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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191020
• Other study ID #: XijingH-PF-20120909
• Status: Completed
• Phase: N/A
• First received: January 8, 2014
• Last updated: July 11, 2014
• Start date: February 2013
• Est. completion date: October 2013

Study information

• Verified date: July 2014
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Total glucosides of paeony & Acitretin Capsules

• Acitretin Capsules

Locations

Country	Name	City	State
China	Xijing Hospitial	Xi'an	Shaanxi

Sponsors (3)

Lead Sponsor	Collaborator
Xijing Hospital	Henan Provincial Hospital, The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes