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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02191020

Enrollment

108

Registered

2014-07-15

Start date

2013-02-28

Completion date

2013-10-31

Last updated

2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Total Glucosides of Paeony(TGP), Acitretin Capsules, Psoriasis Vulgaris

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.

Interventions

DRUGTotal glucosides of paeony & Acitretin Capsules

DRUGAcitretin Capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026