospitial; 🇨🇳 Xi'an, Shaanxi, China