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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Total glucosides of paeony & Acitretin Capsules; Drug: Acitretin Capsules

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospitial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Total glucosides of paeony & Acitretin Capsules
Active Comparator: Acitretin Capsules; 20mg/day oral,when subject's weight less than 70kg;otherwise,30mg/day oral.	Drug: Acitretin Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Henan Provincial People's Hospital; The First Affiliated Hospital of Dalian Medical University

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): July 15, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Psoriasis Vulgaris; Total Glucosides of Paeony(TGP); Acitretin Capsules
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Keratolytic Agents; Acitretin
• Other Study ID Numbers: XijingH-PF-20120909